# K071738: Exactech Optetrak Proximal Tibial Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Aug 15, 2007 after 50 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K936079 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932776: Cruciate Retaining Cemented Tibial Components, Exactech, Inc. (1994) Summary page 1.
- K933610: Exactech Cemented Total Knee System, Tibial Components, Exactech, Inc. (1995) Summary page 1.
- K936079: Ecactech Porous Coated Finned Tibial Tray Compnent, Exactech, Inc. (1994) Summary page 1.
- K954208: Optetrak Constrained Condylar Knee for Cemented Use Only, Exactech, Inc. (1996) Summary page 1.
- K011976: Optetrak Total Knee System Size 0/1 Delta (Line Extension), Exactech, Inc. (2001) Summary page 1.
- K023186: Optetrak Total Knee System Offset Tibial Tray, Exactech, Inc. (2002) Summary page 1.
- K033883: Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi, Exactech, Inc. (2004) Summary page 1.

## Recalls of this device
- Feb 1, 2013 · Class II · Z-0953-2013: A dimensional mismatch was identified which can potentially allow for interference between devices.
- Oct 17, 2011 · Class II · Z-2234-2012: Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.

## Indications for use
The OPTETRAK Comprehensive 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 Comprehensive 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, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

Source page: https://510kreport.com/device/K071738
Methodology: https://510kreport.com/methodology