510(k) · Cleared
ClearedMako Surgical Corp. Patellofemoral Knee Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mako Surgical Corp. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on May 16, 2008 as substantially equivalent to K020841 (Howmedica Osteonics Corp., 2002) and 1 other predicate after a 133-day review. Its family tree reaches back 1 generation to 2002. 55 later devices descend from it.
- Decided
- May 16, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- KRR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K020841 (2002). 2 ancestors in all. 55 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK020841 Avon Patellar ComponentHowmedica Osteonics Corp. · 2002
- This deviceK080029 Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp. · 2008
- Descendant · cites it directly · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- Descendant · 2 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- Descendant · 3 generations on · 26 of its ownK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- Descendant · 4 generations on · 25 of its ownK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- Descendant · 3 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · cites it directly51descendants
- K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 2 generations on50descendants
- K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013 · 3 generations on26descendants
- K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015 · 4 generations on25descendants
- K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020841 | Avon Patellar Component | Howmedica Osteonics Corp. | 2002 | — |
| 0 (this device) | K080029 | Mako Surgical Corp. Patellofemoral Knee Implant System | Mako Surgical Corp. | 2008 | — |
| +1 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| +2 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| +3 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| +4 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
| +3 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K010900 | FDA’s K010900 is STS-T Lithotripter, Model STS-T Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K020841 | Avon Patellar ComponentSummary page 1…n TMPatello-femoral Joint Prosthesis (510k # - K01~ 000); Avon TMPatellar Component (510k # K020841); Avon TM Extra Small Patello-femoral Replacement (510Ok # K041160) and Avon TMPFJ Prosthesis; (510Ok # KO0i1948). F… | 2002 |
| * | K041160 | Avon Extra-Small Patello-Femoral ReplacementSummary page 1…000); Avon TMPatellar Component (510k # K020841); Avon TM Extra Small Patello-femoral Replacement (510Ok # K041160) and Avon TMPFJ Prosthesis; (510Ok # KO0i1948). Feature MAKO Surgical Corp. Patellofemoral K… | 2004 |
| Kept off the family tree | K061948 | FDA’s K061948 is Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
What descends from it? (55)
See all 553 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?
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. 2008, 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 MAKO Surgical Corp. Patellofemoral Knee Implant System 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.
These components are single use only and are intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080029 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080029: Mako Surgical Corp. Patellofemoral Knee Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080029
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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