510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Zimmer Unicompartmental Knee System

K033363510(k) TraditionalCleared Jan 16, 200487-day reviewClass II21 CFR 888.3520Recalls 3

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 Jan 16, 2004 as substantially equivalent to K880155 (Zimmer, Inc., 1988) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1988. 144 later devices descend from it. It has been recalled 3 times.

Decided
Jan 16, 2004
Review
87 days
Class
Class II
Product code
HSX
Recalls
3
Predicates
2

Its longest line of descent runs back 1 generation to K880155 (1988). 2 ancestors in all. 144 later devices descend from it, 22 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2008: 6 descendants cleared2021: 13 descendants cleared2007: 5 descendants cleared2019: 12 descendants cleared2012: 9 descendants cleared2017: 7 descendants cleared2024: 8 descendants cleared2023: 9 descendants cleared2006: 3 descendants cleared2013: 7 descendants cleared2005: 1 descendant cleared2016: 9 descendants cleared2009: 3 descendants cleared2011: 3 descendants cleared2020: 11 descendants cleared2014: 7 descendants cleared2025: 9 descendants cleared2022: 6 descendants cleared2026: 8 descendants cleared2010: 1 descendant cleared2018: 4 descendants cleared2015: 3 descendants clearedK880155 · Miller/Galante Precoat Unicompartmental Knee · Zimmer, Inc. · 1988 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 22 descendants2 generations forward: 32 descendants3 generations forward: 15 descendants4 generations forward: 17 descendants5 generations forward: 27 descendants6 generations forward: 13 descendants7 generations forward: 12 descendants8 generations forward: 4 descendants9 generations forward: 2 descendants K880155 · Miller/Galante Precoat Unicompartmental Knee · Zimmer, Inc. · 1988 · recalled0+5
  1. Root · 1 generation backK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988 · Recalled
  2. This deviceK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004
  3. Descendant · cites it directly · 62 of its ownK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
  4. Descendant · cites it directly · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  5. Descendant · 2 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
  6. Descendant · 3 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
  7. Descendant · 2 generations on · 43 of its ownK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006

Showing 5 of 144 descendants. See all descendants

Descendants cleared per year

2005: 12006: 32007: 52008: 62009: 32010: 12011: 32012: 92013: 72014: 72015: 32016: 92017: 72018: 42019: 122020: 112021: 132022: 62023: 92024: 82025: 92026: 8
2005high 13 (2021) · low 1 (2005)2026

Most influential descendants

Showing 5 of 144 · See all
  • K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · cites it directly62descendants
  • K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008 · cites it directly56descendants
  • K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · 2 generations on51descendants
  • K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 3 generations on50descendants
  • K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006 · 2 generations on43descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K880155Miller/Galante Precoat Unicompartmental KneeZimmer, Inc.19881
0 (this device)K033363Zimmer Unicompartmental Knee SystemZimmer, Inc.2004—
+1K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.20053
+1K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—
+2K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation20082
+3K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095
+2K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200630
200750
200860
200930
201010
201130
201290
201370
201470
201530
201690
201770
201840
2019120
2020110
2021130
202260
202390
202480
202590
202680
FIG. 1 — Lineage of K033363, 1988–2026Source: 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? (2)

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
*K880155Miller/Galante Precoat Unicompartmental Knee
Summary page 1
…partmental Knee System are the Miller/Galante Precoat Unicompartmental Knee System, K880155 (cleared 8/3/88) and the Miller/Galante Precoat Unicompartmental…
Zimmer, Inc.19881
*K010685Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular…
Summary page 1
…lante Precoat Unicompartmental Knee System (8 mm Articular Surface) Line Extension, K010685 (cleared 4/2/01). Device Description: The Zimmer Unicompartmental Knee System…
Zimmer, Inc.2001—

Also cleared against K880155: 4 other devices →

What descends from it? (144)

See all 144

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

NumberDeviceApplicantDecidedDescendants
K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.200562
K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.200856
K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227
K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200726
K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215
K082081Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp.200812
K123380Stride Unicondylar KneeBlue Belt Technologies, Inc.201311
K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178
K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168
K112301Zimmer Patient Specific Instruments PlannerMaterialise NV20127

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 29, 2017Class IIZ-1054-2018PackagingThe LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Jan 11, 2016Class IIZ-0836-2016Process controlLDPE bag containing the implant adheres to the highly polished implant surface.
Aug 30, 2013Class IIZ-0076-2014Package design/selectionThe low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K043570 (Conformis, Inc., 2005) has gone furthest, with 62 descendants of its own.
  • 4 other devices also cite its predicate K880155.

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—

What is it indicated for?

These devices are indicated for patients with:

- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.

- Previous tibial condyle or plateau fractures with loss of anatomy or function.

- Varus or valgus deformities.

- Revision of previous arthroplasty procedures.

These devices are indicated for cemented use only.

The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Indications for use as stated in the FDA summary.

Also cleared against K880155

4 other devices cite the same predicate.

  • K161592Persona Partial Knee SystemBiomet, Inc. · 20162 recalls
  • K120262HLS Uni Evolution & U-KneetecTornier, Inc. · 2012
  • K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc. · 20088 recalls
  • K050373Unicap Unicompartmental Knee Resurfacing ProsthesisArthrosurface, Inc. · 2005

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/K033363 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033363: Zimmer Unicompartmental Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033363

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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