# K040889: Exactech Optetrak Unicondylar Knee

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Oct 1, 2004 after 179 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942263 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942263: Miller/Galante Precoat Unicompartmental Knee System, Zimmer, Inc. (1995) Summary page 3.
- K010810: Depuy Preservation Unicondylar Knee Prosthesis, DePuy Orthopaedics, Inc. (2001)

## Cited in the summary but kept off the family tree
- K944186: Sinuscope, Stryker Endoscopy (1994). Our reading of the summary gave K944186, FDA’s number for Sinuscope (Stryker Endoscopy). Its FDA name has none of the distinctive words the summary uses for the device it names, “Link Endo-Modell”. Kept off the family tree. Summary page 3.

## Recalls of this device
- Aug 30, 2021 · Class II · Z-0020-2022: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

## Indications for use
The Exactech Optetrak® Unicondylar Knee System is intended for partial replacement of the medial or lateral articulating surface of the knee joint. The system is indicated for primary surgery in skeletally mature patients with one or more of the following clinical conditions: Non-inflammatory osteoarthritis, osteonecrosis and/or traumatic arthritis Functional deformity Tibial condyle or plateau fractures that are not manageable by other techniques Traumatic bone and/or cartilage lesions All components are intended for cemented use only.

Source page: https://510kreport.com/device/K040889
Methodology: https://510kreport.com/methodology