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Optetrak Total Knee System Offset Tibial Tray

by Exactech, Inc.

510(k) K023186

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

34 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 · Special NumberK023186 Date17 Oct 2002ClearedStatusActive

Recalls

34 recalls · FDA

  • 34 recalls, same reason

    • Terminated Z-0150-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0151-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0143-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0129-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0145-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0157-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0147-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0144-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0158-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0135-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0137-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0154-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0140-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0126-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0136-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0149-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0142-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0153-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0155-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0141-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0146-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0156-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0159-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0139-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0128-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0127-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0152-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0130-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0132-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0131-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0138-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0134-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0148-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0133-2018 FDA Class II initiated 19 Sep 2017

    There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

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
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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