Puros Demineralized Bone Matrix (DBM) ® DBM with Reverse Phase Medium (RPM) – Putty, Putty with Chips, Gel and Paste DBM – Block and Strip Puros DBM Block Puros DBM Strip Puros DBM with RPM Putty Puros DBM with RPM Putty with Chips Puros DBM with RPM Gel Puros DBM with RPM Paste Safe and effective bone graft substitutes to stimulate natural bone formation processes Used alone or as a bone graft extender, Puros DBM allografts provide osteoconductive and osteoinductive properties, superior handling and excellent graft containment in a ready to use application. Puros ® Demineralized Bone Matrix Block and Strip Puros Demineralized Bone Matrix (DBM) Block and Strip are unique bone graft substitutes composed of 100% demineralized cancellous bone. Puros DBM Block and Strip cancellous bone allografts are ideal natural scaffolds for new bone growth because they are processed to retain osteoinductive properties by preserving endogenous growth factors including BMP 2, BMP 4 and BMP 7 to help support new bone formation.1 Puros DBM Block and Strip are available in a variety of configurations to minimize the need for shaping during the surgical procedure, and are conveniently provided sterile with up to five year shelf life at room temperature. Puros DBM Block and Strip Product Attributes: • Osteoconductive • O steoinductive properties including endogenous growth factors BMP 2, BMP 4 and BMP 7 to help stimulate new bone formation1 • D emineralized cancellous bone – no carrier or binding agent Puros DBM Strip used with Trabecular Metal™ Material, TM-400 Device • A vailable in a variety of sizes and shapes to reduce transplant preparation • Flexible and compressible once wetted Excellent blood wicking capabilities (after minimal preparation) 1. Shi Y., Dittman B., Atkinson B. (2011) Bone Morphogenic Protein (BMP) Content in Cancellous Bone: A Suitable Substrate For Allograft Stem Cells. AlloSource Scientific Data Series 4, 3. Puros ® Demineralized Bone Matrix with Reverse Phase Medium Putty and Putty with Chips Puros Demineralized Bone Matrix with Reverse Phase Medium (DBM with RPM) Putty, Putty with Chips, Gel and Paste are unique bone graft substitutes composed of demineralized bone matrix in a reverse phase medium. Puros DBM with RPM products are designed to stimulate natural bone formation processes, in which mesenchymal cells differentiate into bone-forming cells. Because the reverse phase medium becomes more viscous at warm temperatures, it allows the allograft to be malleable at operating room temperatures, but causes the product to stiffen when placed in the operative site. Thus, the DBM is contained at the surgical site with minimal loss through irrigation and suction. Variability in allograft tissue is always a concern as no two donors are alike, which is why Zimmer utilizes a highly regarded in-vivo test to confirm osteoinductive potential of every lot ensuring the ability to grow new bone. Additionally, all lots are tested for osteoinductive potential after sterilization. Puros DBM with RPM Putty and Putty with Chips Product Attributes: • Provides excellent source of OI material for fusions • Safe and regulated • Superior handling and graft containment • More viscous at body temperature • Resists irrigation • Lot tested for OI potential after sterilization Resists irrigation Puros DBM with RPM Putty with Chips contains (850 microns to 4mm) cancellous bone chips. Puros ® Demineralized Bone Matrix with Reverse Phase Medium Gel and Paste with Cancellous Bone Puros DBM with RPM Gel and Paste Product Attributes: • E nhances flow through carrier syringe to fusion site • Easily molded to desired shape • Will not stick to surgical gloves • Hardens at body temperature • Remains in surgical site • Resists irrigation Puros DBM with RPM Paste contains added ground cancellous bone (<500 microns) to provide additional structural properties for bone growth. Autograft Why Use Puros DBM with RPM? Pre-clinical evidence suggests that Puros DBM with RPM Gel may provide a suitable alternative to autograft for routine bone grafting procedures, and facilitate fusion with normal bone.2, 3 6 weeks 12 weeks 26 weeks AlloFuse®* Radiographs show bone formation at the 12 and 26 week time points for both the autograft and DBM specimen 2 6 weeks 12 weeks 26 weeks * Puros DBM with RPM is a product that is comprised of the same components and formulation as AlloFuse. 2. Russel, N., Walsh, W.R., Oliver, Y., Bell, D.J., and Pak, P. Demineralized Bone Matrix Provides Equivalent Results to Autograft in Standard Posterolateral Fusion Model in Adult Rabbits. Zimmer Spine white paper, ZS-SA0799 Rev. A (11/13). 3. Coetzee, J., Use of Demineralized Bone Matrix Gel in Foot Surgery: A Prospective Randomized Controlled Study Comparing Demineralized Bone Matrix to Autologous Bone Graft. Zimmer Spine white paper, ZS-SA0800 Rev. A (11/13). Puros DBM Block and Strip Puros DBM with RPM Putty and Putty with Chips Puros DBM with RPM Gel and Paste with Cancellous Bone Item Number Description Item Number Description Item Number Description 61515012 Block, 12mm x 12mm x 12mm 84038001 Putty, 1.0cc 84138001 Gel, 1.0cc 61515014 Block, 14mm x 14mm x 14mm 84038002 Putty, 2.5cc 84138005 Gel, 5.0cc 61615154 Strip, 15mm x 40mm x 3 - 6mm 84038005 Putty, 5.0cc 84138010 Gel, 10.0cc 61615251 Strip, 20mm x 50mm x 3 - 6mm 84038010 Putty, 10.0cc 84238001 Paste with Cancellous, 1.0cc 61615205 Strip, 20mm x 50mm x 3 - 6mm (2 pack) 84338005 Putty with Chips, 5.0cc 84238003 Paste with Cancellous, 3.0cc 84338010 Putty with Chips, 10.0cc 84238008 Paste with Cancellous, 8.0cc 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. 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 Manufactured by: AlloSource 6278 South Troy Circle Centennial, CO 80111 800.557.35870559 zimmerspine.com AlloFuse is a registered trademark of AlloSource. ZS-SA0796 Rev. B (851S-1007-00) © 2014 Zimmer Spine, Inc. (01/14)