Puros®-S and Puros-S2 Cervical Interbody Allograft Implants

Puros-S

Our sterile Puros-S is an all-cortical allograft that 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 designed to simplify implantation and improve ease of use.

Puros-S2

The sterile Puros-S2 cervical implant, machined from cortical and cancellous bone and designed to maintain the height of the interbody space, provides an osteoconductive lattice for bony in-growth. 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 designed to simplify implantation and improve ease of use.

Puros-S

  • The strength of all-cortical bone
  • Center void for adding biologic material of choice
  • Tapered leading edge to facilitate easy insertion through distraction
  • Stringent quality standards that meet all FDA donor screening and testing requirements

Puros-S2

  • Strength of cortical bone with an osteoconductive cancellous center
  • Designed and tested to withstand compressive loads and impact forces, while minimizing breakage
  • Tapered leading edge to facilitate easy insertion through distraction
  • Stringent quality standards that meet all FDA donor screening and testing requirements

Product 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).

 

Special Instructions and 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.

Legal Manufacturer:

Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminster, CO 80021 USA


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This material is intended for health care professionals.  Distribution to any other recipient is prohibited.
For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website.