Skip to content

OsteoSelect Demineralized Bone Matrix Putty

by Bacterin International, Inc. 2 variants

510(k) K091321

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091321 Date11 Sep 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1138-2013 FDA Class II initiated 21 Feb 2013 on shared 510(k) K091321

    The firm's retesting procedure was not validated.

    • Terminated Z-0800-2013 FDA Class II initiated 18 Apr 2012 on shared 510(k) K091321

    Expired product was shipped to two customers.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQV
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OsteoSelect Demineralized Bone Matrix Putty is a demineralized bone matrix device classified as a bone graft substitute. It is designed to provide a scaffold for bone regeneration by delivering growth factors and structural support to promote healing in bony defects, including those in extremities and the pelvis. The putty formulation facilitates easy application and conformability to irregular surgical sites, enhancing integration with native tissue. Its composition is derived from demineralized bone, retaining osteoinductive properties while eliminating mineralized components that could interfere with biological activity.

This putty is supplied as a sterile, single-use medical device intended for surgical use in orthopedic procedures. It is packaged in a sterile, ready-to-use form, requiring no intra-operative mixing, and is compatible with standard surgical environments. The device is regulated under FDA 510(k) clearance (K091321) as a substantially equivalent predicate device, adhering to orthopedic standards. Storage instructions specify protection from moisture and extreme temperatures, and it is intended for one-time use per package. No MRI safety classifications or reusable applications are indicated in the specifications.

Other devices from Bacterin International, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the OsteoSelect Demineralized Bone Matrix Putty used for?

    The OsteoSelect Demineralized Bone Matrix Putty is designed as a bone graft substitute to support bone regeneration. It provides a scaffold that delivers growth factors and structural support, promoting healing in bony defects such as those found in extremities or the pelvis. The putty’s demineralized bone composition retains osteoinductive properties, encouraging new bone formation while avoiding mineral interference.

  • How is the OsteoSelect Demineralized Bone Matrix Putty supplied and prepared for use?

    The putty is supplied in a sterile, ready-to-use form, eliminating the need for intra-operative mixing. Each package is intended for single-use only, ensuring sterility and consistency. It is packaged for direct application in surgical environments, making it convenient for orthopedic procedures.

  • Is the OsteoSelect Demineralized Bone Matrix Putty reusable or single-use?

    The device is explicitly intended for single-use per package. This ensures sterility and maintains the integrity of its osteoinductive properties, as reuse could compromise its performance and safety.

  • What storage conditions are required for the OsteoSelect Demineralized Bone Matrix Putty?

    The putty must be stored protected from moisture and extreme temperatures to preserve its sterility and effectiveness. Adhering to these conditions ensures the device remains ready for surgical use without degradation.

  • Does the OsteoSelect Demineralized Bone Matrix Putty have any special handling instructions?

    Beyond standard sterile surgical handling, the putty requires no additional preparation due to its ready-to-use formulation. Its conformable putty texture allows for easy application to irregular surgical sites, ensuring proper integration with native tissue.