Skip to content

Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T

by Exactech, Inc.

510(k) K093360

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

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

Overview

This OPTETRAK LOGICAL TOTAL KNEE SYSTEM Trapezoidal Tibial Tray is a semi-constrained, cemented prosthesis designed for orthopedic applications. It features a unique trapezoidal tibial tray that provides excellent stability and mobility for patients with knee injuries or arthritis.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK093360 Date11 Jan 2010ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • 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-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.

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  • Withdrawn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

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →