510(k) · Cleared

Recalled · Class II · 2023

Restoris Multicompartmental Knee (MCK) System

K090763510(k) TraditionalCleared Jun 17, 200986-day reviewClass II21 CFR 888.3560Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mako Surgical Corporation · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jun 17, 2009 as substantially equivalent to K082172 (Mako Surgical Corporation, 2008) after an 86-day review. Its family tree reaches back 6 generations to 1994. 50 later devices descend from it. It has been recalled 5 times.

Decided: Jun 17, 2009
Review: 86 days
Class: Class II
Product code: NPJ
Recalls: 5
Predicates: 1

Its longest line of descent runs back 6 generations to K943462 (1994). 31 ancestors in all, the oldest K880155 (1988). 50 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 6 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
5 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
4 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
3 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
2 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
1 generation backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
This deviceK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009
Descendant · cites it directly · 26 of its ownK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
Descendant · 2 generations on · 25 of its ownK150307 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 · cites it directly · 19 of its ownK133811 Restoris Porous Partial Knee SystemMako Surgical Corp. · 2014
Descendant · 2 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2013high 7 (2019) · low 1 (2013)2026

Most influential descendants

Showing 5 of 50 · See all

K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013 · cites it directly26descendants
K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015 · 2 generations on25descendants
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · cites it directly24descendants
K133811Restoris Porous Partial Knee SystemMako Surgical Corp. · 2014 · cites it directly19descendants
K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 2 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K943462	Darwin Knee System	Johnson & Johnson Professionals, Inc.	1994	8
−5	K033272	Depuy Sigma Tibial Inserts	DePuy Orthopaedics, Inc.	2004	51
−4	K040166	Depuy Sigma XLK Tibial Inserts	DePuy Orthopaedics, Inc.	2004	—
−3	K061648	Depuy Graduated Compartmental Knee (GCK)	DePuy Orthopaedics, Inc.	2006	1
−2	K070849	Depuy GCK Femoral and Tibial Components	DePuy Orthopaedics, Inc.	2007	—
−1	K082172	Mako Modular Knee Compartmental Implant System	Mako Surgical Corporation	2008	2
0 (this device)	K090763	Restoris Multicompartmental Knee (MCK) System	Mako Surgical Corporation	2009	—
+1	K133039	Restoris Multicompartmental Knee System	Mako Surgical Corporation	2013	—
+2	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
+1	K133811	Restoris Porous Partial Knee System	Mako Surgical Corp.	2014	—
+2	K173849	Triathlon Total Knee System	Stryker Orthopaedics	2018	3

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
2013	1	0
2014	1	0
2015	2	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

FIG. 1 — Lineage of K090763, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K082172	Mako Modular Knee Compartmental Implant System Summary page 2 …ility recognized ASTM standards. Substantial Equivalence: Restoris MCK is substantially equivalent to the MAKO Modular Knee Compartmental Knee System (K082172). Indications for Use: RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjuncti…	Mako Surgical Corporation	2008	2

Also cleared against K082172: 1 other device →

What descends from it? (50)

See all 50

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133039	Restoris Multicompartmental Knee System	Mako Surgical Corporation	2013	26
K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System	Stryker Orthopaedics	2017	24
K133811	Restoris Porous Partial Knee System	Mako Surgical Corp.	2014	19
K160461	Arthrex iBalance BiCompartmental Arthroplasty System	Arthrex, Inc.	2016	3

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 10, 2023	Class II	Z-1386-2023	Process change control	Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Mar 10, 2023	Class II	Z-1385-2023	Process change control	Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Jan 19, 2018	Class II	Z-2051-2018	Under Investigation by firm	Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Jan 15, 2016	Class II	Z-1031-2016	Unknown/Undetermined by firm	Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
Jan 9, 2014	Class II	Z-1132-2014	Error in labeling	The product may be mislabeled and could result in the incorrect implant being used.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
16 of the 31 ancestors have a recall of any class.
Of its descendants, K133039 (Mako Surgical Corporation, 2013) has gone furthest, with 26 descendants of its own.
1 other device also cites its predicate K082172.

How does its category compare?

All NPJ devices

NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NPJ

1in 2015

2007high 3 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NPJ

76in 2009

2007high 76 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NPJ

1in 2016

2007high 3 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NPJ

47in 2025

2007high 150 (2017) · low 0 (2007)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 MCK 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 MCK 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/K090763 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090763: Restoris Multicompartmental Knee (MCK) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090763

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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