Puros®-S and Puros®-S2 Cervical Interbody Allograft Implants
Sterile-packed Puros-S and Puros-S2 allow surgeons to select from either one-piece cortical grafts or reinforced cortical and cancellous combination grafts.
Compatibility
HIGHRIDGE Spine’s Puros cervical allografts give surgeons the power to choose. Sterile-packed Puros-S and Puros-S2 allow surgeons to select from either one-piece cortical grafts or reinforced cortical and cancellous combination grafts.
The Puros family delivers the shapes, sizes and angles to fit varying patient anatomies, as well as best-in-class features designed to facilitate insertion, minimize migration and resist pullout. All Puros products work with versatile instrumentation that simplifies implantation and improves ease of use.
System Features
Strength
- Puros-S features the strength of all-cortical bone, while Puros-S2 features cortical bone with an osteoconductive cancellous center.
- Both Puros-S and Puros-S2 meet stringent quality standards that meet all U.S. Food and Drug Administration donor screening and testing requirements.
Adaptability
- With three footprints, two geometric options and five heights, Puros-S and Puros-S2 are designed for varying patient anatomies
- Between Puros-S and Puros-S2, surgeons can choose between a cortical or cortical-cancellous implant to best suit patient needs and surgeon preference.
Validation
- Puros constructs are sterilized using RTI Surgical’s proprietary BioCleanse® Tissue Sterilization Process*
- Sterilization process has been proven to inactivate or remove pathogens while preserving the biomechanical integrity of the graft
- Puros implants must pass stringent donor screening
Related Products
HIGHRIDGE Spine utilizes its deep industry knowledge and expertise to refine a comprehensive anterior cervical product portfolio of next generation devices.
Resources
Brochures
Additional Information
References
- 1. Lee MJ, Bazaz R, Furey CG, Yoo J. Influence of anterior cervical plate design on dysphagia: a 2-year prospective longitudinal follow-up study. J Spinal Disord Tech. 2005;18(5):406–9.
Legal Manufacturer
Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminster, CO 80021 USA
Important Information
Description
Description
This package contains donated human tissue intended for transplantation. Puros products are manufactured from human bone that has been through the BioCleanse® process and terminally sterilized. This product is restricted to homologous use for the repair, replacement or reconstruction of musculoskeletal defects by a qualified healthcare professional (i.e., physician).
Warnings
Warnings:
- Once opened, the graft must be used for the current procedure or discarded. Product is a single patient, single use product.
- Do not use damaged, contaminated or expired product.
- This product has been sterilized; do not re-sterilize.
- Manipulation or alterations made to a pre-shaped or assembled graft can cause graft failure.
- Do not use any tool that would result in concentrated pressure or force to the cancellous bone area of the graft, if applicable.
- Tools used for impaction should distribute pressure evenly across the cortical area(s).
- Inadequate hydration may result in graft damage upon impaction.
- Inappropriate placement and/or fixation could lead to graft migration or could adversely affect performance over time.
- Prior to performing surgery, the surgeon should be familiar with surgical techniques or surgical guides for any product or instruments that will be used.
- Additional products of varying types and sizes should be accessible in case of an unexpected need.
- This allograft and all packaging materials used by RTI are latex free.
- Sterile barrier packaging is protected by a dust barrier (e.g. box, sealed plastic pouch).
Adverse Reactions
Surgeons should discuss the following potential complications of tissue transplantation with their patients:
- Loss of function and/or integrity of transplanted tissue due to resorption, fragmentation, and/or disintegration including, but not limited to, associated loss of continuity, displacement, bending and/or fracture.
- Transmission of known infectious agents including, but not limited to, HIV, Hepatitis B, Hepatitis C, syphilis and bacteria.
- Immune rejection of transplanted grafts or allergic reactions to residual chemicals. This product may contain trace amounts of the following processing chemicals: ascorbic acid, detergent, hydrochloric acid, hydrogen peroxide, isopropyl alcohol, phosphate buffered saline, povidone-iodine.
- The same medical/surgical conditions that may complicate any surgical procedure may occur during or following the transplantation of an allograft.