510(k) · Cleared
ClearedOverture Orthopaedics Patellofemoral System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Overture Resurfacing, Inc. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jul 7, 2023 as substantially equivalent to K060127 (Arthrosurface, Inc., 2006) after a 67-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Jul 7, 2023
- Review
- 67 days
- Class
- Class II
- Product code
- KRR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060127 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK060127 Hemicap Patello-Femoral Resurfacing ProsthesisArthrosurface, Inc. · 2006
- This deviceK231253 Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060127 | Hemicap Patello-Femoral Resurfacing Prosthesis | Arthrosurface, Inc. | 2006 | — |
| 0 (this device) | K231253 | Overture Orthopaedics Patellofemoral System | Overture Resurfacing, Inc. | 2023 | — |
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 KRR? 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 KRR device
- #1 K221048 Episealer Patellofemoral Systemscore 4.6 · 1 generation · 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 |
|---|---|---|---|
| * | K060127 | Hemicap Patello-Femoral Resurfacing ProsthesisSummary page 4…ODUCT CODE: KRR Predicate Device: Arthrosurface, Inc. HemiCAPTM Patello-Femoral Resurfacing Prosthesis (K060127) Reference Device: Overture Resurfacing Inc. Uni Knee Resurfacing System (K221292) DEVICE DESCRIPTION: The Overtur… | 2006 |
| † | K221292 | Uni Knee Resurfacing System | 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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K060127.
How does its category compare?
All KRR devicesKRR Prosthesis, Knee, Patello/Femoral, Semi-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 · KRR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KRR
116in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRR
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRR
36in 2025
MAUDE reports naming product code KRR, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 116 | 0 | 0 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 1 | — | 1 | 9 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 1 | — | 1 | 14 |
| 2017 | 0 | — | 2 | 15 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 1 | — | 3 | 9 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Overture Orthopaedics Patellofemoral System is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
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/K231253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231253: Overture Orthopaedics Patellofemoral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231253
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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