510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Mako Modular Knee Compartmental Implant System

K082172510(k) TraditionalCleared Nov 28, 2008119-day reviewClass II21 CFR 888.3520Recalls 2

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

Mako Surgical Corporation · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cleared on Nov 28, 2008 as substantially equivalent to K080029 (Mako Surgical Corp., 2008) and 4 other predicates after a 119-day review. Its family tree reaches back 5 generations to 1994. 51 later devices descend from it. It has been recalled 2 times.

Decided
Nov 28, 2008
Review
119 days
Class
Class II
Product code
HSX
Recalls
2
Predicates
5

Its longest line of descent runs back 5 generations to K943462 (1994). 30 ancestors in all, the oldest K880155 (1988). 51 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2005: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor2004: 3 other ancestors2002: 3 other ancestors2001: 3 other ancestors1999: 1 other ancestor1997: 2 other ancestors1991: 1 other ancestor2003: 1 other ancestor1998: 1 other ancestor1996: 2 other ancestors1995: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestor2009: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 3 descendants cleared2013: 1 descendant cleared2024: 5 descendants cleared2015: 2 descendants cleared2019: 7 descendants cleared2020: 6 descendants cleared2021: 5 descendants cleared2025: 4 descendants cleared2023: 4 descendants cleared2018: 2 descendants cleared2026: 6 descendants cleared2022: 3 descendants clearedK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled×2: 2 generations cleared close together, K033272 (2004), K040166 (2004) K061648 · Depuy Graduated Compartmental Knee (GCK) · DePuy Orthopaedics, Inc. · 2006 · recalledK070849 · Depuy GCK Femoral and Tibial Components · DePuy Orthopaedics, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 12 other ancestors3 generations back: 10 other ancestors 1 generation forward: 2 descendants2 generations forward: 8 descendants3 generations forward: 24 descendants4 generations forward: 14 descendants5 generations forward: 3 descendants K070849 · Depuy GCK Femoral and Tibial Components · DePuy Orthopaedics, Inc. · 2007K061648 · Depuy Graduated Compartmental Knee (GCK) · DePuy Orthopaedics, Inc. · 2006 · recalledK040166 · Depuy Sigma XLK Tibial Inserts · DePuy Orthopaedics, Inc. · 2004K033272 · Depuy Sigma Tibial Inserts · DePuy Orthopaedics, Inc. · 2004 · recalledK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled−50+5
  1. Root · 5 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 4 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
  3. 3 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
  4. 2 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
  5. 1 generation backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
  6. This deviceK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008
  7. Descendant · cites it directly · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
  8. Descendant · 2 generations on · 26 of its ownK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
  9. Descendant · 3 generations on · 25 of its ownK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
  10. Descendant · 2 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
  11. Descendant · cites it directly · 19 of its ownK133811 Restoris Porous Partial Knee SystemMako Surgical Corp. · 2014

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2009: 12013: 12014: 12015: 22016: 12017: 32018: 22019: 72020: 62021: 52022: 32023: 42024: 52025: 42026: 6
2009high 7 (2019) · low 0 (2010)2026

Most influential descendants

Showing 5 of 51 · See all
  • K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · cites it directly50descendants
  • K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013 · 2 generations on26descendants
  • K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015 · 3 generations on25descendants
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 2 generations on24descendants
  • K133811Restoris Porous Partial Knee SystemMako Surgical Corp. · 2014 · cites it directly19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K943462Darwin Knee SystemJohnson & Johnson Professionals, Inc.19948
−4K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200451
−3K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004—
−2K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.20061
−1K070849Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc.2007—
0 (this device)K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation2008—
+1K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095
+2K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation2013—
+3K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.2015—
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171
+1K133811Restoris Porous Partial Knee SystemMako Surgical Corp.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199110
199310
199510
199620
199720
199810
199910
200130
200230
200310
200430
200510
200610
200710
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201310
201410
201520
201610
201730
201820
201970
202060
202150
202230
202340
202450
202540
202660
FIG. 1 — Lineage of K082172, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HSX? 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 HSX device

  1. #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K080029Mako Surgical Corp. Patellofemoral Knee Implant System
Summary page 2
…bstantial Equivalence: The MAKO Surgical Corp. Compartmental Knee Implant System is substantially equivalent to MAKO Surgical Corp.'s Patellofemoral Knee Implant System (K080029); MAKO Surgical Corp.'s Unicondylar Knee Implant System II (K080368); Stryker® Compartmental Knee System (K052917); Depuy Graduat…
Mako Surgical Corp.2008—
*K080368Mako Surgical Corp. Unicondylar Knee Implant System II
Summary page 2
…plant System is substantially equivalent to MAKO Surgical Corp.'s Patellofemoral Knee Implant System (K080029); MAKO Surgical Corp.'s Unicondylar Knee Implant System II (K080368); Stryker® Compartmental Knee System (K052917); Depuy Graduated Compartmental Knee (K061648) and DePuy GCK Femoral and Tibial Com…
Mako Surgical Corp.2008—
*K052917Stryker Compartmental Knee System
Summary page 2
…KO Surgical Corp.'s Patellofemoral Knee Implant System (K080029); MAKO Surgical Corp.'s Unicondylar Knee Implant System II (K080368); Stryker® Compartmental Knee System (K052917); Depuy Graduated Compartmental Knee (K061648) and DePuy GCK Femoral and Tibial Components (K070849) Indications for Use: The M…
Howmedica Osteonics Corp.20058
*K061648Depuy Graduated Compartmental Knee (GCK)
Summary page 2
…t System (K080029); MAKO Surgical Corp.'s Unicondylar Knee Implant System II (K080368); Stryker® Compartmental Knee System (K052917); Depuy Graduated Compartmental Knee (K061648) and DePuy GCK Femoral and Tibial Components (K070849) Indications for Use: The MAKO Modular Knee Compartmental Implant System…
DePuy Orthopaedics, Inc.20061
*K070849Depuy GCK Femoral and Tibial Components
Summary page 2
…Knee Implant System II (K080368); Stryker® Compartmental Knee System (K052917); Depuy Graduated Compartmental Knee (K061648) and DePuy GCK Femoral and Tibial Components (K070849) Indications for Use: The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee re…
DePuy Orthopaedics, Inc.2007—

Also cleared against K080029: 2 other devices →

What descends from it? (51)

See all 51

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

NumberDeviceApplicantDecidedDescendants
K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation200950
K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 10, 2023Class IIZ-1386-2023Process change controlCertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Mar 10, 2023Class IIZ-1385-2023Process change controlCcertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
  • 15 of the 30 ancestors have a recall of any class.
  • Of its descendants, K090763 (Mako Surgical Corporation, 2009) has gone furthest, with 50 descendants of its own.
  • 2 other devices also cite its predicate K080029.

How does its category compare?

All HSX devices

HSX Prosthesis, Knee, Femorotibial, Non-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 · HSX

4in 2025

2007: 62008: 42009: 22010: 32011: 12012: 52013: 22015: 12016: 32017: 52018: 22019: 72020: 42021: 72022: 22023: 12024: 42025: 42026 (partial year): 2
2007high 7 (2019) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSX

59in 2025

2007: 33 days median2008: 102 days median2010: 74 days median2012: 88 days median2016: 147 days median2017: 160 days median2019: 90 days median2020: 40 days median2021: 81 days median2024: 133 days median2025: 59 days median
2007high 160 (2017) · low 33 (2007)2026

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

Recalls per year · HSX

2in 2020

2009: 492013: 12016: 12017: 42020: 2
2007high 49 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSX

175in 2025

2007: 62008: 42009: 212010: 582011: 1142012: 832013: 792014: 662015: 572016: 1072017: 1132018: 1592019: 1772020: 2732021: 2402022: 2572023: 2312024: 1722025: 175
2007high 273 (2020) · low 4 (2008)2025

MAUDE reports naming product code HSX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200763306
2008410204
20092—4921
2010374058
20111—0114
2012588083
20132—179
20140—066
20151—057
201631471107
201751604113
20182—0159
20197900177
20204402273
20217810240
20222—0257
20231—0231
202441330172
20254590175
20262—0—

What is it indicated for?

The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral and/or patellofemoral articular surfaces.

The MAKO Modular Knee Compartmental Implant System is for single use only and is intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K080029

2 other devices cite the same predicate.

  • K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella…Biomet Manufacturing Corp · 20131 recall
  • K082088Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008

More from Mako Surgical Corporation

8 FDA decisions under this applicant name. See the company

  • K142530Partial Knee Application (PKA)Mako Surgical Corporation · 2015
  • K150410Restoris Porous Partial Knee SystemMako Surgical Corporation · 2015
  • K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 20143 recalls
  • K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
  • K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 201212 recalls

Recent decisions in HSX

The HSX category page

  • K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026
  • K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026
  • K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025
  • K251834Persona Partial KneeZimmer Biomet · 2025
  • K251618MOTO Partial Knee System ExtensionMedacta International S.A. · 2025

https://510kreport.com/device/K082172 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082172: Mako Modular Knee Compartmental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082172

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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