Skip to content

Optetrak Logic 02-012-61-8162

by Exactech, Inc.

Optetrak Logic 02-012-61-8162 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K150890 on 29 May 2015 and listed in FDA GUDID since 30 Oct 2015 (UDI-DI 10885862273789), active as of 23 Oct 2026. 4 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

510(k) K150890

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862273789 UDI-DI Date30 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150890 Date29 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150890 decided 29 May 2015 Active
  • FDA GUDID UDI-DI 10885862273789 listed 30 Oct 2015 Listed

Recalls

4 recalls · 3 ongoing · FDA

    • 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-1364-2020 FDA Class II initiated 27 Jan 2020

    These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.

    • Ongoing Z-3209-2018 FDA Class II initiated 8 May 2018

    Potentially have non-conforming internal threads.

    • Terminated Z-2704-2017 FDA Class II initiated 7 Apr 2017

    Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.

Timeline

6 dated events

  1. Cleared FDA 510(k) K150890
  2. Listed FDA GUDID 10885862273789
  3. Recall initiated FDA recalls Z-2704-2017
  4. Recall initiated FDA recalls Z-3209-2018
  5. Recall initiated FDA recalls Z-1364-2020
  6. Recall initiated FDA recalls Z-0583-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optetrak Logic
Generic name
Knee femur stem prosthesis
Model / Ref / Catalog
02-012-61-8162
Primary DI / UDI-DI
10885862273789
510(k) Number
FDA product code
JWH
GMDN term
Knee femur stem prosthesis
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 16 Millimeter
Length — 120 Millimeter

Related devices

Category: Knee femur stem prosthesis

Cleared under the same submission (K150890)

and 8 more cleared under K150890

Similar devices in this category

Other devices filed under Knee femur stem prosthesis.

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, all answered No)