510(k) · Cleared
ClearedUni Knee Resurfacing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Overture Resurfacing, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Mar 10, 2023 as substantially equivalent to K050373 (Arthrosurface, Inc., 2005) after a 310-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Mar 10, 2023
- Review
- 310 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923011 (1993). 9 ancestors in all, the oldest K880155 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK923011 Osteonics Unix UnicompartmentalOsteonics Corp. · 1993
- 2 generations backK033769 Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004
- 1 generation backK050373 Unicap Unicompartmental Knee Resurfacing ProsthesisArthrosurface, Inc. · 2005
- This deviceK221292 Uni Knee Resurfacing SystemOverture Resurfacing, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK242746 OvertureTi Knee Resurfacing SystemTMOverture Orthopaedics · 2024
Most influential descendants
Showing 1 of 1 · See all- K242746OvertureTi Knee Resurfacing SystemTMOverture Orthopaedics · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923011 | Osteonics Unix Unicompartmental | Osteonics Corp. | 1993 | — |
| −2 | K033769 | Eius Unicompartmental Knee System | Howmedica Osteonics Corp. | 2004 | — |
| −1 | K050373 | Unicap Unicompartmental Knee Resurfacing Prosthesis | Arthrosurface, Inc. | 2005 | — |
| 0 (this device) | K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | 2023 | — |
| +1 | K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050373 | Unicap Unicompartmental Knee Resurfacing ProsthesisSummary page 4…all facets including function, design, performance, material, and intended use. Primary Predicate Device: Unicompartmental Knee Resurfacing Prosthesis (UniCAP™) (K050373) There are no additional predicate devices or reference devices cited in this submission. DEVICE DESCRIPTION: The Uni Knee Resu… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242746 | OvertureTi Knee Resurfacing SystemTM | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 10.2 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K242746 (Overture Orthopaedics, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Overture Resurfacing Uni Knee Resurfacing System is intended to be used in the partial replacement of the articulating surfaces of the knee in instances where, due to compartmental degenerative disease, post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or previous arthroplasty, only the one side of the joint is affected. This device is intended to be used with bone cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221292 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221292: Uni Knee Resurfacing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221292
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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