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Arthrex BioSync® Bone Wedge

by Arthex, Inc.

510(k) K151256

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK151256 Date12 Aug 2015ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1963-2016 FDA Class II initiated 22 Apr 2016
    • Terminated Z-1960-2016 FDA Class II initiated 22 Apr 2016
    • Terminated Z-1962-2016 FDA Class II initiated 22 Apr 2016
    • Terminated Z-1958-2016 FDA Class II initiated 22 Apr 2016
    • Terminated Z-1961-2016 FDA Class II initiated 22 Apr 2016
    • Terminated Z-1959-2016 FDA Class II initiated 22 Apr 2016

    Potential for polystyrene particulate presence.

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  • Withdrawn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
PLF
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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