ST 1010 01 Rev C Pedi Plates Surgical Technique

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O-Plate, I-Plate

and Delta

PediPlates®

SURGICAL TECHNIQUE

PediPlates®

O-PLATE, I-PLATE, DELTA

1

PediPlates®

TABLE OF CONTENTS

2

System Overview

System Overview ............................................................... 4

System Features ................................................................. 4

Surgical Approach .............................................................. 5

Guide Wire Inseron .......................................................... 5

Plate Placement ................................................................. 5

Distal Femoral Epiphyseal Guide Wire Inseron ..................... 6

Distal Femoral Metaphyseal Guide Wire Inseron .................. 7

Plate Posioning Conrmaon ............................................. 7

Epiphyseal Screw Inseron .................................................. 8

Metaphyseal Screw Inseron ............................................... 9

Final Tightening ................................................................ 10

Closure ............................................................................ 10

Product Informaon

O-Plate and I-Plate Implants ......…………….........……...………. 12

O-Plate and I-Plate Instrumentaon ................................... 13

PediPlate Delta Implants .…..…………...............…......…....…… 14

PediPlate Delta Instrumentaon .….....………….………….......... 14

Surgical Technique

Lateral Distal Femoral Physeal Tethering

Technical Tips

Technical Tips .........................…….......….........……..…….…. 11

PediPlates®

O-PLATE, I-PLATE, DELTA

3

PediPlates®

SYSTEM OVERVIEW

4

SYSTEM OVERVIEW

Physeal tethering techniques that do not disrupt the integrity of the physis have grown in popularity recently.

These techniques ulize simple plate and screw constructs which span the growth center restraining the physis.

The implant inhibits growth in the area where the plate and screws are applied. By tethering only one area of the

physis, growth is inhibited in that area and not inhibited in other areas of the growth center. If both sides of physis

are tethered, longitudinal growth may temporarily be retarded (for up to 2 years). This growth tethering is simple,

minimally invasive, temporary and reversible. Techniques that take advantage of open growth plates are unique and

allow for gradual correcon with signicantly less morbidity than other forms of growth arrest or inhibion such as

stapling or transphyseal screws.

SYSTEM FEATURES

• Stainless steel plates and screws provide excellent strength, resistance to breakage, as well as ease of removal.

• Mulple plate sizes and conguraons oer greater opons and more exibility.

• All screws are self-tapping for easy inseron.

• Ulizes 4.5mm stainless steel cannulated and non-cannulated screws with mulple screw length opons.

• Low-prole plates.

• Low-prole screws for use in areas where so-ssue irritaon is a consideraon.

• The O-Plate addresses the majority of paents needing simple two-hole physeal tethering.

• The Delta Plate addresses situaons where more exibility of screw placement is needed by oering

maximum diversion of screw placement through the plate.

• The I-Plate provides addional xaon opons ulizing four, rather than two screws.

PediPlates®

O-PLATE, I-PLATE, DELTA

5

SURGICAL TECHNIQUE

1

FIGURE 1: Surgical incision

FIGURE 3: Plate placement

FIGURE 2: Guide wire inseron into physis

3

Plate Placement

Select an appropriate sized plate and slide it over the guide wire

down to the bone (Figure 3).

2

Place Guide Wire in Physis

Using uoroscopic conrmaon, place the 1.6mm guide wire into

the physis ensuring that the guide wire is in the center of the distal

femoral condyles, anterior to posterior. Insert the guide wire

gently into the physis, about 1cm in depth (Figure 2).

1

Surgical Approach

Idenfy and locate the distal femoral physis with a metal object

and uoroscopy. Mark the skin and make a small incision

longitudinally. Gently dissect down to the peri-chondral ring

(Figure 1).

Note: Upon placement of guide wires throughout the procedure,

ensure there is no damage to the wire. Damage may result in

complicaons with the paent or interacons with other mang

devices.

Cauon: Avoid selecng inappropriate sized plate that would

allow placement of a screw into the physis or joint space.

Lateral Distal Femoral Physeal Tethering

PediPlates®

6

FIGURE 4a: Guide wire inseron into distal femoral epiphysis FIGURE 4b: 1.6mm side of drill guide must be

used for guide wire inseron

4

Insert 1.6mm Guide Wire into the Distal Femoral Epiphyseal Bone

Using the self-centering drill guide for the 1.6mm guide wire (Figure 4a and 4b), insert the wire under power into

the distal femoral epiphysis making sure that the wire is contained within the epiphysis. If the wire is close to the

physis or through the physis, remove it and reposion it. Using uoroscopy, conrm placement of the 1.6mm

guide wire prior to proceeding.

SURGICAL TECHNIQUE

1

2

Note: Ensure the double drill guide is centered within the epiphyseal hole especially when using a double drill guide

without the centering hole (01-1010-010).

Note: Prior to drilling, ensure power tool sengs are in the forward posion and no obstrucons are in the path of

intended drilling.

PediPlates®

O-PLATE, I-PLATE, DELTA

7

FIGURE 6: Plate posioning

FIGURE 5: Guide wire inseron into distal

femoral metaphysis

6

Conrm Plate Posioning

Using uoroscopy, conrm posion of plate and guide wires by

taking an A/P image and a lateral image (Figure 6). The ideal plate

placement is in the middle of the femoral condyle anterior to

posterior and in line longitudinally with the sha of the femur. It is

more important for the plate to be posioned in the center of the

distal femoral condyle, than it is to be in line longitudinally. If the

plate is posioned too far anterior or too far posterior, recurvatum

or procurvatum may be created.

5

Insert 1.6mm Guide Wire into the Distal Femoral

Metaphyseal Bone

Using the drill guide for the 1.6mm guide wire, insert the wire

under power into the distal femoral metaphysis making sure

to angle away from the physis (Figure 5). Conrm placement

of the 1.6mm guide wire with uoroscopy in the distal femoral

metaphysis.

PediPlates®

8

SURGICAL TECHNIQUE

1

FIGURE 7b: Drill over guide wire for the

epiphyseal screw

7

Measure and Drill for Epiphyseal Screw

Using the direct measuring device, idenfy the appropriate

screw length (Figure 7a). Drill over the 1.6mm guide wire using

the 3.2mm cannulated drill bit to pre-drill for inseron of the

screw (Figure 7b). It is not necessary to drill past the cortex. The

epiphyseal screw should be about one-third of the distance across

the segment of the bone.

If using the double drill guide with stop (01-1010-0210), advance

the 3.2mm cannulated drill bit unl it will no longer advance. This

will ensure you have only drilled the near cortex.

FIGURE 8: Epiphyseal screw inseron

FIGURE 7a: Read the direct measuring device

calibraon markings from the end of the guide

wire

8

Insert Epiphyseal Screw

Select the appropriate size of screw from the caddy. Size can be

conrmed using the scale on the screw caddy. To obtain accurate

measurement, be sure to push the screw forward on the scale so

that the screw head makes contact with the edge of the caddy.

Insert screw over guide wire into epiphysis ensuring screw is not

ghtened completely at this stage of inseron (Figure 8). Conrm

placement of the screw using uoroscopy.

Note: If the 3.2mm cannulated drill bit does not advance easily

over the 1.6mm guide wire, remove the drill bit and check the

integrity of the guide wire. If bent or damaged, the 3.2mm

cannulated drill bit may cause the guide wire to be inadvertently

advanced. If using a drill guide, check to be sure that the drill guide

is not damaged.

Cauon: If using a non cannulated screw, be sure to remove

the guide wire before inserng the screw. Verify the

trajectory of the screw by using uoroscopy. Pre-drilling

the cortex is recommended using the 3.2mm drill bit.

PediPlates®

O-PLATE, I-PLATE, DELTA

9

9

Measure and Drill for Metaphyseal Screw

Using the direct measuring device, idenfy the appropriate screw length. Drill over the 1.6mm guide wire using the

3.2mm cannulated drill bit to pre-drill for inseron of the screw. It is not necessary to drill past the cortex. The

metaphyseal screw should be about one-third of the distance across the segment of the bone.

As stated earlier, if using double drill guide with stop (01-1010-0210), advance the 3.2mm cannulated drill bit unl it

will no longer advance. This will ensure that you have only drilled the near cortex.

FIGURE 9: Metaphyseal screw inseron

10

Insert Metaphyseal Screw

Select the appropriate size of screw from the caddy. Size can be

conrmed using the scale on the screw caddy.

Insert screw over guide wire into metaphysis ensuring screw is not

ghtened completely at this stage of inseron (Figure 9). Conrm

placement of the screw using uoroscopy.

Cauon: If using non cannulated screws, be sure to remove

the guide wire before inserng the screw. Verify the

trajectory of the screw by using uoroscopy. Pre-drilling

the cortex is recommended using the 3.2mm drill bit.

PediPlates®

10

SURGICAL TECHNIQUE

11

Final Tightening

Prior to nal ghtening, remove the physeal guide wire. Complete

nal ghtening by alternavely ghtening between metaphyseal

and epiphyseal screws (Figure 10).

FIGURE 10: Final ghtening of metaphyseal and

epiphyseal screws

1

12

Closure

Close the wound.

Note: If needed, use uoroscopy to conrm plate is ush with the

bone. The screws should be fully seated and not enter the physis.

Cauon: Not removing the physeal guide wire before nal

ghtening can result in the pin fracturing and dicult

removal of the pin.

PediPlates®

O-PLATE, I-PLATE, DELTA

11

TECHNICAL TIPS

• Make sure all screws are ghtened sequenally and that the plate is adjacent to the bone. It is somemes

necessary to gently bend the plate in order to get it to t onto the bone. This is oen the case in the proximal

bia. If the plate is not adherent to the bone, addional stress may be exerted onto the screws potenally

leading to screw breakage.

• It is not necessary to drill past the cortex for placement of the screws. Simply drill the outer cortex into the

epiphysis/metaphysis with the 3.2mm drill bit. All the screws are self-tapping and are easily inserted into

epiphyseal/metaphyseal bone.

• Use cauon when using the Low Prole PediPlate Screws with PediPlate Delta. Delta allows for maximum

divergence of screws within the plate and it is possible for the Low Prole PediPlate Screws to disengage from

PediPlate Delta at maximum divergence.

• Timing of removal of implants is crical. If the implants are le in too long, overcorrecon may occur and

addional stress to the implants may occur. Overcorrecon can lead to development of a bony deformity.

Addional stress to the implants may compromise implant integrity making removal dicult. Be sure to

rounely follow paents throughout growth modulaon for signs of implant stress and fague.

PediPlates®

12

O-PLATE AND I-PLATE

Implants

Item Number Qty Descripon

4.5mm Cannulated Screws

00-1015-316 8 4.5mm x 16mm Cannulated Screw

00-1015-320 8 4.5mm x 20mm Cannulated Screw

00-1015-324 8 4.5mm x 24mm Cannulated Screw

00-1015-328 8 4.5mm x 28mm Cannulated Screw

00-1015-332 8 4.5mm x 32mm Cannulated Screw

00-1015-336 8 4.5mm x 36mm Cannulated Screw

4.5mm Low Prole Screws

00-1015-616 8 LP 4.5mm x 16mm Cannulated Screw

00-1015-620 8 LP 4.5mm x 20mm Cannulated Screw

00-1015-624 8 LP 4.5mm x 24mm Cannulated Screw

00-1015-628 8 LP 4.5mm x 28mm Cannulated Screw

00-1015-632 8 LP 4.5mm x 32mm Cannulated Screw

00-1015-636 8 LP 4.5mm x 36mm Cannulated Screw

4.5mm Solid Screws

00-1015-516 8 4.5mm x 16mm Solid Screw

00-1015-520 84.5mm x 20mm Solid Screw

00-1015-524 84.5mm x 24mm Solid Screw

00-1015-528 8 4.5mm x 28mm Solid Screw

00-1015-532 8 4.5mm x 32mm Solid Screw

00-1015-536 8 4.5mm x 36mm Solid Screw

O-Plates

00-1012-212 4 O-Plate 12mm - Center Hole

00-1012-216 4O-Plate 16mm - Center Hole

00-1012-220 4 O-Plate 20mm - Center Hole

00-1012-224 4 O-Plate 24mm - Center Hole

I-Plates

00-1015-416 2

00-1015-422 2

00-1015-432 2

I-Plate 16mm - Center Hole

I-Plate 22mm - Center Hole

I-Plate 32mm - Center Hole

PRODUCT INFORMATION

Plate Size

1.5mm

1.5mm

10mm

Plate Size

2.83

mm

2.83

mm

4.32

mm

PediPlates®

O-PLATE, I-PLATE, DELTA

13

Instrumentaon

I-PLATE AND O-PLATE

Item Number Qty Descripon

Drill and Drill Guides

01-1010-009 2AO 3.2mm Cannulated Drill

01-1010-010 1 Double Drill Guide

09-1010-010 1 Self-Centering Drill Guide

Guide Wires

01-1010-007 10 1.6mm Guide Wire, Threaded

01-1050-0039 10 1.6mm Guide Wire, Smooth (oponal)

Screwdrivers

01-1010-006 13.5mm Cannulated Hex Screwdriver, AO ng

01-1010-014 1 3.5mm Hex Screwdriver, AO ng

Bending Irons

01-1010-002 1 Bending Iron, Right

01-1010-013 1Bending Iron, Le

Miscellaneous

01-1030-009 1 Direct Measuring Device

01-1010-012 1 Depth Gauge

01-1030-001 1 Mini In-line Ratchet w/ small AO push/pull coupling

01-1010-001 1 Mini T-Handle

01-1010-003 11.7mm Cleaning Brush

01-1010-004 1 Cleaning Stylet

01-1030-007 1 Self-Holding Screw Forceps

Case and Tray

01-1010-603 1Case Boom

01-1010-604 1Case Tray

01-1010-905 1 Case Lid

01-1010-906 1 Case Screw Caddy

01-1010-951 1 PediPlate Solid Screw Caddy

01-1010-952 1 PediPlate Solid Screw Caddy Lid

PRODUCT INFORMATION

PediPlates®

14

PEDIPLATE DELTA

Item Number Qty Descripon

Delta Screws

00-1015-0716 8 4.5mm x 16mm Cannulated Screw, Delta

00-1015-0720 8 4.5mm x 20mm Cannulated Screw, Delta

00-1015-0724 8 4.5mm x 24mm Cannulated Screw, Delta

00-1015-0728 8 4.5mm x 28mm Cannulated Screw, Delta

00-1015-0732 8 4.5mm x 32mm Cannulated Screw, Delta

00-1015-0736 8 4.5mm x 36mm Cannulated Screw, Delta

Delta Plates

00-1012-0312 4 PediPlate Delta 12mm

00-1012-0316 4PediPlate Delta 16mm

00-1012-0320 4 PediPlate Delta 20mm

00-1012-0324 4 PediPlate Delta 24mm

Delta-Specic Instrumentaon

01-1010-0209 13.2mm Cannulated Drill, Delta

01-1010-0210 1 Double Drill Guide, Delta

Delta Case and Tray

01-1010-0610 1 PediPlate Delta Base

01-1010-0612 1 PediPlate Delta Case Lid

01-1010-0611 1PediPlate Delta Tray

01-1010-0615 1 PediPlate Delta Tray Lid

01-1010-0613 1 PediPlate Delta Screw Caddy

01-1010-0614 1 PediPlate Delta Screw Caddy Lid

PRODUCT INFORMATION

4.32

mm

Plate Size

1.5mm

OrthoPediatrics, Children Are Not Just Small Adults, PediPlates, PediLoc,

Scwire and the Pedi logo are registered trademarks in the United States.

The Pedi logo is a registered trademark in Australia and New Zealand,

and a registered Community Trade Mark.

OrthoPediatrics, Children Are Not Just Small Adults, ArmorLink, PediFlex,

PediFrag, PediLoc, PediNail, PediPlates, PLEO, Response, Scwire, ShieldLoc,

and the OP and Pedi logos are trademarks of OrthoPediatrics Corp.

This technique has been provided by one of our

medical advisors only as guidance and it is not

intended to limit the methods used by trained

and experienced surgeons.

Federal law restricts this device to sale by or

the order of a Physician.

Devices are supplied Non-Sterile. Clean and

sterilize before use according to instrucons.

Implants components are single-use. Do not

reuse.

The device is not approved for screw

aachment or xaon to the posterior

elements (pedicles) of the cervical,

thoracic or lumbar spine

Only those instruments and implants contained

within this system are recommended for

use with this technique. Other instruments

or implants used in combinaon or in place

of those contained within this system is not

recommended.

This document is intended exclusively for experts in the eld, i.e. physicians in

parcular, and expressly not for the informaon of laypersons.

The informaon on the products and/or procedures contained in this document

in of general nature and does not represent medical advice or recommendaons.

Since this informaon does not constute any diagnosc or therapeuc statement

with regard to any individual medical case, individual examinaon and advising

of the respecve paent are absolutely necessary and are not replaced by this

document in whole or in part.

The informaon contained in this document was gathered and compiled by

medical experts and qualied OrthoPediatrics employees to the best of their

knowledge. The greatest care was taken to ensure the accuracy and ease

of the understanding of the informaon used and presented.

OrthoPediatrics does not assume any liability, however, for the meliness,

accuracy, completeness or quality of the informaon and excludes any liability for

tangible or intangible losses that may be causes by the used of this informaon.

NOTE:

CAUTION:

CAUTION:

CAUTION:

CAUTION:

CAUTION:

Instrucons For Use (IFU), cleaning instrucons, and surgical

techniques may be obtained by calling OrthoPediatrics®

Customer Service at 574-268-6379. Read and understand indicaons,

warnings, and adverse eects explained in IFU's prior to use.

2850 Froner Drive • Warsaw, IN 46582 • ph: 574.268.6379 or 877.268.6339 • fax: 574.268.6302 • www.OrthoPediatrics.com

OrthoPediatrics Corp. ©2015 ST-1010-01-01 Rev C