Skip to content

207-80-02

by Exactech, Inc.

207-80-02 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K140302 on 30 Jul 2014 (4 earlier submissions) and listed in FDA GUDID since 18 Aug 2022 (UDI-DI 10885862198402), active as of 23 Oct 2026. 5 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

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862198402 UDI-DI Date18 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140302 Date30 Jul 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140302 decided 30 Jul 2014 Active· +4 more in the status table
  • FDA GUDID UDI-DI 10885862198402 listed 18 Aug 2022 Listed

Recalls

5 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0584-2024 FDA Class II initiated 21 Nov 2023
    • Ongoing Z-0583-2024 FDA Class II initiated 21 Nov 2023

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

    • Ongoing Z-0021-2022 FDA Class II initiated 30 Aug 2021

    Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

    • Terminated Z-0906-2015 FDA Class II initiated 9 Oct 2014

    Mislabeled

    • Terminated Z-2310-2012 FDA Class II initiated 19 Aug 2011

    Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.

Timeline

11 dated events

  1. Cleared FDA 510(k) K093360
  2. Cleared FDA 510(k) K111400
  3. Recall initiated FDA recalls Z-2310-2012
  4. Cleared FDA 510(k) K123687
  5. Cleared FDA 510(k) K140302
  6. Recall initiated FDA recalls Z-0906-2015
  7. Recall initiated FDA recalls Z-0021-2022
  8. Listed FDA GUDID 10885862198402
  9. Recall initiated FDA recalls Z-0584-2024
  10. Recall initiated FDA recalls Z-0583-2024

1 earlier event are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Knee arthroplasty force sensor balance kit
Model / Ref / Catalog
207-80-02
Primary DI / UDI-DI
10885862198402
510(k) Number
FDA product code
JWH
GMDN term
Knee arthroplasty force sensor balance kit
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Knee arthroplasty force sensor balance kit

Cleared under the same submission (K033883)

and 8 more cleared under K033883

Cleared under the same submission (K093360)

and 8 more cleared under K093360

Similar devices

Other devices filed under FDA product code JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER).

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)