510(k) · Cleared
Recalled · Class II · 2021Exactech Optetrak Unicondylar Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Oct 1, 2004 as substantially equivalent to K942263 (Zimmer, Inc., 1995) and 1 other predicate after a 179-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- Oct 1, 2004
- Review
- 179 days
- Class
- Class II
- Product code
- HRY
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K942263 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK942263 Miller/Galante Precoat Unicompartmental Knee SystemZimmer, Inc. · 1995 · Recalled
- This deviceK040889 Exactech Optetrak Unicondylar KneeExactech, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942263 | Miller/Galante Precoat Unicompartmental Knee System | Zimmer, Inc. | 1995 | 1 |
| 0 (this device) | K040889 | Exactech Optetrak Unicondylar Knee | Exactech, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRY device
- #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K942263 | Miller/Galante Precoat Unicompartmental Knee SystemSummary page 3…K040889 - Page 3 of 4 Exactech Optetrak* Unicondylar Knee Technological Characteristics and Substantial Equivalence: Like the Zimmer MG (K942263) and Link Endo-Modell (K944186) femoral components, the Exactech Optetrak Unicondylar femoral com… | 1995 |
| Kept off the family tree | K944186 | FDA’s K944186 is Sinuscope 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…trak* Unicondylar Knee Technological Characteristics and Substantial Equivalence: Like the Zimmer MG (K942263) and Link Endo-Modell (K944186) femoral components, the Exactech Optetrak Unicondylar femoral component is built from cobalt- ch… | 1994 |
| * | K010810 | Depuy Preservation Unicondylar Knee Prosthesis | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2021 | Class II | Z-0020-2022 | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- 3 other devices also cite its predicate K942263.
How does its category compare?
All HRY devicesHRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRY
138in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRY
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRY
290in 2025
MAUDE reports naming product code HRY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 92 | 1 | 263 |
| 2008 | 3 | 138 | 1 | 285 |
| 2009 | 0 | — | 0 | 249 |
| 2010 | 1 | — | 0 | 180 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 1 | — | 0 | 137 |
| 2013 | 1 | — | 1 | 383 |
| 2014 | 1 | — | 0 | 305 |
| 2015 | 1 | — | 0 | 345 |
| 2016 | 1 | — | 1 | 343 |
| 2017 | 0 | — | 0 | 402 |
| 2018 | 0 | — | 0 | 613 |
| 2019 | 1 | — | 0 | 367 |
| 2020 | 1 | — | 1 | 1,054 |
| 2021 | 0 | — | 1 | 1,218 |
| 2022 | 0 | — | 3 | 840 |
| 2023 | 0 | — | 0 | 396 |
| 2024 | 0 | — | 0 | 430 |
| 2025 | 0 | — | 0 | 290 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040889: Exactech Optetrak Unicondylar Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040889
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026