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Agc Knee System 155134

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

3 closed

Documents

510(k) K921182

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304245693 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

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.

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  • Withdrawn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
155134
Primary DI / UDI-DI
00880304245693
510(k) Number
FDA product code
JWH, HRY
GMDN term
Coated knee tibia prosthesis
Device class
Class II
Regulation number
888.3560, 888.3530
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated knee tibia prosthesis

Cleared under the same submission (K921182)

Show all (12)

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)

  • Sterilise before use: 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