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Tsp Hip Fx Plating SYSTEM4.5MM Cortical Locking Screw 14-454042

by Biomet Orthopedics, Inc.

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

2 closed

Documents

510(k) K140018

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868075933 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140018 Date4 Apr 2014DecidedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1347-2020 FDA Class II initiated 7 Jan 2020

    Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.

    • Terminated Z-2240-2016 FDA Class II initiated 10 Jun 2016

    The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tsp Hip Fx Plating SYSTEM4.5MM Cortical Locking Screw
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Model / Ref / Catalog
14-454042
Primary DI / UDI-DI
00887868075933
510(k) Number
FDA product code
KTT, JDO
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K140018)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (10)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No