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Ptn Peritrochanteric Nail 29253

by Biomet Orthopedics, Inc.

Ptn Peritrochanteric Nail 29253 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K050118 on 16 Feb 2005 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304507647), active as of 23 Oct 2026. 2 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

3 closed

Documents

510(k) K050118

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 Number00880304507647 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050118 Date16 Feb 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050118 decided 16 Feb 2005 Active
  • FDA GUDID UDI-DI 00880304507647 listed 24 Oct 2015 Listed

Recalls

3 recalls · FDA

    • Terminated Z-1819-2016 FDA Class II initiated 1 Apr 2016

    Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

    • Terminated Z-1478-2012 FDA Not yet classified initiated 30 Mar 2012

    The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation

    • Terminated Z-0012-06 FDA Unclassified (pre-2012) initiated 24 Jun 2005 on shared 510(k) K050118

    Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K050118
  2. Recall initiated FDA recalls Z-0012-06
  3. Recall initiated FDA recalls Z-1478-2012
  4. Listed FDA GUDID 00880304507647
  5. Recall initiated FDA recalls Z-1819-2016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ptn Peritrochanteric Nail
Generic name
Bone nail implantable cap
Model / Ref / Catalog
29253
Primary DI / UDI-DI
00880304507647
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 (K050118)

and 8 more cleared under K050118

Similar devices in this category

Other devices filed under Bone nail end-cap.

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)