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Unicondylar Knee

by Encore Orthopedics, Inc.

510(k) K020741

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020741 Date4 Jun 2002ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0009-2008 FDA Unclassified (pre-2012) initiated 9 Aug 2007
    • Terminated Z-0010-2008 FDA Unclassified (pre-2012) initiated 9 Aug 2007 on shared 510(k) K020741

    Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HRY
Device Class
Class II
Regulation
21 CFR Part 888.3530
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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