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Tibial augment 2803-5121

by United Orthopedic Corp.

Tibial augment 2803-5121 is a Class II device made by United Orthopedic Corp., cleared under FDA 510(k) K082424 on 16 Dec 2008 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 04712771482621), 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

1 ongoing

This device is named in the recall

Documents

510(k) K082424

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 Number04712771482621 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK082424 Date16 Dec 2008IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082424 decided 16 Dec 2008 Active
  • FDA GUDID UDI-DI 04712771482621 listed 24 Oct 2015 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2883-2026 FDA Class II initiated 20 May 2026

    Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

    • Terminated Z-1129-2018 FDA Class II initiated 24 Nov 2017

    UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.

Timeline

4 dated events

  1. Cleared FDA 510(k) K082424
  2. Listed FDA GUDID 04712771482621
  3. Recall initiated FDA recalls Z-1129-2018
  4. Recall initiated FDA recalls Z-2883-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tibial augment
Generic name
Posterior-stabilized total knee prosthesis
Model / Ref / Catalog
2803-5121
Primary DI / UDI-DI
04712771482621
510(k) Number
FDA product code
JWH
GMDN term
Posterior-stabilized total knee prosthesis
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Posterior-stabilized total knee prosthesis

Cleared under the same submission (K082424)

and 8 more cleared under K082424

Similar devices

Other devices filed under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

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