510(k) · Cleared
ClearedAvon Patellar Component
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 11, 2002 after a 27-day review. The FDA summary names its predicate without a number. 58 later devices descend from it.
- Decided
- Apr 11, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- KRR
- Recalls
- None
- Predicates
- 0
58 later devices descend from it, 4 citing it directly.
- This deviceK020841 Avon Patellar ComponentHowmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 55 of its ownK080029 Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp. · 2008
- Descendant · 2 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- Descendant · 3 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- Descendant · 4 generations on · 26 of its ownK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- Descendant · 5 generations on · 25 of its ownK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K080029Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp. · 2008 · cites it directly55descendants
- K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · 2 generations on51descendants
- K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 3 generations on50descendants
- K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013 · 4 generations on26descendants
- K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015 · 5 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020841 | Avon Patellar Component | Howmedica Osteonics Corp. | 2002 | — |
| +1 | K080029 | Mako Surgical Corp. Patellofemoral Knee Implant System | Mako Surgical Corp. | 2008 | — |
| +2 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| +3 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| +4 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| +5 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | — | Kinemax® Plus All Polyethylene Patellar Component Named without a submission number |
What descends from it? (58)
See all 584 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, K080029 (Mako Surgical Corp., 2008) has gone furthest, with 55 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 subject Avon' Patellar Component is intended to be used with the Avon' Patello-Femoral Joint Replacement in replacement of the patello-femoral joint. The subject Avon" patellar component is a modification of the Kinemax® All Polyethylene Patellar Component. The Avon™ Patellar Component has been modified to include the addition of a blend radius on the medial aspect of the patella. This blend is designed to reduce the contact stress of the patella on…
Read the full statement (170 words)
The subject Avon' Patellar Component is intended to be used with the Avon' Patello-Femoral Joint Replacement in replacement of the patello-femoral joint. The subject Avon" patellar component is a modification of the Kinemax® All Polyethylene Patellar Component. The Avon™ Patellar Component has been modified to include the addition of a blend radius on the medial aspect of the patella. This blend is designed to reduce the contact stress of the patella on the patello-femoral component. The rest of the design features of the Avon patellar component are identical to that of the previous released Kinemax® All Polyethylene Patellar Component.
The Avon " Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
The Avon™ Patellar Component and the Avon" Patello-femoral Joint Prosthesis are intended for use 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/K020841 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020841: Avon Patellar Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020841
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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