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2.4mm System 91-2416

by Biomet Microfixation, Inc

2.4mm System 91-2416 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K113512 on 29 Jun 2012 (1 earlier submission) and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036053567), 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 StatesGUDID listing Number00841036053567 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK113512 Date29 Jun 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113512 decided 29 Jun 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841036053567 listed 11 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0282-2009 FDA Unclassified (pre-2012) initiated 11 Jul 2008

    The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW.

Timeline

4 dated events

  1. Cleared FDA 510(k) K001238
  2. Recall initiated FDA recalls Z-0282-2009
  3. Cleared FDA 510(k) K113512
  4. Listed FDA GUDID 00841036053567

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  • Withdrawn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" System
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog
91-2416
Primary DI / UDI-DI
00841036053567
510(k) Number
FDA product code
JEY, HWC
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
872.4760, 888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K001238)

and 8 more cleared under K001238

Cleared under the same submission (K113512)

and 8 more cleared under K113512

Similar devices in this category

Other devices filed under Orthopaedic bone screw, non-bioabsorbable, non-sterile.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)