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Pediatric Locking Nail System 24220

by Biomet Orthopedics, Inc.

Pediatric Locking Nail System 24220 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K982953 on 21 Oct 1998 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304504653), active as of 23 Oct 2026. 3 FDA recalls are 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

4 closed

Documents

510(k) K982953

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304504653 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982953 Date21 Oct 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982953 decided 21 Oct 1998 Active
  • FDA GUDID UDI-DI 00880304504653 listed 24 Oct 2015 Listed

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2288-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009
    • Terminated Z-2289-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009

    Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

    • Terminated Z-2116-2009 FDA Unclassified (pre-2012) initiated 27 Mar 2009

    Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.

    • Terminated Z-0918-05 FDA Unclassified (pre-2012) initiated 16 Mar 2005 on shared 510(k) K982953

    The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.

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

Timeline

6 dated events

  1. Cleared FDA 510(k) K982953
  2. Recall initiated FDA recalls Z-0918-05
  3. Recall initiated FDA recalls Z-2116-2009
  4. Recall initiated FDA recalls Z-2288-2009
  5. Recall initiated FDA recalls Z-2289-2009
  6. Listed FDA GUDID 00880304504653

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pediatric Locking Nail System
Generic name
Bone nail implantable cap
Model / Ref / Catalog
24220
Primary DI / UDI-DI
00880304504653
510(k) Number
FDA product code
HSB
GMDN term
Bone nail implantable cap
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone nail end-cap

Cleared under the same submission (K982953)

and 8 more cleared under K982953

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)