510(k) Report

510(k) · Cleared

Cleared

Mako Surgical Corp. Unicondylar Knee Implant System II

K080368510(k) TraditionalCleared Jun 20, 2008129-day reviewClass II21 CFR 888.3520

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

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

Cleared on Jun 20, 2008 as substantially equivalent to K033363 (Zimmer, Inc., 2004) and 7 other predicates after a 129-day review. Its family tree reaches back 3 generations to 1997. 56 later devices descend from it.

Decided
Jun 20, 2008
Review
129 days
Class
Class II
Product code
HSX
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K971938 (1997). 16 ancestors in all, the oldest K880155 (1988). 56 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 1 other ancestor2004: 2 other ancestors1999: 1 other ancestor2003: 1 other ancestor2001: 3 other ancestors1998: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestor2008: 2 descendants cleared2013: 2 descendants cleared2009: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 4 descendants cleared2024: 5 descendants cleared2015: 2 descendants cleared2019: 7 descendants cleared2020: 6 descendants cleared2021: 5 descendants cleared2026: 7 descendants cleared2025: 4 descendants cleared2023: 4 descendants cleared2018: 2 descendants cleared2022: 3 descendants clearedK971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled×2: 2 generations cleared close together, K020741 (2002), K022437 (2002) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 8 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 9 descendants4 generations forward: 25 descendants5 generations forward: 14 descendants6 generations forward: 3 descendants K022437 · Uni Knee · Encore Medical L.P. · 2002 · recalledK020741 · Unicondylar Knee · Encore Orthopedics, Inc. · 2002 · recalledK971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled0+5
  1. Root · 3 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
  2. 2 generations backK020741 Unicondylar KneeEncore Orthopedics, Inc. · 2002 · Recalled
  3. 1 generation backK022437 Uni KneeEncore Medical L.P. · 2002 · Recalled
  4. This deviceK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  5. Descendant · cites it directly · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
  6. Descendant · 2 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
  7. Descendant · 3 generations on · 26 of its ownK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
  8. Descendant · 4 generations on · 25 of its ownK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
  9. 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 56 descendants. See all descendants

Descendants cleared per year

2008: 22009: 12013: 22014: 12015: 22016: 12017: 42018: 22019: 72020: 62021: 52022: 32023: 42024: 52025: 42026: 7
2008high 7 (2019) · low 0 (2010)2026

Most influential descendants

Showing 5 of 56 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−3K971938Repicci II Unicondylar KneeBiomet, Inc.19971
−2K020741Unicondylar KneeEncore Orthopedics, Inc.20022
−1K022437Uni KneeEncore Medical L.P.20022
0 (this device)K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—
+1K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation20082
+2K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095
+3K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation2013—
+4K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.2015—
+3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199310
199610
199810
199910
200130
200310
200420
200610
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200910
201320
201410
201520
201610
201740
201820
201970
202060
202150
202230
202340
202450
202540
202670
FIG. 1 — Lineage of K080368, 1997–2026Source: 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? (8)

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
*K033363Zimmer Unicompartmental Knee System
Summary page 1
…Prosthesis Substantial Equivalence: The MAKO Surgical Corp. Unicondylar Knee Implant System II is substantialj equivalent to Zimmer Unicompartmental Knee System K033363; Stryker EIUS, K992287 & K033769; Encore EPIIK' Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938;…
Zimmer, Inc.20043
*K992287First Step Unicompartmental Knee System
Summary page 1
…tantial Equivalence: The MAKO Surgical Corp. Unicondylar Knee Implant System II is substantialj equivalent to Zimmer Unicompartmental Knee System K033363; Stryker EIUS, K992287 & K033769; Encore EPIIK' Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938; MAKO Surgical Corp. Uni…
Howmedica Osteonics Corp.1999—
*K033769Eius Unicompartmental Knee System
Summary page 1
…uivalence: The MAKO Surgical Corp. Unicondylar Knee Implant System II is substantialj equivalent to Zimmer Unicompartmental Knee System K033363; Stryker EIUS, K992287 & K033769; Encore EPIIK' Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938; MAKO Surgical Corp. Unicondylar…
Howmedica Osteonics Corp.2004—
*K020741Unicondylar Knee
Summary page 1
…ndylar Knee Implant System II is substantialj equivalent to Zimmer Unicompartmental Knee System K033363; Stryker EIUS, K992287 & K033769; Encore EPIIK' Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938; MAKO Surgical Corp. Unicondylar Knee Implant System K060017 & K073248.…
Encore Orthopedics, Inc.20022
*K022437Uni Knee
Summary page 1
…e Implant System II is substantialj equivalent to Zimmer Unicompartmental Knee System K033363; Stryker EIUS, K992287 & K033769; Encore EPIIK' Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938; MAKO Surgical Corp. Unicondylar Knee Implant System K060017 & K073248.…
Encore Medical L.P.20022
*K971938Repicci II Unicondylar Knee
Summary page 1
…t to Zimmer Unicompartmental Knee System K033363; Stryker EIUS, K992287 & K033769; Encore EPIIK' Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938; MAKO Surgical Corp. Unicondylar Knee Implant System K060017 & K073248. Feature MAKO Surg…
Biomet, Inc.19971
*K060017Mako Surgical Unicondylar Knee System
Summary page 1
…S, K992287 & K033769; Encore EPIIK' Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938; MAKO Surgical Corp. Unicondylar Knee Implant System K060017 & K073248. Feature MAKO Surgical Corp. Unicondylar Knee Implant System II…
Mako Surgical Corp.2006—
*K073248Modification to:Mako Surgical Unicondylar Knee System
Summary page 1
…& K033769; Encore EPIIK' Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938; MAKO Surgical Corp. Unicondylar Knee Implant System K060017 & K073248. Feature MAKO Surgical Corp. Unicondylar Knee Implant System II…
Mako Surgical Corp.2007—

Also cleared against K033363: 21 other devices →

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation200851
K082081Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp.200812

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 11 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
  • 9 of the 16 ancestors have a recall of any class.
  • Of its descendants, K082172 (Mako Surgical Corporation, 2008) has gone furthest, with 51 descendants of its own.
  • 21 other devices also cite its predicate K033363.

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?

MAKO Surgical Corp. Unicondylar Knee Implant System II components are for use in unicompartmental knee arthroplasty as a result of:

* Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis

* Revision of previous unsuccessful unicompartmental knee replacement

* As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis

These components are single use only and are intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K033363

21 other devices cite the same predicate.

  • K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
  • K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems…Smith & Nephew, Inc. · 20231 recall
  • K211471Balanced Knee System UniOrtho Development Corporation · 2021
  • K203341ACS LD Uni FB Knee SystemImplantcast GmbH · 2021
  • K191325EMPOWR Partial KneeEncore Medical L.P. · 20192 recalls
  • K183029MOTO Partial Knee SystemMedacta International S.A. · 2019

More from Mako Surgical Corp.

33 FDA decisions under this applicant name. See the company

  • K260222Mako Total Knee ApplicationMako Surgical Corp. · 2026
  • K250608Mako Total Knee Application (3.0); Hybrid Tip PointerMako Surgical Corp. · 2025
  • K243751Mako Total Hip Application 5.0Mako Surgical Corp. · 2025
  • K242373Mako Shoulder Application (1.0)Mako Surgical Corp. · 2024
  • K241011Mako Total Knee ApplicationMako Surgical Corp. · 20241 recall

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/K080368 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080368: Mako Surgical Corp. Unicondylar Knee Implant System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080368

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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