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2.4mm Sternalock (Tm) System 71-2716

by Biomet Microfixation, Inc

2.4mm Sternalock (Tm) System 71-2716 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K161896 on 2 Aug 2016 (2 earlier submissions) and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036071769), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK161896 Date2 Aug 2016DecidedStatusActive
United StatesGUDID listing Number00841036071769 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161896 decided 2 Aug 2016 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00841036071769 listed 11 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0843-2012 FDA Unclassified (pre-2012) initiated 23 Nov 2011

    Biomet Microfixation, Inc., Jacksonville, FL recalled their SternaLock Blu Implant Tray on 11/23/11, model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the Screw Measuring Area. If used incorrectly, the screw measuring area inside the SternaLock Blu Implant Tray, could lead to the improper selection of a screw 2mm longer than needed.

Timeline

5 dated events

  1. Cleared FDA 510(k) K110574
  2. Recall initiated FDA recalls Z-0843-2012
  3. Cleared FDA 510(k) K121302
  4. Listed FDA GUDID 00841036071769
  5. Cleared FDA 510(k) K161896

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
2.4mm Sternalock (Tm) System
Generic name
Sternal fixation device
Model / Ref / Catalog
71-2716
Primary DI / UDI-DI
00841036071769
510(k) Number
FDA product code
HRS
GMDN term
Sternal fixation device
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Sternal fixation device

Cleared under the same submission (K110574)

and 8 more cleared under K110574

Cleared under the same submission (K121302)

and 8 more cleared under K121302

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)