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Agc Knee System 155128

by Biomet Orthopedics, Inc.

Agc Knee System 155128 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K921182 on 23 Jul 1993 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304245662), 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

3 closed

Documents

510(k) K921182

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 Number00880304245662 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK921182 Date23 Jul 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K921182 decided 23 Jul 1993 Active
  • FDA GUDID UDI-DI 00880304245662 listed 24 Oct 2015 Listed

Recalls

3 recalls · FDA

    • Terminated Z-2149-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

  • 2 recalls, same reason

    • Terminated Z-0077-2008 FDA Unclassified (pre-2012) initiated 24 Jul 2007
    • Terminated Z-0076-2008 FDA Unclassified (pre-2012) initiated 24 Jul 2007

    Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.

Timeline

5 dated events

  1. Cleared FDA 510(k) K921182
  2. Recall initiated FDA recalls Z-0077-2008
  3. Recall initiated FDA recalls Z-0076-2008
  4. Listed FDA GUDID 00880304245662
  5. Recall initiated FDA recalls Z-2149-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Agc Knee System
Generic name
Coated knee tibia prosthesis
Model / Ref / Catalog
155128
Primary DI / UDI-DI
00880304245662
510(k) Number
FDA product code
HRY, JWH
GMDN term
Coated knee tibia prosthesis
Device class
Class II
Regulation number
888.3530, 888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated knee tibia prosthesis

Cleared under the same submission (K921182)

and 8 more cleared under K921182

Similar devices in this category

Other devices filed under Coated knee tibia prosthesis.

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)