Spine

The newest member ofthe #1 selling

synthetic bone graft family1

Enhance bioactivity through bimodal technology development

Vitoss BiModal features:

Vitoss BiModal

50 100

0320 0 3290 90150 150

0

Per

cent

Com

posi

tion

by M

ass

(%)

Bioactive Glass Particle Size (μm)

Vitoss BA / Vitoss BA2X

Bioactive Glass Particle Size (μm)

An ultraporous, open inter-connected structure which guides the 3-dimensional regeneration of bone2

Bimodal bioactive glass particles which promote the deposition of calcium phosphate on the implant surface3

A broader range of particle distribution leading to an increased surface area of bioactive glass and both an immediate burst and sustained release of Ca2+, Na+, and Si+ ions4

··

·

VitossBiModal_SalesSheet_010913.indd 1 1/9/2013 3:51:12 PM

Increased calcium phosphate deposition with Vitoss BiModal*

Vitoss + Bone Marrow Aspirate (BMA)resembles Iliac Crest Bone Graft (ICBG),the gold standard, in that it has the samethree components: scaffold,cells, and signal.5

Greater Initial BurstThe 32-90 µm bioactive glass particles kickstart the Ca2+, Na+,and Si+ ion release. Bioactive glass leads to a gel-like surfacelayer that mineralizes and promotes the deposition of calciumphosphate on the implant surface favorable for osteoblastattachment and bone formation.4,6

1 - Millennium Research Group: US Markets for Orthopedic Biomaterials, 2010. 2 - Orthovita Test Report P/N 1050-0003R. 3 - Orthovita Test Report P/N 1010-0117R. 4 - Orthovita Test Report P/N 1015-0083R. 5 - Bellincampi, L., Clineff, T., Erbe, E., Osteoinductivity of VitossTM with Isologous Bone Marrow in Urist Rat Pouch Model. Society for Biomaterials, Tampa FL, April 24-27, 2002(Podium). 6 - Hench, L.L., Polak, J.M., Xynos, I.D., Buttery, L.D.K., Bioactive Materials to Control Cell Cycle. Materials Research Inovations, 3: 313-23, (2000). 7 - Erbe, E.M., Clinef, T.D., Marx, J.G.,Use of a New Ultraporous Beta-Tricalcium Phosphate Cancellous Bone Void Filler. Annual Meeting of the American Association of Neurological Surgeons (2001).* - As shown in in-vitro studies** - The bioactive response of Vitoss BiModal has not been assessed in any animal study or clinical investigation and the results from laboratory testing may not be predictive of human clinical experience.

Important Safety Information: - Vitoss BiModal Bioactive Bone Graft Substitute is contraindicated in the presence of one or more of the following clinical situations: growth plate fractures, segmental defects, conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware, significant vascular impairment proximal to the graft site, metabolic or systemic bone disorders that affect bone or wound healing, infected sites, osteomyelitis at the operative site, defect site stabilization is not possible, intraoperative soft tissue coverage is not planned or possible, in direct contact with the articular space, and conditions in which general bone grafting is not advisable. - Vitoss BiModal must not be used in patients with a history of anaphylaxis, history of multiple allergies, known allergies to bovine collagen, or who are being treated for desensitization to meat products because this product contains bovine collagen. - Vitoss BiModal Bioactive Bone Graft Substitute does not possess sufficient mechanical strength to support reduction of a defect site. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all planes. Vitoss BiModal cannot be used to obtain purchase for screws. Screws must gain purchase in the host bone. - Complete postoperative wound closure is essential. Vitoss BiModal must not be used to repair bone defects where soft tissue coverage cannot be achieved. - Vitoss BiModal is intended for use by surgeons familiar with bone grafting and rigid fixation techniques. - Vitoss BiModal’s radiopacity is comparable to that of bone and diminishes as it is resorbed. This moderate radiopacity may mask underlying pathological conditions and must be considered when evaluating X-rays. - Vitoss BiModal should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. - Care should be exercised when using Vitoss BiModal not to over-fill the defect site.Vitoss BiModal Bioactive Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.

Vitoss BiModal is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BiModalBioactive Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) andmay be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with boneduring the healing process.

The osteostimulatory effects of Vitoss Bioactive have not been correlated to human clinical experience.

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. The informationpresented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or user instruc-tions before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practicesthat govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Stryker, Vitoss.All other trademarks are trademarks of their respective owners or holders.

Literature Number: 5701-0096 Rev.00AQ/LW 10/12

Copyright © 2013 Stryker

Manufactured by:Orthovita, Inc.45 Great Valley ParkwayMalvern, PA 19355 USAt: 800-774-8870f: 610-640-2603

Distributed by:Stryker Spine2 Pearl CourtAllendale, NJ 07401 USAt: 201-760-8000

www.stryker.com

Ordering Information:Vitoss BiModal 1.2cc (2102-1901) Vitoss BiModal 2.5cc (2102-1902)Vitoss BiModal 5cc (2102-1905) Vitoss BiModal 10cc (2102-1910)

Sustained Release**In-vitro and animal studies have shown upon contact with bodily fluid,combeite bioactive glass particles:

· Release ions into the immediate environment6

· Induce deposition of calcium phosphate on the implant6

· Attract osteoblasts to the scaffold surface6

· Create a surface favorable to bone formation6

Vitoss and BMA

scaffold

cells

signalRelative Calcium Deposition Between Vitoss Products3,*

Ca2+, Na+, Si+ Ion Release Profile4

BA in Vitoss BiModal = increased surface area = increased ions

at 14 Days

25

20

15

10

5

0

2000

1600

1200

800

400

0

No Glass

Rel

ativ

e C

alci

um D

epos

ition

inR

espo

nse

to B

ioac

tive

Gla

ss

Ca2+

, Na+

, Si+

Ion

Con

cent

ratio

n (p

pm)

Vitoss BA

(32-90µm)+(90-150µm)

(90-150µm)

0 5 10 15Time (Days)

20

Vitoss BA2X Vitoss BiModal

Vitoss structure7

Vitoss BiModal:varied particle size3

Vitoss BiModal:increased mineralization3

VitossBiModal_SalesSheet_010913.indd 2 1/9/2013 3:51:14 PM