510(k) Report

510(k) · Cleared

Cleared

Mako Surgical Corporation Unicondylar Knee Implant System Iii

K082081510(k) TraditionalCleared Oct 15, 200884-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 Oct 15, 2008 as substantially equivalent to K020741 (Encore Orthopedics, Inc., 2002) and 3 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1997. 12 later devices descend from it.

Decided
Oct 15, 2008
Review
84 days
Class
Class II
Product code
HSX
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K971938 (1997). 17 ancestors in all, the oldest K880155 (1988). 12 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2007: 1 other ancestor2006: 1 other ancestor2001: 3 other ancestors1999: 1 other ancestor1998: 1 other ancestor1988: 1 other ancestor2003: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor2013: 1 descendant cleared2017: 2 descendants cleared2019: 3 descendants cleared2021: 4 descendants cleared2026: 2 descendants clearedK971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled×2: 2 generations cleared close together, K020741 (2002), K022437 (2002) K080368 · Mako Surgical Corp. Unicondylar Knee Implant System II · Mako Surgical Corp. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 9 other ancestors3 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K080368 · Mako Surgical Corp. Unicondylar Knee Implant System II · Mako Surgical Corp. · 2008K022437 · 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 · 4 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
  2. 3 generations backK020741 Unicondylar KneeEncore Orthopedics, Inc. · 2002 · Recalled
  3. 2 generations backK022437 Uni KneeEncore Medical L.P. · 2002 · Recalled
  4. 1 generation backK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  5. This deviceK082081 Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp. · 2008
  6. Descendant · cites it directly · 11 of its ownK123380 Stride Unicondylar KneeBlue Belt Technologies, Inc. · 2013 · Recalled
  7. Descendant · 2 generations on · 8 of its ownK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
  8. Descendant · 3 generations on · 7 of its ownK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
  9. Descendant · 3 generations on · 4 of its ownK191150 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
  10. Descendant · 3 generations on · 3 of its ownK191996 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2019

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2013: 12017: 22019: 32021: 42026: 2
2013high 4 (2021) · low 0 (2014)2026

Most influential descendants

Showing 5 of 12 · See all
  • K123380Stride Unicondylar KneeBlue Belt Technologies, Inc. · 2013 · cites it directly11descendants
  • K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017 · 2 generations on8descendants
  • K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019 · 3 generations on7descendants
  • K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019 · 3 generations on4descendants
  • K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2019 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K971938Repicci II Unicondylar KneeBiomet, Inc.19971
−3K020741Unicondylar KneeEncore Orthopedics, Inc.20022
−2K022437Uni KneeEncore Medical L.P.20022
−1K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—
0 (this device)K082081Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp.2008—
+1K123380Stride Unicondylar KneeBlue Belt Technologies, Inc.20132
+2K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.2017—
+3K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.2019—
+3K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.2019—
+3K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.2019—

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
201310
201720
201930
202140
202620
FIG. 1 — Lineage of K082081, 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? (4)

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
*K020741Unicondylar Knee
Summary page 1
…Prosthesis Substantial Equivalence: The MAKO Surgical Corp. Unicondylar Knee Implant System III is substantially equivalent to the Encore EPIK®Uni Knee System (K020741 &K022437), MAKO Surgical Corp. Unicondylar Knee Implant System II (K080368), and the Zimmer Unicompartmental Knee System (ZUK -…
Encore Orthopedics, Inc.20022
*K022437Uni Knee
Summary page 1
…osthesis Substantial Equivalence: The MAKO Surgical Corp. Unicondylar Knee Implant System III is substantially equivalent to the Encore EPIK®Uni Knee System (K020741 &K022437), MAKO Surgical Corp. Unicondylar Knee Implant System II (K080368), and the Zimmer Unicompartmental Knee System (ZUK - K033363)…
Encore Medical L.P.20022
*K080368Mako Surgical Corp. Unicondylar Knee Implant System II
Summary page 1
…ylar Knee Implant System III is substantially equivalent to the Encore EPIK®Uni Knee System (K020741 &K022437), MAKO Surgical Corp. Unicondylar Knee Implant System II (K080368), and the Zimmer Unicompartmental Knee System (ZUK - K033363) Feature MAKO Surgical Corp. Unicondy…
Mako Surgical Corp.2008—
*K033363Zimmer Unicompartmental Knee System
Summary page 1
…the Encore EPIK®Uni Knee System (K020741 &K022437), MAKO Surgical Corp. Unicondylar Knee Implant System II (K080368), and the Zimmer Unicompartmental Knee System (ZUK - K033363) Feature MAKO Surgical Corp. Unicondylar Knee Implant System III (MUKSIII)…
Zimmer, Inc.20043

Also cleared against K020741: 3 other devices →

What descends from it? (12)

See all 12

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123380Stride Unicondylar KneeBlue Belt Technologies, Inc.201311

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 17 ancestors have a recall of any class.
  • Of its descendants, K123380 (Blue Belt Technologies, Inc., 2013) has gone furthest, with 11 descendants of its own.
  • 3 other devices also cite its predicate K020741.

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 III 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 K020741

3 other devices cite the same predicate.

  • K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
  • K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  • K022437Uni KneeEncore Medical L.P. · 20022 recalls

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/K082081 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082081: Mako Surgical Corporation Unicondylar Knee Implant System Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082081

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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