Foot And Ankle Biologic Solutions 1

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Bone Graft Substitutes

Soft Tissue Repair

Foot & Ankle

Midfoot

Rearfoot

Forefoot

Ankle

Foot & Ankle

Vitoss

Vitoss is the #1 selling Synthetic Bone Gra for one

good reason... IT WORKS.1

Human clinical data supports its ecacy2—over 425,000

implantations worldwide.3

Vitoss BA has a unique porosity, bioactivity, and

chemistry. Literature shows that bioactive glass stimulates

osteoblastic activity and facilitates bone formation in

in-vitro and animal models.4-6 Upon implantation, the

ionic constituents (Si+, Na+, Ca2+) of bioactive glass are

released into the surrounding environment and react with

the bodily uids.7-10 is reaction produces the deposition

of a thin layer of physiologic calcium phosphate at its

surface, favorable for osteoblast attachment.11 is is

commonly referred to as an osteostimulatory eect.4-6, 9, 12-14

In a direct comparison animal study, glass demonstrated

accelerated healing when bioactive glass was added to an

osteoconductive scaold.15

HydroSet

HydroSet is a calcium phosphate cement that converts to

hydroxyapatite, the principle mineral component of bone.

It is injectable, sculptable and fast setting.

HydroSet can be drilled and tapped to accommodate

the placement of provisional hardware during the surgical

procedure.

Specically formulated to set in a wet eld environment,

HydroSet exhibits outstanding wet-eld characteristics.16

MemoDerm

MemoDerm is a sterile acellular dermal matrix derived from

human allogra skin tissue, specically designed to play a key

role in the revascularization and repopulation of cells.

e unique processing method removes the epidermal layer

and dermal cells, minimizing the potential for an immunogenic

response.

TissueMend

By combining physical properties of strength and thickness

with biologic properties that encourage cell and blood vessel

penetration, the TissueMend collagen matrix is designed to

handle the vigorous demands of tendon repair.

Over time, normal tissue remodeling occurs where TissueMend

is incorporated into the native tissue and ultimately replaced by

natural, healthy, native cells and tissue.

PriMatrix

PriMatrix is an acellular collagen matrix that provides an

environment to support cell repopulation and revascularization

during the wound healing process.

PriMatrix uses a proprietary process designed to remove

cellular components and potentially infectious agents from

raw material, while preserving the biological properties and

structure of native collagen.

PriMatrix can be cut into strips to eciently ll deep or

tunneled wounds.

4 | Bone and Tissue

Foam Pack

Vitoss Foam Pack is a versatile material that is

stable in a uid environment, can soak and hold

bone marrow, and is compression-resistant.

Foam Strip

Vitoss Foam Strip is a compression-resistant, pre-

formed strip that is exible when wet, can soak

and hold bone marrow, and is easily customized

for various graing applications.

Morsels

Vitoss Morsels are an economical way to provide a

quality synthetic product to your patients for large

volume graing applications. Vitoss Morsels oer

a cost comparative option to allogra chips.

Canisters

Vitoss Canisters oer the handling and delivery

of Vitoss Morsels with the use of bone marrow

aspirate or blood. It is a closed system designed

to minimize handling and exposure to potential

contaminants.

Vitoss Products

Vitoss BA features a combination of porosity, structure, bioactivity

and chemistry. As a calcium phosphate that is up is to 90% porous17,

Vitoss’s interconnected porosity allows for 3-D regeneration of bone,

as opposed to creeping substitution. e increased porosity has been

shown to lead to higher fusion rates in an animal study.18

Literature shows that bioactive glass stimulates osteoblastic activity

and facilitates bone formation in in-vitro and animal models.4-6 Upon

implantation, the ionic constituents (Si+, Na+, Ca2+) of bioactive

glass are released into the surrounding environment and react with

the bodily uids.7-10 is reaction produces the deposition of a

thin layer of physiologic calcium phosphate at its surface, favorable

for osteoblast attachment.11 is is commonly referred to as an

osteostimulatory eect.4-6, 9, 12-14 In a direct comparison animal study,

glass demonstrated accelerated healing when bioactive glass was

added to an osteoconductive scaold.15

Chemistry aects the rate of resorption. Bone gras should resorb as

new bone forms in a physiologic time frame. Vitoss is composed of

β-TCP and is stable at physiologic pH. It resorbs during the natural

remodeling process of bone.

Stryker Foot & Ankle | 5

Product Specifications

Chemical Composition

Powder: Dicalcium phosphate dihydrate, Tetracalcium

phosphate and Tri-sodium citrate

Liquid: Sodium phosphate, Polyvinylpyrrolidone and water

Packaging Contains: Bowl of powder, Liquid-lled syringe,

Delivery syringe, Cannula and spatula.

Shelf Life: 1 year Sterilization: Ethelyne oxide and

Gamma irradiation

Imbibe is a system of disposable bone

marrow aspiration devices. e Imbibe

bone marrow aspiration needles

provide a minimally invasive way to

harvest bone marrow. e needles

come with both bullet-tip and sharp-

trocar stylets, which are color coded.

Bone marrow aspirate harvested using

Imbibe bone marrow aspirate syringes

can then be used to rehydrate Vitoss.

®

HydroSet is a self-setting calcium phosphate cement

indicated to ll bony voids or gaps of the skeletal

system—extremities, craniofacial, spine, and pelvis.

HydroSet is indicated only for bony voids or gaps that

are not intrinsic to the stability of the bony structure.

HydroSet cured in situ provides an open void/gap

ller than can augment provisional hardware—

K-Wires, plates, screws—to help support bone

fragments during the surgical procedure. e

cured cement acts only as a temporary support

media and is not intended to provide structural

support during the healing process.

HydroSet can be easily implanted via simple

injection or manual application techniques for a

variety of applications. It is specically designed

to set quickly once implanted under normal

physiological conditions. HydroSet does not

release any heat as it sets, preventing potential

thermal injury.

 • HydroSetischemicallyformulatedtosetina

wet eld environment,16 eliminating the need

to meticulously dry the operative site prior

to implantation.

 • ecompositionofhydroxyapititeclosely

matches that of bone mineral, thus imparting

osteoconductive properties.20

 • HydroSetcanbedrilledandtappedto

accommodate the placement of provisional

hardware during the surgical procedure.

3 Weeks 6 Weeks 12 Weeks 24 Weeks 52 Weeks

Bone Vitoss Other Scaffolds

Iliac Crest (PSIS, ASIS)

Calcaneus

Vitoss

Comparison of Vitoss to competitive gra in a canine metaphyseal study

in order to radiologically compare healing at 3, 6, 12, 24, and 52 weeks.

A 10mm x 22mm drill defect was created in the canine proximal

humerus and lled with 2cc of bone gra.19

Materials with interconnected porosity will allow for 3-D regeneration

of bone as opposed to creeping substitution. Vitoss is a highly porous

calcium-phosphate (up to 90% porous).17 Additionally, increased porosity

has been shown to lead to higher fusion rates in an animal model.18

Not All Scaffolds are Created Equal

Porosity

HydroSet®

Injectable HA Bone Substitute

Competitive

Graft

6 | Bone and Tissue

e TissueMend So Tissue Repair Matrix is an acellular, collagen

membrane used to repair and reinforce so tissues where weakness exists.

A unique collagen composition and structure makes TissueMend an

excellent biologically inspired scaold for tissue remodeling. Non-artical

cross-linking helps to provide a medium for normal cellular growth and

maturity, allowing for the development of new, healthy tissue.

When implanted, TissueMend provides an environment where host cells

and supporting vasculature can take up residence and mature. Over time,

normal tissue remodeling occurs where TissueMend is incorporated into the

native tissue and ultimately replaced by native collagen bers.

As a direct result of its technologically advanced production process,

the TissueMend So Tissue Repair Matrix has demonstrated a lack of

inammation and foreign body reaction when implanted into native tissue.21

 • Composedof99%pure,non-denaturedcollagen

 • Availableasarectangularpatchwithdimensionsof

3cm x 3cm, 5cm x 6cm, or 6cm x 10cm

 • Asaresultofitsthickness,externalforcesaredistributed

over a greater surface area

 • Canbeeasilycutandtrimmedbothbeforeandaer

gra hydration

 • Hydratesinseconds

 • Non-crosslinked

 • RichinTypeIIICollagen

 • Potentialforreducedscarring22

Host fibroblasts have

migrated into and populated

TissueMend beginning the

remodeling process.

Note the lack of foreign body

reaction to TissueMend.

Inflammatory cells are absent

and the implant has not been

encapsulated.

Three month rat intramuscular

biocompatibility evaluation

Stryker Foot & Ankle | 7

PriMatrix

PriMatrix is an acellular collagen matrix derived from fetal bovine

dermis. is biologic matrix helps provide an environment to

support the cell repopulation and revascularization process

essential to wound healing. In addition to non-denatured Type I

collagen, PriMatrix is rich in Type III collagen, which is active in

developing and healing tissues. e product delivers this unique

fetal collagen composition and architecture into the wound bed.

PriMatrix uses a proprietary process designed to remove cellular

components and potentially infectious agents from raw material,

while preserving the biological properties and structure of

native collagen.

PriMatrix is oered in a variety of sizes and congurations; large

and small pieces may be applied. PriMatrix can be cut into strips

to eciently ll deep or tunneled wounds. All congurations

of PriMatrix may be used in conjunction with vacuum-assisted

wound healing systems.

 • Availableinbothfenestratedandnon-fenestratedversions

 • ree-yearshelflife

 • Biocompatibleandcell-friendlywithnoarticial

chemical crosslinking

 • Terminallysterilized

Providing an Environment to Manage Wound Healing

MemoDerm Acellular Dermal Matrix is derived from

human allogra skin tissue that is terminally sterilized.

e unique processing method removes the epidermal and

dermal cells, minimizing the potential for an immunogenic

response. e resulting acellular dermal matrix has the

natural histomorphology preserved.

MemoDerm is specically designed to play a key role in the

revascularization and repopulation of cells. e proprietary

gamma irradiation sterilization process does not damage the

matrix. e cellular elements, typically considered

immunogenic, are absent.

 • ProprietaryGammaPrecisionDoseSterilizationprocess

provides a Sterility Assurance Level (SAL) of 10-6

 • ExcellentTensileStrength

 • ExcellentSutureRetentionStrength

 • Indicatedfortherepairorreplacementofdamagedor

inadequate integumental tissue. Note - meshed MemoDerm

is to be used for wound care only (burns, ulcers)

e RegenKit THT is designed to be used for the safe and

rapid preparation of autologous platelet-rich plasma (A-PRP)

from a small sample of blood at the patient’s point of care.

Aer the simple 4-step preparation, the A-PRP can be applied

to an orthopedic surgical site, as deemed necessary by clinical

use requirements.

Features and Potential Benets

 • Simplicity

 • Lowbloodvolumerequired

 • Optimumplateletrecovery23

 • Consistentisolationof

platelet concentrate

and plasma23

 • Leukocytesat

physiological levels23

 • Erythrocytedepletion23

Non-Meshed

Meshed

PriMatrix™

Dermal Repair Matrix

®

Joint Replacements

Trauma & Extremities

Craniomaxillofacial

Spine

Biologics

Surgical Products

Neuro & ENT

Interventional Spine

Navigation

Endoscopy

Communications

Imaging

Patient Care & Handling Equipment

EMS Equipment

Distributed by:

Stryker

325 Corporate Drive

Mahwah, NJ 07430

t: 201 831 5000

www.stryker.com

Vitoss is manufactured by:

Stryker Orthobiologics

77 Great Valley Parkway

Malvern, PA 19355

Vitoss

Foam pack - Also available in Vitoss BA2X** / BA*

1.2cc ...........................**2102-2101

*2102-1601, 2102-1401

2.5cc ...........................**2102-2102

*2102-1602, 2102-1402

5cc... ...........................**2102-2105

*2102-1605, 2102-1405

10cc ............................**2102-2110

*2102-1610, 2102-1410

Foam Strip - Also available in Vitoss BA*

25 x 100 x 4mm - 10cc *2102-1500

25 x 100 x 4mm - 10cc.. 2102-1100

25 x 100 x 8mm - 20cc *2102-1520

25 x 100 x 8mm - 20cc.. 2102-1120

25 x 240 x 4mm - 24cc.. 2102-1101

25 x 50 x 4mm - 5cc ..... *2102-1505

25 x 50 x 4mm - 5cc ...... 2102-1105

25 x 50 x 8mm - 10cc ... *2102-1510

25 x 50 x 8mm - 10cc .... 2102-1110

75 x 100 x 4mm - 30cc.. 2102-1130

Morsels

15cc Macro .................... 2102-0020

30cc Macro .................... 2102-0021

1.2cc Blocks .................. 2102-0013

10cc Blocks ................... 2102-0006

30cc Macro (x10) ........... 2102-0131

Canisters

5cc Micro ....................... 2102-0026

5cc Standard ................. 2102-0030

10cc Micro ..................... 2102-0027

10cc Standard ................ 2102-0031

15cc Micro ..................... 2102-0028

15cc Standard ................ 2102-0032

30cc Micro ..................... 2102-0029

30cc Standard ................ 2102-0033

Imbibe

Syringes

10cc .............................. 2105-0010

20cc .............................. 2105-0020

30cc .............................. 2105-0030

Needles

11 gauge x 4in ............... 2090-0027

11 gauge x 6in ............... 2090-0028

8 gauge x 6in ................. 2090-0029

8 gauge x 8in ................. 2090-0047

Fenestrated

8 gauge x 6in ................. 2090-0030

TissueMend

5cm x 6cm .................... 6495-9-001

6cm x 10cm .................. 6495-9-004

3cm x 3cm .................... 6495-9-006

MemoDerm

Non-Meshed

2cm x 4cm (0.33-0.61mm thickness)

HTM0330204

4cm x 8cm (0.80-1.40mm thickness)

HTM0800408

5cm x 5cm (0.80-1.20mm thickness)

HTM0900505

5cm x 5cm (1.00-2.00mm thickness)

HTM1500505

5cm x 10cm (2.00-3.50mm thickness)

HTM2000510

Meshed

4cm x 4cm (0.40-0.80mm thickness)

HTM0400404M

4cm x 8cm (0.40-0.80mm thickness

HTM0400408M

RegenKit THT

RegenKit THT ................ 8495-9-001

Universal Centrifuge ....... 8495-9-010

Balancing Tube 3Pk ....... 8495-9-998

PriMatrix

4cm x 4cm .................... 6495-9-104

6cm x 6cm .................... 6495-9-106

8cm x 8cm .................... 6495-9-108

4cm x 4cm Fenestrated . 6495-9-114

6cm x 6cm Fenestrated . 6495-9-116

8cm x 8cm Fenestrated . 6495-9-118

1. Millennium Research Group: US Markets for Orthopedic

Biomaterials

2. Vitoss Bibliography, P/N 5606-011 7 Rev. 00, 2010.

3. Stryker Orthobiologics Internal Sales Data, May 2012.

4. Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at

the Interface of Ceramic Prosthetic Materials. Journal of Biomedical

Materials Research, 1971; 2(1): 117-141.

5. Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive

Glass-Ceramic Materials to Bone and Muscle.Journal of Biomedical

Materials Research, 1973; 4: 25-42.

6. Gross, U., e Interface of Various Glasses and Glass Ceramics with a

Bony Implantation Bed. Journal of Biomedical Materials Research,

1985; 19: 251-271.

7. Hench, L.L., e Story of Bioglass. Journal of Materials Science:

Materials in Medicine, 2006 Nov; 17(11): 967-78.

8. Oonishi, H., et al., Particulate Bioglass Compared with

Hydroxyapatite as a Bone Gra Substitute. Clinical Orthopaedics

and Related Research, 1997 Jan; 334: 316-25.

9. Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of

Osteoblasts Cultured on Bioactive Glass, Hydroxyapatite, Titanium

Alloy, and Stainless Steel. Journal of Biomedical Materials Research,

1993 Apr; 27(4): 465-75.

10. Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M.,

Ionic Products of Bioactive Glass Dissolution Increase Proliferation

of Human Osteoblasts and Induce Insulin-like Growth Factor

II mRNA Expression and Protein Synthesis. Biochemical and

Biophysical Research Communications, 2000 September 24; 276(2):

461-5.

11. Hench, L.L., Polak, J.M., Xynos, I.D., Buttery, L.D.K., Bioactive

Materials to Control Cell Cycle. Materials Research Innovations,

2000; 3(6): 313-323.

12. Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal

of American Ceramic Society. 1973; 56(7): 373-377.

13. Hench, L.L., Characterization of Glass Corrosion and Durability.

Journal of Non-Crystalline Solids, 1975; 19: 27-39.

14. Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on

Silicate Glasses. Journal of Non-Crystalline Solids, 1980; 38 and 39:

673-678. Spinal Fusion Model. European Spine Journal, 2007; 16:

2215-2224.

15. Havener, M.B., Brown, L.S., Darmoc, M.M., Owsianny, R.S.,

Cline, T.D,, Improvements in Healing with a Bioactive Bone Gra

Substitute in a Canine Metaphyseal Defect. 55th Annual Meeting of

the Orthopaedic Research Society, 2009.

16. 1808.E703

17. Orthovita Test Report P/N 1070-0008R.

18. Motomiya, M., et al., Eect of Hydroxyapatite Porous Characteristics

on Healing Outcomes in Rabbit Posterolateral Spinal Fusion Model.

European Spine Journal, 2007; 16: 2215-2224.

19. Havener, MB, Cline, TD, Darmoc, MM, Brown, LS, Owsiany, R, A

Comparative Study of Synthetic Bone Gra Substitutes in a Canine

Metaphyseal Defect. 54th Annual Meeting of the Orthopaedic

Research Society, 2008.

20. Dikson, K.F., et al. e Use of BoneSource Hydroxyapatite Cement

for Traumatic Metaphyseal Bone Void Filling. J Trauma 2002;

53:1103-1108.

21. Zerris,V., et al., Repair of the dura mater with processed collagen

devices. Journal of Biomedical Materials Research Part B: Applied

Biomaterials, 2007. 83(2): p. 580-8.

22. Larson et al. “Scarless Fetal Wound Healing: A Basic Science

Review” Plastic and Reconstructive Surgery 126(4) 1172-1180,

2010.)

23. Study Report – Regen™ THT Tube Performance Testing, USFDA

510(k) BK090048, May 2010, Data on le at RegenLab, Switzerland

DESCRIPTION ................... PART NUMBER

References:

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a

particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before

usingitinsurgery.•einformationpresentedisintendedtodemonstratethebreadthofStrykerproductoerings.Asurgeonmustalwaysreferto

the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because

product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have

questionsabouttheavailabilityofStrykerproductsinyourarea.•Caution:Federallawrestricsthisdevicetosalebyorontheorderofaphysician.

Foradditionalsafetyinformation,pleaseseetheVitossProductInstructionsforUse.•StrykerCorporationoritsdivisionsorothercorporate

aliated entities own, use or have applied for the following trademarks or service marks: HydroSet, Imbibe, MemoDerm, Stryker, Vitoss. All other

trademarks are trademarks of their respective owners or holders. Lit.#NL12-BR-JP-581 Copyright ® 2012 Stryker