510(k) · Cleared
ClearedRestoris Multicompartmental Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mako Surgical Corporation · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 10, 2013 as substantially equivalent to K090763 (Mako Surgical Corporation, 2009) after a 75-day review. Its family tree reaches back 7 generations to 1994. 26 later devices descend from it.
- Decided
- Dec 10, 2013
- Review
- 75 days
- Class
- Class II
- Product code
- NPJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K943462 (1994). 32 ancestors in all, the oldest K880155 (1988). 26 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 6 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 5 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 4 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 3 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 2 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 1 generation backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- This deviceK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- Descendant · cites it directly · 25 of its ownK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- Descendant · 2 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- Descendant · 3 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- Descendant · 3 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
- Descendant · 3 generations on · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015 · cites it directly25descendants
- K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 2 generations on24descendants
- K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 3 generations on14descendants
- K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 3 generations on11descendants
- K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −6 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −5 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −4 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −3 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −2 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −1 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| 0 (this device) | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| +1 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
| +2 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| +3 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| +3 | K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019 | — |
| +3 | K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 NPJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K090763 | Restoris Multicompartmental Knee (MCK) SystemSummary page 3…Manufacturer 510(k) U RESTORIS Multieompartmental Knee System MAKO K090763 Technological Characteristics: The RESTORI STM Multicompartmental Knee System is similar to legally marketed devices listed pre… | 2009 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150307 | RESTORIS Multicompartmental Knee System | 2015 | 25 |
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 17 of the 32 ancestors have a recall of any class.
- Of its descendants, K150307 (Mako Surgical Corp., 2015) has gone furthest, with 25 descendants of its own.
- 3 other devices also cite its predicate K090763.
How does its category compare?
All NPJ devicesNPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NPJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NPJ
76in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPJ
47in 2025
MAUDE reports naming product code NPJ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 3 | 76 | 0 | 3 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 0 | — | 0 | 72 |
| 2013 | 1 | — | 0 | 98 |
| 2014 | 0 | — | 0 | 75 |
| 2015 | 1 | — | 3 | 55 |
| 2016 | 0 | — | 1 | 93 |
| 2017 | 0 | — | 0 | 150 |
| 2018 | 0 | — | 0 | 141 |
| 2019 | 0 | — | 0 | 91 |
| 2020 | 0 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 51 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 52 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 47 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
* Medial unicondylar
* Lateral unicondylar
- Patellofemoral
* Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133039: Restoris Multicompartmental Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133039
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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