Vitoss® BBTrauma®

Bioactive Bone Graft Substitute

Vitoss BBTrauma provides a scaffold, bioactivity, cells, and signals to the bone repair site when hydrated with the patient’s own bone marrow aspirate.

Ultra-porous scaffold supports bone regeneration.1,2

Bioactive glass creates a favorable environment for bone regeneration.3,4,8

Cell and signals facilitate bone regeneration.5,8

Ordering informationVitoss BBTrauma is available in foam pack form in the following sizes:

The Imbibe needle is available in several lengths and diameters. An option with multiple distal fenestrations is also available.

Ref # Item description2102-2201 1.2cc

2102-2202 2.5cc

2102-2205 5cc

2102-2210 10cc

Vitoss BBTraumaBioactive bone graft substitute

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 information presented is intended to demonstrate the breadth of Stryker product offerings. 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 restricts this device to sale by or on order of a physician. • Indications for Use: Vitoss BBTrauma 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 BBTrauma is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BBTrauma 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) and may be combined with autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. The Imbibe Bone Marrow Aspiration Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler. • Safety/Risk Information: The use of Vitoss BBTrauma 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, conditions in which general bone grafting is not advisable. Vitoss BBTrauma 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. The Imbibe Bone Marrow Aspiration Needle is intended for use only by a licensed physician. The physician should be familiar with contraindications of performing a bone marrow aspiration procedure. Physician’s judgment is required to consider patient’s risk factors such as anticoagulant therapy or clotting disorders, prior to aspirating bone marrow.

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

Content ID: BIVIT-SS-4_13355 Copyright © 2017 Stryker Printed in USA

StructureThe highly porous, open interconnected scaffold allows for 3-D regeneration of new bone through the graft. The scaffold is composed of betatricalcium phosphate which resorbs at the relevant time frame during the bone repair process.1,2

BioactivityDuring in vitro testing, BBTrauma formulations demonstrated evidence of cell proliferation and enhanced osteogenic activity compared to controls.7,8

Imbibe® bone marrow aspiration needleCells and signals Hydrating Vitoss with autologous bone marrow aspirate provides a source of osteogenic cells and inductive signals.5,6

Ref # Item description2090-9027 11 gauge x 4 inch

2090-9028 11 gauge x 6 inch

2090-9029 8 gauge x 6 inch

2090-9030Fenestrated, 8 gauge x 6 inch

1. Stryker Test Report P/N 1070-0008R. 2. Anker et al. CORR 2005; 434: 251-7. 3. Havener M, et al. ORS 2009. Poster 508. 4. Reza A, et al. ORS 2015, Poster 1163. 5. Erbe E, et al. Eur Spine J 2001; 10:S141-6. 6. Stryker Test Report P/N 1050-0018., 7. Stryker Test Report P/N 1015-0101. 8. The osteostimulatory effects of Vitoss Bioactive have not been correlated to human clinical experience.

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