Exactech Optetrak Logic Enhanced Assembly

• • Ongoing Z-0585-2024 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-0023-2022 FDA Class II ·initiated 30 Aug 2021

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

• • Terminated Z-1208-2019 FDA Class II ·initiated 13 Mar 2019

  2.5 Truliant Fit Trays were mismarked as 3

510(k) Number

K152170 ↗

FDA product code

JWH

Device class

Class II

Regulation

21 CFR Part 888.3560

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

See all devices from Exactech, Inc. →

• What is the Exactech Optetrak Logic Enhanced Assembly used for?

  The Exactech Optetrak Logic Enhanced Assembly is an orthopedic knee implant system designed for total knee arthroplasty procedures. It includes femoral, tibial, and patellar components engineered to provide stability and range of motion, with options for cruciate-retaining and posterior-stabilized configurations to match patient anatomy and surgical needs.

• How is the Exactech Optetrak Logic Enhanced Assembly supplied and is it reusable?

  This device is supplied as a non-sterile, reusable implant system intended for use by trained medical professionals in a hospital or surgical center setting. It should be handled according to manufacturer guidelines to maintain integrity prior to implantation.

• What regulatory status does the Exactech Optetrak Logic Enhanced Assembly have?

  The Exactech Optetrak Logic Enhanced Assembly is governed by FDA 510(k) clearance K152170, which determined it to be substantially equivalent to a legally marketed predicate device. It is not MRI safe unless specifically tested and labeled as such.

• Are there different models or configurations available for the Exactech Optetrak Logic Enhanced Assembly?

  Yes, the Exactech Optetrak Logic Enhanced Assembly is available in cruciate-retaining (CR) and posterior-stabilized (PS) configurations to match patient anatomy and surgical needs. These options allow surgeons to select the most appropriate design for each patient's specific requirements.