L1641_A TriCor Surg Tech L1641 A Tri Cor Sacroiliac Joint Fusion System

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TriCor™ Sacroiliac Joint Fusion System

Surgical Technique

2 TriCor Sacroiliac Joint Fusion System – Surgical Technique

TriCor Sacroiliac Joint Fusion System

Surgical Technique

Description, Indications & Contraindications ..................3

Anatomy Overview ........................................4

Imaging Techniques .......................................5

Patient Preparation .......................................6

Intraoperative Imaging ....................................7

Pre-Op Planning ..........................................7

Open Surgical Technique ...................................8

Tissue Shield Surgical Technique ...........................20

Implant Removal and Adjustment Surgical Technique...........27

Instrument Visual Guide...................................28

Tray Layouts ............................................30

Warnings and Precautions.................................31

TriCor Sacroiliac Joint Fusion System – Surgical Technique 3

Description, Indications & Contraindications

INTRODUCTION

The TriCor System allows for fusion and

stabilization of the SI Joint in eligible patients

where appropriate non-surgical treatment

has failed. The TriCor Sacroiliac Joint Fusion

System is intended for sacroiliac joint

fusion for conditions including degenerative

sacroiliitis and sacroiliac joint disruptions.

The device optionally incorporates a

proprietary dual-pitch compression-thread

design and titanium plasma coating to

stabilize the SI Joint in fusion procedures. The

design of the implant allows for bone graft to

be introduced into the joint and implant in

order to promote fusion. The TriCor System is

a true bony fusion and arthrodesis system.

The implant and instrumentation suite allows

for direct exposure and preparation of the SI

Joint surface, placement of bone graft into the

SI Joint space under direct visualization, and

placement of bone graft directly within the

TriCor Implant itself.

The TriCor System consists of different

diameter implants in various lengths and

thread configurations to accommodate

variations in patient anatomy. The

TriCor Sacroiliac Joint Fusion System

is manufactured from titanium alloy in

accordance with ASTM F136, as well as an

optional version where exterior surfaces are

coated with medical-grade commercially pure

titanium (CP Ti) per ASTM F1580. All implants

are intended as single use only and should

not be reused under any circumstances.

Note: 12.5mm anchor implants are plasma-

coated, 7mm locking implants are not coated.

INDICATIONS

The TriCor Sacroiliac Joint Fusion System

is intended for sacroiliac joint fusion for

conditions including degenerative sacroiliitis

and sacroiliac joint disruptions.

CONTRAINDICATIONS

Contraindications for the TriCor Joint Fusion

System are similar to those of other systems

of similar design, and include, but are not

limited to:

1. Patients with probable intolerance to the

materials used in the manufacture of this

device.

2. Patients with infection, inflammation,

fever, tumors, elevated white blood

count, obesity, pregnancy, mental

illness and other medical conditions

which would prohibit beneficial surgical

outcome.

3. Patients resistant to following post-

operative restrictions on movement,

especially in athletic and occupational

activities.

4. Use with components from other

systems.

5. Grossly distorted anatomy caused by

congenital abnormalities.

6. Any other medical or surgical condition

which would preclude the potential

benefit of spinal implant surgery.

7. Rapid joint disease, bone absorption,

osteopenia. Osteoporosis is a relative

contraindication since this condition may

limit the degree of obtainable correction,

stabilization, and/or the amount of

mechanical fixation.

8. Any case where the implant components

selected for use would be too large or too

small to achieve a successful result.

9. Any patient having inadequate tissue

coverage over the operative site or

inadequate bone stock or quality.

10. Any patient in which implant utilization

would interfere with anatomical

structures or expected physiological

performance.

11. Any case not described in the indications

for use.

12. Reuse or multiple uses.

4 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Anatomy Overview

Structural Anatomy

Sacroiliac Joint

• Bicondylar synovial joint

• Joins the sacrum to the pelvis

• Weight-bearing, shock absorber

• “Kidney-bean” shape

• Strengthens ligamentous support and

irregular articular surfaces help to resist

shear forces

SI Joint

Sacrum

IliumIlium

SI Joint

SI Joint

TriCor Sacroiliac Joint Fusion System – Surgical Technique 5

Imaging Techniques

Posterior Sacral Wall (PSW)

Ala (2 lines superimposed)

Anterior Sacral Wall

Inferior Endplate L5

Superior Endplate S1

Greater Sciatic Notch

SI Joint

Superior Alar Surface

Inferior Endplate of L5

Superior Endplate of S1

S1 Foramen

S2 Foramen

1

3

2

54

6

SI Joint

S1 Foramen

S2 Foramen

L5 Nerve

Pelvic Brim

1

23

4

5

1

3

4

5

6

2

1

2

3

4

5

6

Lateral View

1

2

3

4

5

Inlet View (20-25 degrees Caudally)

1

2

3

4

5

6

Outlet View (40-60 degrees Cephalad)

6 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Patient Preparation

Sacral Canal

L5 nerve

S2 foramen

SI joint

S1 foramen

Posterior sacral wall

Sacral notch

Anterior sacral wall

Superior endplate S1

Ala

Inferior endplate L5

Greater sciatic notch

Superior

endplate S1

Inferior

endplate L5

SI joint

TriCor Sacroiliac Joint Fusion System – Surgical Technique 7

Intraoperative Imaging

Lateral View

In order to obtain a true lateral view, align

the alae so they are superimposed over one

another.

Outlet View

The SI joint, ilium, sacrum and sacral

foramen will be visible.

Operating Room Setup

• Patient positioned in a prone position

• Jackson or Flat table preferably

• C-Arm positioned on non-operative side

Pre-Op Planning

Inlet View

Tilt the C-Arm until a clear, strong pelvic brim

is seen; the anterior wall of the sacrum will

appear as one line.

8 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Instruments

Posterior Skin Incision Lateral Skin Marking and Incision

Open

Surgical Technique

Step 1

Make an incision along the posterior

two-thirds of the iliac crest following the

posterior superior iliac spine. Use preferred

retraction method to access and visualize

the symptomatic SI joint. Cut into the ilium

and remove a block of bone as well as any

necessary cartilage. Once the cartilage

removal is complete, place the bone back so it

contacts the sacral bone. Make sure the block

is secure in order to prepare for the SI joint for

bony arthrodesis. (Fig. 1)

NOTE: The Right Angled Curette or any other

preferred medical instruments may be used to

decorticate, remove cartilage and prepare the SI

joint for bony arthrodesis.

Step 2

Use the Exchange Pin to mark the Posterior

Sacral Wall (PSW, #1) and Sacral Alar Line

(#2) with a marking pen.

Make a skin incision along the Posterior

Sacral Wall, approximately 3-5cm in length,

starting at intersection with sacral ala skin

marking.

Beginning in the Lateral View, take the Trocar

Steinmann Pin and insert the Steinmann Pin

through the skin incision approximately 1cm

anterior to the Posterior Sacral Wall and 1cm

inferior to the ala. (Fig. 2)

NOTE: Use the #1 Tissue Shield to stabilize the

Trocar Steinmann Pin for impaction.

Fig. 1 SFig. 2 S

1

2

Trocar Steinmann Pin

07.02212.021

(X079-0054)

#1 Tissue Shield

07.02212.016

(X079-0045)

TriCor Sacroiliac Joint Fusion System – Surgical Technique 9

Instruments

Steinmann Pin Placement

Outlet View

The Trocar Steinmann Pin should be parallel

to S1 endplate. Mallet the Steinmann Pin in

final desired depth in Outlet view. (Fig. 3c)

NOTE: Blunt or Threaded Steinmann Pins are

available to replace the Trocar Steinmann Pin

after placement, if desired.

Fig. 3b SFig. 3c S

Inlet View

The angle of the Trocar Steinmann Pin should

be heading towards the middle of the sacrum.

(Fig. 3b)

Fig. 3a S

Step 3

Confirm placement in three views:

Lateral View

Place the Trocar Steinmann Pin approximately

1cm Anterior to the PSW and 1cm inferior to

the ala. (Fig. 3a)

Mallet

07.02212.019

(X034-0915)

10 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Measure Drill Assembly Drill

Instruments

Fig. 4 SFig. 6 S

Fig. 5 S

Step 4

Position #2 or #3 Tissue Shield over the

Steinmann Pin. While keeping the Tissue

Shield in place, use the Steinmann Pin Depth

Gage/Guide to select the appropriate implant.

Insert the Steinmann Pin Depth Gage/Guide

underneath the inserted Steinmann Pin and

dock onto the proximal end of the Tissue

Shield. Measure with the #3 Tissue Shield

for 12.5mm Implants and measure with #2

Tissue Shield for 7mm implants. Remove the

Tissue Shield. (Fig. 4)

NOTE: Utilize the correct side of the Steinmann

Pin Depth Gage/Guide; it is indicated for #2 and

#3 Tissue Shields.

Step 5

Attach the Drill bit to the Ratcheting T-Handle

or cordless power drill using the provided

Jacobs Chuck. (Fig. 5)

NOTE: Make sure the flat portion of the Jacobs

Chuck attachment fits flush to the walls if using

a cordless power drill.

NOTE: The drill flutes are designed to capture

the autogenous bone graft for reuse in the

12.5mm anchor implant.

Step 6

Place the Drill bit over the Steinmann Pin

slowly advancing until the ilium is reached.

Make sure the Drill is co-linear with the pin to

avoid binding on the pin.

Using the Outlet view, confirm accurate

placement of the Drill Bit over the Steinmann

Pin. Under fluoroscopic guidance continue to

advance the Drill just across the sacroiliac joint,

through the sacral cortex. Try to preserve the

sacral bone for re-packing the implant. (Fig. 6)

NOTE: Once the Drill reaches the SI joint,

exercise caution advancing into the sacrum.

NOTE: Once the Drill bit has reached the desired

depth as indicated by the markings on the shaft,

place the Exchange Pin down the cannulated

portion of the driver until it reaches the proximal

tip of the Steinmann Pin. Slowly remove the Drill

bit while keeping pressure on the Exchange Pin

to ensure the Steinmann Pin remains in place.

Steinmann Pin Depth

Gage/Guide

07.02212.001

(X079-0084)

Drill, Cannulated

07.02212.012 7.5mm

(X079-0034)

07.02212.024 12.5mm

(X079-0063)

Tissue Shields

07.02212.017 #2

(X079-0106)

07.02212.018 #3

(X079-0107)

Exchange Pin

07.02212.028

(X079-0089)

Ratcheting T-Handle

07.02212.031

(N60000472)

Jacobs Chuck Adaptor

07.02212.032

(N60001630)

TriCor Sacroiliac Joint Fusion System – Surgical Technique 11

Instruments

Tap Assembly Tap

Decortication and Sacroiliac

Joint Visualization

Fig. 8 SFig. 9 SFig. 7 S

Step 7

Attach the Tap to the Ratcheting T-Handle

(Fig. 7)

NOTE: Do not tap under power.

Step 8

Place the Tap over the Steinmann Pin, slowly

advancing until you reach the ilium. Make

sure the Tap is co-linear with the pin to avoid

binding on the pin.

Using the Outlet view, confirm placement.

Under fluoroscopic guidance continue to

advance the Tap across the sacroiliac joint,

through to the sacral cortex. Try to preserve

sacral bone for re-packing into the implant.

(Fig. 8)

NOTE: Once the Tap reaches the SI joint exercise

caution advancing into the Sacrum.

NOTE: Once the Tap has reached the desired

depth as indicated by the markings on the shaft,

place the Exchange Pin down the cannulated

portion of the driver until it reaches the proximal

tip of the Steinmann Pin. Slowly remove the Tap

while keeping pressure on the Exchange Pin to

ensure the Steinmann Pin remains in place.

Step 9

Take the Right Angle Curette and follow along

the Steinmann Pin down to the SI joint. Once

a tactile feel has been achieved, confirm in

the Outlet View to verify placement in the

joint. Rotate the instrument to prepare the SI

joint space for bony arthrodesis. Remove the

instrument once the site has been properly

prepared. (Fig. 9)

NOTE: A standard 2mm scope may be used

through the #3 Tissue Shield for additional SI

joint visualization.

Right Angle Curette

07.02212.020

(X079-0053)

Tap, Cannulated

07.02212.013 7mm

(X079-0035)

07.02212.025 12.5mm

(X079-0064)

12 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Bone Graft Pre-Pack

(12.5mm Implant Only)

Instruments

Fig. 10 SFig. 11 S

Step 10

Use the Graft Packing Block to pre-pack

selected implant with preferred bone grafting

choice. Place the distal tip of the implant on

the block and insert the bone graft into the

implant through the proximal end. (Fig. 10)

CAUTION: Do not over pack as implant will

obtain patient autograft during implantation.

12.5mm Graft Packing Block

07.02212.003

(X079-0067)

Step 11

Select the Implant Screwdriver and place onto the Ratcheting T-Handle. Select the

corresponding implant and place onto the distal tip of the driver, making sure the implant is

fully seated with the driver shaft. Insert the distal end of the implant over the Steinmann Pin and

advance the implant, under fluoroscopy, to desired depth. (Fig. 11)

12.5mm Implant Screwdriver

07.02212.023

(X079-0060)

TriCor System Bone Graft Volumes (Approximate)

12.5mm implants

LENGTH VOLUME

30mm 1.50cc

35mm 1.70cc

40mm 2.00cc

45mm 2.20cc

50mm 2.50cc

55mm 2.70cc

60mm 3.10cc

65mm 3.30cc

70mm 3.50cc

TriCor Sacroiliac Joint Fusion System – Surgical Technique 13

Instruments

Fig. 12a S

Implant Loading and

Final Placement

Fig. 12b SFig. 12c S

Step 12

Outlet View

Implant progression. Initial placement.

(Fig. 12a)

Outlet View

Implant progression.

(Fig. 12b)

Outlet View

Implant progression. Fully seated.

(Fig. 12c)

14 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Instruments

Steinmann Pin Depth Gage

Bone Graft Post Fill

(12.5mm Implant Only)

Step 14

After the Second Steinmann Pin placement

is confirmed, insert the Bone Graft Funnel

over the Steinmann Pin from the first implant.

Rotate the funnel until fully engaged with the

implant. Remove the Steinmann Pin from

the first implant once the Bone Graft Funnel

is in place. Next, insert the preferred bone

graft through the Bone Graft Funnel, following

with the Graft Tamp until fully seated with the

implant. (Fig. 14)

Fig. 14 S

Step 13

Using the first Steinmann Pin, insert the fixed

portion of the Steinmann Pin Depth Gage/

Guide over the already inserted pin. Under

fluoroscopy in the Lateral View, insert the

second pin following the curve of the sacrum.

Confirm in the three views (Lateral, Inlet, Outlet)

that the second Steinmann Pin placement

is accurate. Repeat steps above for implant

insertion of the subsequent implants.

(Fig. 13)

Fig. 13 S

Steinmann Pin Depth Gage/

Guide

07.02212.001

(X079-0084)

12.5mm Graft Funnel

07.02212.029

(X079-0080)

Graft Tamp

07.02212.002

(X079-0048)

Trocar Steinmann Pin

07.02212.021

(X079-0054)

TriCor Sacroiliac Joint Fusion System – Surgical Technique 15

Fig. 15a SFig. 15b SFig. 15c S

Second Implant Targeting

Instruments

Step 15

Repeat Step 3 for placement of the second

Trocar Steinmann Pin.

Lateral View (Fig. 15a)

Inlet View (Fig. 15b) Outlet View (Fig. 15c)

16 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Fig. 16a SFig. 16b SFig. 16c S

Second Implant Insertion

Instruments

Step 16

Repeat Steps 4-14.

Lateral View (Fig. 16a)

Inlet View (Fig. 16b) Outlet View (Fig. 16c)

TriCor Sacroiliac Joint Fusion System – Surgical Technique 17

Fig. 17a SFig. 17b SFig. 17c S

Third Implant Targeting

Instruments

Step 17

Repeat Step 3 for targeting of the third

implant.

Lateral View (Fig. 17a)

Inlet View (Fig. 17b) Outlet View (Fig. 17c)

18 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Fig. 18a SFig. 18b SFig. 18c S

Third Implant Insertion

Instruments

Step 18

Repeat Steps 4-14.

Lateral View (Fig. 18a)

Inlet View (Fig. 18b) Outlet View (Fig. 18c)

TriCor Sacroiliac Joint Fusion System – Surgical Technique 19

Fig. 19a SFig. 19b SFig. 19c S

Final Implant Construct

Instruments

Step 19

Confirm final implant placement using Lateral,

Inlet and Outlet views under fluoroscopy.

Lateral View (Fig. 19a)

Inlet View (Fig. 19b) Outlet View (Fig. 19c)

20 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Instruments

Skin Marking Skin Incision

Tissue Shield

Surgical Technique

Step 1

Use the Exchange Pin to mark the Posterior

Sacral Wall (PSW, #1) and Sacral Alar Line

(#2) with a marking pen. (Fig. 20)

Step 2

Make a skin incision along the Posterior

Sacral Wall, approximately 3-5cm in length,

starting at intersection with sacral ala skin

marking.

Beginning in the Lateral View, insert the

Trocar Steinmann Pin through skin incision

approximately 1cm anterior to the Posterior

Sacral Wall and 1cm inferior to the ala.

(Fig. 20)

Fig. 20 S

Exchange Pin

07.02212.028

(X079-0089)

1

2

TriCor Sacroiliac Joint Fusion System – Surgical Technique 21

Fig. 21a SFig. 21b SFig. 21c S

Steinmann Pin Placement

Instruments

Step 3

Confirm placement in 3 views:

Lateral View - Place Steinmann Pin

approximately 1cm anterior to PSW and 1cm

inferior to ala. (Fig. 21a)

Inlet View - The angle of Steinmann Pin

should be heading towards the middle of the

sacrum. (Fig. 21b)

Outlet View - The Steinmann Pin should

be parallel to the S1 endplate. Mallet the

Steinmann Pin in final desired depth in Outlet

view. (Fig. 21c)

Mallet

07.02212.019

(X034-0915)

NOTE: Blunt or Threaded Steinmann Pins are

available to replace the Trocar Steinmann Pin

after placement, if desired.

NOTE: Use the #1 Tissue Shield to stabilize the

Trocar Steinmann Pin for impaction.

Steinmann Pins

07.02212.021 Trocar

(X079-0054)

07.02212.022 Threaded

(X079-0057)

07.02212.027 Blunt

(X079-0086)

#1 Tissue Shield

07.02212.016

(X079-0045)

22 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Fig. 22 SFig. 23 S

Tissue Shield Placement Measuring/Implant Selection

Instruments

Step 4

Drop #1, 2 and 3 Tissue Shields, in sequence, over the Steinmann Pin. Once the #3 Tissue

Shield is in place, remove the #1-2 Tissue Shields. (Fig. 22)

NOTE: Optional Tissue Shield Guide Handle may be used for added stability.

Step 5

While keeping the Tissue Shield in place,

use the Steinmann Pin Depth Gage/Guide

to select appropriate implant. Insert the

Steinmann Pin Depth Gage underneath the

inserted Steinmann Pin and dock onto the

proximal end of the Tissue Shield. Measure

with #3 Tissue Shield for 12.5mm implants

and measure with #2 Tissue Shield for 7mm

implants. (Fig. 23)

NOTE: Utilize the correct side of the Steinmann

Pin Depth Gage/Guide; it is indicated for #2 and

#3 Tissue Shields.

Tissue Shield Guide Handle

07.02212.030

(X079-0090)

Tissue Shields

07.02212.016 #1

(X079-0045)

07.02212.017 #2

(X079-0106)

07.02212.018 #3

(X079-0107)

Steinmann Pin Depth Gage/

Guide

07.02212.001

(X079-0084)

TriCor Sacroiliac Joint Fusion System – Surgical Technique 23

Instruments

Fig. 24 S

Step 6

Attach the Drill bit to the Ratcheting T-Handle

or cordless power drill using the provided

Jacobs Chuck.(Fig. 24)

Drill Assembly Drill Tap Assembly

NOTE: Make sure the flat portion of the provided

Jacobs Chuck attachment fits flush to the walls if

using the cordless power drill.

Fig. 25 S

Step 8

Attach the Tap to the Ratcheting T-Handle.

(Fig. 26)

Fig. 26 S

Step 7

Place the Drill bit over the Steinmann Pin

slowly advancing until the ilium is reached.

Make sure that the Drill is co-linear with the

Pin to avoid binding on the Pin.

Using the Outlet view, confirm accurate

placement of the Drill bit over the Steinmann

Pin. Under fluoroscopic guidance, continue

to advance the Drill just across the sacroiliac

joint, through the sacral cortex. Try to preserve

sacral bone for re-packing the implant. (Fig. 25)

NOTE: Once the Drill reaches the SI joint,

exercise caution advancing into the sacrum.

NOTE: The drill flutes are designed to capture

the autogenous bone graft for reuse in the

12.5mm anchor implant.

CAUTION: Do not tap under power.

NOTE: Once the Drill bit has reached the desired

depth as indicated by the markings on the shaft,

place the Exchange Pin down the cannulated

portion of the driver until it reaches the proximal

tip of the Steinmann Pin. Slowly remove the Drill

bit while keeping pressure on the Exchange Pin to

ensure that the Steinmann Pin remains in place.

Drill

07.02212.012 7mm

(X079-0034)

07.02212.024 12.5mm

(X079-0063)

Ratcheting T-Handle

07.02212.031

(N60000472)

Jacobs Chuck Adaptor

07.02212.032

(N60001630)

Tap, Cannulated

07.02212.013 7mm

(X079-0035)

07.02212.025 12.5mm

(X079-0064)

Exchange Pin

07.02212.028

(X079-0089)

24 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Fig. 27 S

Step 9

Place the Tap over Steinmann Pin, slowly

advancing until you reach the ilium. Make

sure that the Tap is co-linear with the pin to

avoid binding on the pin.

Using the Outlet view, confirm placement.

Under fluoroscopic guidance continue to

advance the Tap across the sacroiliac joint,

through to the sacral cortex. Try to preserve

sacral bone for re-packing into the implant.

(Fig. 27)

Step 10

Take the Right Angle Curette and place

through the #3 Tissue Shield. Once a tactile

feel has been achieved, confirm in the Outlet

view to verify placement in the joint. Rotate

the instrument to prepare the SI joint space

for bony arthrodesis. Remove the instrument

once the site has been properly prepared.

(Fig. 28)

Fig. 28 SFig. 29 S

Tap

Decortication and Sacroiliac

Joint Visualization

Bone Graft Pre-Pack

(12.5mm Implant only)

Instruments

Step 11

Use the Graft Packing Block to pre-pack

selected implant with preferred bone grafting

choice. Place the distal tip of the implant on

the block and insert the bone graft into the

implant through the proximal end. (Fig. 29)

NOTE: A standard 2mm scope may be used

through the #3 Tissue Shield for additional SI

joint visualization.

CAUTION: Do not over pack as implant will

obtain patient autograft during implantation.

NOTE: Once the Tap reaches the SI joint exercise

caution advancing into the sacrum.

NOTE: Once the Tap has reached the desired

depth as indicated by the markings on the shaft,

place the Exchange Pin down the cannulated

portion of the driver until it reaches the proximal

tip of the Steinmann Pin. Slowly remove the Tap

while keeping pressure on the Exchange Pin to

ensure that the Steinmann Pin remains in place.

Right Angle Curette

07.02212.020

(X079-0053)

12.5mm Graft Packing Block

07.02212.003

(X079-0067)

TriCor System Bone Graft Volumes (Approximate)

12.5mm implants

LENGTH VOLUME

30mm 1.50cc

35mm 1.70cc

40mm 2.00cc

45mm 2.20cc

50mm 2.50cc

55mm 2.70cc

60mm 3.10cc

65mm 3.30cc

70mm 3.50cc

TriCor Sacroiliac Joint Fusion System – Surgical Technique 25

Fig. 30 S

Step 12

Select the Implant Screwdriver and place onto the Ratcheting T-Handle. Select the

corresponding implant and place onto the distal tip of the driver, making sure the implant is

fully seated with the driver shaft. Insert the distal end of the implant over the Steinmann Pin and

advance the implant, under fluoroscopy, to desired depth. (Fig. 30)

Fig. 31 S

Implant Loading and Final Placement Steinmann Pin Depth Gage

Instruments

Step 13

Using the first Steinmann Pin, insert the

Steinmann Pin Depth Gage/Guide starting

in the 0˚ position over the already inserted

pin. Under fluoroscopy in the Lateral view,

insert the second pin at the 20˚ marker while

following the curve of the sacrum. Confirm in

the three views (Lateral, Inlet, Outlet) that the

second Steinmann Pin placement is accurate.

Repeat steps above for implant insertion of

the subsequent implants. (Fig. 31)

Repeat steps 13-19 on pages 14-19 using the

Tissue Shield for the remaining two implants.

Steinmann Pin Depth Gage/

Guide

07.02212.001

(X079-0084)

Implant Screwdriver

07.02212.010 7mm

(X079-0030)

07.02212.023 12.5mm

(X079-0060)

26 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Fig. 32 S

Step 14

After the Second Steinmann Pin placement is confirmed, insert the Graft Funnel through the #3

Tissue Shield and over the Steinmann Pin from the first implant. Rotate the Graft Funnel until

fully engaged with the implant. Remove the Steinmann Pin from the first implant once the Graft

Funnel is in place. Next, insert the preferred bone graft through the Graft Funnel, following with

the Graft Tamp until fully seated with the implant. (Fig. 32)



Instruments



Bone Graft Post Fill

(12.5mm Implant only)

Step 15

Repeat steps 4-14 on pages 20-26 of the

Tissue Shield Technique for the remaining two

implants. Refer to pages 16-19 for images

showing implant placement.

Graft Tamp

07.02212.002

(X079-0048)

12.5mm Graft Funnel

07.02212.029

(X079-0080)

TriCor Sacroiliac Joint Fusion System – Surgical Technique 27

Instruments

Implant Removal and Adjustment

Implant

Removal and

Adjustment

Surgical Technique

After the Second Steinmann Pin placement:

Option #1 – 12.5mm Implant - Attach the

Ratcheting T-Handle to the 12.5mm Implant

Screwdriver, and locate the proximal end of

the implant that needs adjusting. Fully seat

the distal end of the Implant Screwdriver

into the desired implant. With the Ratcheting

T-Handle, rotate counterclockwise to adjust or

fully remove the implant. (Fig. 33)

Option #2 – 12.5mm Implant - Using

palpation and fluoroscopy, locate the

proximal end of the implant that needs

adjusting. Insert the distal end of the

12.5mm Implant Removal Instrument into the

desired implant until the initial fenestration

is reached. Rotate the implant removal tool

counter-clockwise or pull axially to adjust or

fully remove the implant.

NOTE: The knob at the proximal end of the

12.5mm Implant Removal Tool must be pulled

proximally during insertion into the implant.

Next, upon finding the fenestration, the knob is

pushed forward and locked to retain the

implant.

7mm Anchor Implant - Attach the Ratcheting

T-Handle to the 7mm Adjustment Screwdriver,

and, locate the proximal end of the implant

that needs adjusting. Fully seat the distal end

of the Implant Screwdriver into the desired

implant. With the Ratcheting T-Handle, rotate

counterclockwise to adjust or fully remove the

implant.

Fig. 33 S

12.5mm Implant Screwdriver

07.02212.010

(X079-0030)

7mm Adjustment Screwdriver

07.02212.011

(X079-0033)

Ratcheting T-Handle

07.02212.031

(N60000472)

12.5mm Implant Removal

Instrument

07.02212.033

(X079-0099)

28 TriCor Sacroiliac Joint Fusion System – Surgical Technique

Ratcheting T-Handle

07.02212.031

(N60000472)

Jacobs Chuck Adaptor

07.02212.032

(N60001630)

#1 Tissue Shield, Stainless Steel, 9mm

07.02212.016

(X079-0045)

#2 Tissue Shield, Stainless Steel, 13mm

07.02212.017

(X079-0106)

#3 Tissue Shield, Stainless Steel, 16mm

07.02212.018

(X079-0107)

Tissue Shield Guide Handle

07.02212.030

(X079-0090)

Implant Screwdrivers, Cannulated

07.02212.010 7mm

(X079-0030)

07.02212.023 12.5mm

(X079-0060)

Drills, Cannulated

07.02212.012 7mm

(X079-0034)

07.02212.024 12.5mm

(X079-0063)

Taps, Cannulated

07.02212.013 7mm

(X079-0035)

07.02212.025 12.5mm

(X079-0064)

Bone Awl, Cannulated

07.02212.014

(X079-0042)

12.5mm Graft Packing Block

07.02212.003

(X079-0067)

Mallet

07.02212.019

(X034-0915)

Instrument Visual Guide

TriCor Sacroiliac Joint Fusion System – Surgical Technique 29

12.5mm Graft Funnel

07.02212.029

(X079-0080)

Graft Tamp

07.02212.002

(X079-0048 )

Steinmann Pin Depth Gage/Guide

07.02212.001

(X079-0084)

Right Angle Curette

07.02212.020

(X079-0053)

12.5mm Implant Removal Instrument

07.02212.033

(X079-0099)

7mm Adjustment Screwdriver

07.02212.011

(X079-0033)

Cannula Cleaner

07.02212.015

(X079-0043)

Steinmann Pin

07.02212.021 Trocar

(X079-0054)

07.02212.022 Threaded

(X079-0057)

07.02212.027 Blunt

(X079-0086

Exchange Pin

07.02212.028

(X079-0089)

30 TriCor Sacroiliac Joint Fusion System – Surgical Technique

TriCor Sacroiliac Joint Fusion Instrument and Implant System

07.02211.400

Tray Layouts

Implants

Part Number Description Quantity

07.02211.001 Cannulated Screw, Dual Thread, Ø7mm x 30mm 2

07.02211.002 Cannulated Screw, Dual Thread, Ø7mm x 35mm 4

07.02211.003 Cannulated Screw, Dual Thread, Ø7mm x 40mm 4

07.02211.004 Cannulated Screw, Dual Thread, Ø7mm x 45mm 4

07.02211.005 Cannulated Screw, Dual Thread, Ø7mm x 50mm 4

07.02211.006 Cannulated Screw, Dual Thread, Ø7mm x 55mm 2

07.02211.007 Cannulated Screw, Dual Thread, Ø7mm x 60mm 4

07.02211.008 Cannulated Screw, Dual Thread, Ø7mm x 65mm 2

07.02211.009 Cannulated Screw, Dual Thread, Ø7mm x 70mm 2

07.02211.010 Washer, 13mm 4

07.02211.011 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 30mm 2

07.02211.012 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 35mm 2

07.02211.013 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 40mm 3

07.02211.014 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 45mm 3

07.02211.015 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 50mm 3

07.02211.016 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 55mm 3

07.02211.017 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 60mm 3

07.02211.018 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 65mm 2

07.02211.019 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 70mm 2

Instruments

Part Number Description Quantity Part Number Description Quantity

07.02212.001 Steinmann Pin Depth Gage/Guide 1 07.02212.017 #2 Tissue Shield, Stainless Steel, 13mm 1

07.02212.002 Graft Tamp 1 07.02212.018 #3 Tissue Shield, Stainless Steel, 16mm 1

07.02212.003 Graft Packing Block, 12.5mm 1 07.02212.019 Mallet 1

07.02212.004 Sterilization Case 1 07.02212.020 Right Angle Curette 1

07.02212.007 Steinmann Pin Holder (Trocar) 1 07.02212.023 Ø12.5mm Implant Screwdriver, Cannulated 2

07.02212.008 Steinmann Pin Holder (Threaded) 1 07.02212.024 Ø12.5mm Drill, Cannulated 2

07.02212.009 Instructions for Use 1 07.02212.025 Ø12.5mm Tap, Cannulated 1

07.02212.010 Ø7mm Implant Screwdriver, Cannulated 2 07.02212.026 Steinmann Pin Holder (Blunt) 1

07.02212.011 Ø7mm Adjustment Screwdriver, Cannulated 1 07.02212.029 Ø12.5mm Graft Funnel 1

07.02212.012 Ø7mm Drill, Cannulated 2 07.02212.030 Tissue Shield Guide Handle 2

07.02212.013 Ø7mm Tap, Cannulated 1 07.02212.031 Ratcheting T-Handle, 1/4" Drive 1

07.02212.014 Bone Awl, Cannulated 1 07.02212.032 Jacobs Chuck Adaptor, 1/4" Square 1

07.02212.015 350mm Stylet (.090"), Cannula Cleaner 1 07.02212.033 Ø12.5mm Implant Removal Instrument 1

07.02212.016 #1 Tissue Shield, Stainless Steel, 9mm 1

Single Use Instruments

Part Number Description Quantity

07.02212.021 Ø2.4mm x 300mm (.094") Steinmann Pin (Trocar) 5

07.02212.022 Ø2.4mm x 300mm (.094") Steinmann Pin (Threaded) 5

07.02212.027 Ø2.4mm x 300mm (.094") Steinmann Pin (Blunt) 5

07.02212.028 500mm Exchange Pin 2

TriCor Sacroiliac Joint Fusion System – Surgical Technique 31

Warnings and Precautions

WARNINGS

As with any surgical system, the TriCor

Sacroiliac Joint Fusion system should be used

by experienced surgeons with specific training

in the use of the spinal system because this is

a technically demanding procedure presenting

a risk of serious injury to the patient.

Knowledge of surgical techniques, proper

reduction, selection and placement of

implants, and pre- and post-operative

patient management are considerations

essential to a successful surgical outcome.

Appropriate selection, placement and fixation

of the spinal system components are critical

factors which affect implant service life. As

in the case of all prosthetic implants, the

durability of these components is affected by

numerous biologic, biomechanics and other

extrinsic factors, which limit their service

life. Accordingly, strict adherence to the

indications, contraindications, precautions,

and warnings for this product is essential to

potentially maximize service life. (Note: While

proper implant selection can minimize risks,

the size and shape of human bones present

limitations on the size, shape, and strength of

the implants).

Patients who smoke have been shown to have

an increased incidence of pseudoarthrosis.

Such patients should be advised of this fact

and warned of the potential consequences.

Patients with previous spinal surgery at

the level to be treated may have different

clinical outcomes compared to those without

a previous surgery. Based on the fatigue

testing results, the physician/surgeon should

consider the level of implantation, patient

weight, patient activity level, and other patient

conditions, etc. which may have an impact on

the performance of the system.

If the patient is involved in an occupation or

activity which applies inordinate stress upon

the implant (e.g. substantial walking, running,

lifting, or muscle strain) resultant forces can

cause failure of the device. In some cases,

progression of degenerative disease may be

so advanced at the time of implantation that

the expected useful life of the appliance may

be substantially decreased. In such cases,

orthopedic devices may be considered only as

a delaying technique or to provide temporary

relief. Patients should be instructed in

detail about the limitations of the implants,

including, but not limited to, the impact of

excessive loading through patient weight

or activity, and be taught to govern their

activities accordingly. The patient should

understand that a metallic implant is not

as strong as normal, healthy bone and will

bend, loosen or fracture if excessive demands

are placed on it. An active, debilitated, or

demented patient who cannot properly use

weight supporting devices may be particularly

at risk during postoperative rehabilitation.

Care must be taken to protect the components

from being marred, nicked or notched as

a result of contact with metal or abrasive

objects. Alterations will produce defects in

surface finish and internal stresses which may

become the focal point for eventual breakage

of the implant.

As with all orthopedic and neurosurgical

implants, none of the TriCor Sacroiliac Joint

Fusion System components should ever

be reused under any circumstances. Risks

associated with reuse include infection, non-

union (pseudarthrosis), serious patient injury

or death.

Due to the presence of implants, interference

with roentgenographic, CT and/or MR imaging

may result. The TriCor Sacroiliac Joint Fusion

System has not been evaluated for safety

and compatibility in the MR environment.

The TriCor Sacroiliac Joint Fusion System has

not been tested for heating or migration in

the MR environment. It must be noted that

there are several different manufacturers

and generations of MRI systems available,

and Zimmer Spine cannot make any claims

regarding the safety of Zimmer Spine implants

and devices with any specific MR system.

Physician Note: The physician is the learned

intermediary between the company and the

patient. The indications, contraindications,

warnings, and precautions given in this

document must be conveyed to the patient.

Contact your Zimmer Spine representative or visit us at www.zimmerspine.com

Distributed by:

Zimmer Spine

7375 Bush Lake Road

Minneapolis, MN 55439

800.655.2614

zimmerspine.com

L1641 Rev. A (2014-07)

(851S-1001-00)

© 2014 Zimmer Spine, Inc.

Disclaimer:

This documentation is intended exclusively for physicians and is not intended for laypersons. Information on the products and

procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or

recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard

to any individual medical case, each patient must be examined and advised individually, and this document does not replace the

need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information,

including, but not limited to, indications, contraindications, warnings, precautions, and adverse effects.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please see the product Instructions

for Use for a complete listing of the indications, contraindications, warnings, precautions and adverse effects.

Printed in U.S.A. Subject to change without notice.

EMERGO EUROPE

Molenstraat 15

2513 BH, The Hague

The Netherlands

Phone: +31.70.345.8570

Fax: +31.70.346.7299

Manufactured by:

X-spine Systems, Inc.

452 Alexandersville Road

Miamisburg, OH 45342

800.903.0640