510(k) · Cleared
ClearedHemicap Patello-Femoral Resurfacing Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Mar 16, 2006 after a 57-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Mar 16, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- KRR
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK060127 Hemicap Patello-Femoral Resurfacing ProsthesisArthrosurface, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK071413 Hemicap Patello-Femoral Resurfacing SystemArthrosurface, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK123907 Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral…Biomet Manufacturing Corp · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK231253 Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK221048 Episealer Patellofemoral SystemEpisurf Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK181280 Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 2018 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071413Hemicap Patello-Femoral Resurfacing SystemArthrosurface, Inc. · 2007 · cites it directly3descendants
- K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…Biomet Manufacturing Corp · 2013 · cites it directly1descendant
- K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc. · 2023 · cites it directly0descendants
- K221048Episealer Patellofemoral SystemEpisurf Medical, Inc. · 2022 · cites it directly0descendants
- K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060127 | Hemicap Patello-Femoral Resurfacing Prosthesis | Arthrosurface, Inc. | 2006 | — |
| +1 | K071413 | Hemicap Patello-Femoral Resurfacing System | Arthrosurface, Inc. | 2007 | — |
| +1 | K123907 | Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components… | Biomet Manufacturing Corp | 2013 | 1 |
| +1 | K231253 | Overture Orthopaedics Patellofemoral System | Overture Resurfacing, Inc. | 2023 | — |
| +1 | K221048 | Episealer Patellofemoral System | Episurf Medical, Inc. | 2022 | — |
| +2 | K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | Arthrosurface, Inc. | 2018 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 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?
The FDA summary names no predicate by number.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K071413 (Arthrosurface, Inc., 2007) has gone furthest, with 3 descendants of its own.
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.
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 HemiCAPTM Patello-femoral Resurfacing Prosthesis 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 as stated in the FDA summary.
https://510kreport.com/device/K060127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060127: Hemicap Patello-Femoral Resurfacing Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060127
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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