510(k) Report

510(k) · Cleared

Cleared

Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular Surface)

K010685510(k) SpecialCleared Apr 2, 200125-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

Zimmer, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cleared on Apr 2, 2001 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 149 later devices descend from it.

Decided
Apr 2, 2001
Review
25 days
Class
Class II
Product code
HSX
Recalls
None
Predicates
0

149 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2008: 7 descendants cleared2004: 1 descendant cleared2016: 9 descendants cleared2012: 10 descendants cleared2021: 13 descendants cleared2007: 5 descendants cleared2019: 12 descendants cleared2017: 7 descendants cleared2024: 8 descendants cleared2023: 9 descendants cleared2006: 3 descendants cleared2013: 8 descendants cleared2005: 1 descendant cleared2025: 9 descendants cleared2022: 6 descendants cleared2020: 11 descendants cleared2009: 3 descendants cleared2011: 3 descendants cleared2014: 7 descendants cleared2026: 8 descendants cleared2010: 1 descendant cleared2018: 4 descendants cleared2015: 3 descendants cleared200020052010201520202025
  1. This deviceK010685 Modification to Miller/Galante Precoat Unicompartmental Knee System…Zimmer, Inc. · 2001
  2. Descendant · cites it directly · 144 of its ownK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
  3. Descendant · 2 generations on · 62 of its ownK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  5. Descendant · 3 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
  6. Descendant · 4 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled

Showing 5 of 149 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12006: 32007: 52008: 72009: 32010: 12011: 32012: 102013: 82014: 72015: 32016: 92017: 72018: 42019: 122020: 112021: 132022: 62023: 92024: 82025: 92026: 8
2003high 13 (2021) · low 1 (2003)2026

Most influential descendants

Showing 5 of 149 · See all
  • K033363Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · cites it directly144descendants
  • K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · 2 generations on62descendants
  • K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008 · 2 generations on56descendants
  • K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · 3 generations on51descendants
  • K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 4 generations on50descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010685Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM…Zimmer, Inc.2001—
+1K033363Zimmer Unicompartmental Knee SystemZimmer, Inc.20043
+2K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.20053
+2K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—
+3K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation20082
+4K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
200630
200750
200870
200930
201010
201130
2012100
201380
201470
201530
201690
201770
201840
2019120
2020110
2021130
202260
202390
202480
202590
202680
FIG. 1 — Lineage of K010685, 2001–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (149)

See all 149

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

NumberDeviceApplicantDecidedDescendants
K033363Zimmer Unicompartmental Knee SystemZimmer, Inc.2004144
K161592Persona Partial Knee SystemBiomet, Inc.20165
K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc.20081
K022211HLS Uni Evolution ProsthesisTornier20031
K072704Unicompartmental KneeValpo Orthopedic Technology, Inc.20080

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?

  • Of its descendants, K033363 (Zimmer, Inc., 2004) has gone furthest, with 144 descendants of its own.

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.

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—

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, Inc. · 2026

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/K010685 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010685: Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular Surface).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010685

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026