510(k) · Cleared
ClearedOvertureTi Knee Resurfacing SystemTM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Overture Orthopaedics · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Oct 7, 2024 as substantially equivalent to K221292 (Overture Resurfacing, Inc., 2023) after a 26-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Oct 7, 2024
- Review
- 26 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923011 (1993). 10 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK923011 Osteonics Unix UnicompartmentalOsteonics Corp. · 1993
- 3 generations backK033769 Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004
- 2 generations backK050373 Unicap Unicompartmental Knee Resurfacing ProsthesisArthrosurface, Inc. · 2005
- 1 generation backK221292 Uni Knee Resurfacing SystemOverture Resurfacing, Inc. · 2023
- This deviceK242746 OvertureTi Knee Resurfacing SystemTMOverture Orthopaedics · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923011 | Osteonics Unix Unicompartmental | Osteonics Corp. | 1993 | — |
| −3 | K033769 | Eius Unicompartmental Knee System | Howmedica Osteonics Corp. | 2004 | — |
| −2 | K050373 | Unicap Unicompartmental Knee Resurfacing Prosthesis | Arthrosurface, Inc. | 2005 | — |
| −1 | K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K221292 | Uni Knee Resurfacing SystemSummary page 6…Overture Orthopaedics Special 510(k) Submission Primary Predicate Device: Uni Knee Resurfacing System (K221292) There are no additional predicate devices or reference devices cited in this submission. DEVICE DESCRIPTION: The OvertureT… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 10.2 years on median.
- 5 of the 10 ancestors have a recall of any class.
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. 2024, 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 OvertureTi 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 as stated in the FDA summary.
https://510kreport.com/device/K242746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242746: OvertureTi Knee Resurfacing SystemTM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242746
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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