510(k) · Cleared
ClearedAvon Patello-Femoral Joint Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Apr 6, 2001 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Apr 6, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- KRR
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK010100 Avon Patello-Femoral Joint ProsthesisHowmedica Osteonics Corp. · 2001
- Descendant · cites it directly · 11 of its ownK051086 Smith & Nephew Patello-Femoral ImplantSmith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 8 of its ownK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- Descendant · 3 generations on · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · cites it directly · 2 of its ownK082088 Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K051086Smith & Nephew Patello-Femoral ImplantSmith & Nephew, Inc. · 2005 · cites it directly11descendants
- K160738ZUK Select Knee SystemSmith & Nephew, Inc. · 2016 · 2 generations on8descendants
- K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 3 generations on7descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · 2 generations on3descendants
- K082088Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010100 | Avon Patello-Femoral Joint Prosthesis | Howmedica Osteonics Corp. | 2001 | — |
| +1 | K051086 | Smith & Nephew Patello-Femoral Implant | Smith & Nephew, Inc. | 2005 | — |
| +2 | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
| +3 | K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | 3 |
| +2 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +1 | K082088 | Mako Surgical Corp. Patellofemoral Knee Implant System II | Mako Surgical Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 153 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, K051086 (Smith & Nephew, Inc., 2005) has gone furthest, with 11 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 | — |
https://510kreport.com/device/K010100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010100: Avon Patello-Femoral Joint Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010100
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026