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Optetrak 208-04-11

by Exactech, 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

34 closed

Documents

510(k) K023186

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 Number10885862053275 UDI-DI Date30 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK023186 Date17 Oct 2002DecidedStatusActive

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

GUDID

Trade name
Optetrak
Generic name
Uncoated knee tibia prosthesis, metallic
Model / Ref / Catalog
208-04-11
Primary DI / UDI-DI
10885862053275
510(k) Number
FDA product code
JWH
GMDN term
Uncoated knee tibia prosthesis, metallic
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated knee tibia prosthesis, metallic

Cleared under the same submission (K023186)

Show all (12)

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial 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
  • Lot / batch number: No
  • Manufacturing date: No