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Origen Dbm with Bioactive Glass, Nanofuse Dbm

by Nanotherapeutics, Inc.

510(k) K110976

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

Overview

The ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM device is a revolutionary orthopedic solution that utilizes bioactive glass and nanofused materials to provide effective bone void fillings. This innovative technology offers improved osseointegration, reduced healing time, and enhanced patient outcomes.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK110976 Date3 May 2011ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0347-2012 FDA Unclassified (pre-2012) initiated 10 Mar 2011
    • Terminated Z-0346-2012 FDA Unclassified (pre-2012) initiated 10 Mar 2011

    On 03/10/2011 Nanotherapeutics Inc, Alachua, FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). The same product is also distributed as NanoFUSE DBM Catalog # NAN109-02 (2cc) NAN109-05 (5cc) and NAN109-10(10cc). The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011

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  • Withdrawn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

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