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 Corp. · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 10, 2015 as substantially equivalent to K133039 (Mako Surgical Corporation, 2013) after a 29-day review. Its family tree reaches back 8 generations to 1994. 25 later devices descend from it.
- Decided
- Mar 10, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- NPJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K943462 (1994). 33 ancestors in all, the oldest K880155 (1988). 25 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 7 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 6 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 5 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 4 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 3 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 2 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 1 generation backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- This deviceK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- Descendant · cites it directly · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- Descendant · 2 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- Descendant · 2 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
- Descendant · 2 generations on · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 2 generations on · 4 of its ownK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · cites it directly24descendants
- K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 2 generations on14descendants
- K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 2 generations on11descendants
- K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
- K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −7 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −6 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −5 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −4 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −3 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −2 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −1 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| 0 (this device) | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
| +1 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| +2 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| +2 | K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019 | — |
| +2 | K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +2 | K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | 1 |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133039 | Restoris Multicompartmental Knee SystemSummary page 5…Device Name Manufacturer 510(k) # RESTORIS Multicompartmental Knee System MAKO K133039 Section_004_Page2… | 2013 |
What descends from it? (25)
See all 252 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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 17 of the 33 ancestors have a recall of any class.
- Of its descendants, K172326 (Stryker Orthopaedics, 2017) has gone furthest, with 24 descendants of its own.
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. 2015, 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
posttraumatic 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/K150307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150307: 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/K150307
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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