# K033883: Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Feb 13, 2004 after 60 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936079 (1994). 10 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933610: Exactech Cemented Total Knee System, Tibial Components, Exactech, Inc. (1995) Summary page 2.
- K011976: Optetrak Total Knee System Size 0/1 Delta (Line Extension), Exactech, Inc. (2001) Summary page 2.
- K032606: Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components, Exactech, Inc. (2003) Summary page 2.
- K010434: Optetrak B-Series Total Knee System, Exactech, Inc. (2001) Summary page 2.

## Most influential descendants
- K093360: Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T (2010), 15 descendants of its own
- K111400: Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component (2011), 12 descendants of its own
- K121307: Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak Logic CR Femoral Component, Siz (2012), 11 descendants of its own
- K123687: Optetrak Logic Porous Femoral Component (2013), 7 descendants of its own
- K153776: Optetrak One Logic Femoral Components (2016), 4 descendants of its own

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0584-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- Aug 30, 2021 · Class II · Z-0021-2022: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- Oct 9, 2014 · Class II · Z-0906-2015: Mislabeled

## Indications for use
The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system. OPTETRAK® HI-FLEx Tibial Inserts must be used with Optetrak® Hi-FLEX Femoral Components. CA UTION: In the USA, for cemented use only.

Source page: https://510kreport.com/device/K033883
Methodology: https://510kreport.com/methodology