510(k) · Cleared

Recalled · Class II · 2017

Miller/Galante Precoat Unicompartmental Knee

K880155510(k) TraditionalCleared Aug 3, 1988203-day reviewClass II21 CFR 888.3520Recalls 1

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 Aug 3, 1988 after a 203-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 151 later devices descend from it. It has been recalled once.

Decided: Aug 3, 1988
Review: 203 days
Class: Class II
Product code: HSX
Recalls: 1
Predicates: 0

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

This deviceK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988
Descendant · cites it directly · 144 of its ownK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
Descendant · 2 generations on · 62 of its ownK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
Descendant · 2 generations on · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
Descendant · 3 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
Descendant · 4 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled

Showing 5 of 151 descendants. See all descendants

Descendants cleared per year

2004high 13 (2021) · low 1 (2004)2026

Most influential descendants

Showing 5 of 151 · 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

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K880155	Miller/Galante Precoat Unicompartmental Knee	Zimmer, Inc.	1988	—
+1	K033363	Zimmer Unicompartmental Knee System	Zimmer, Inc.	2004	3
+2	K043570	Unicondylar Knee Repair System / Conformis Ucd	Conformis, Inc.	2005	3
+2	K080368	Mako Surgical Corp. Unicondylar Knee Implant System II	Mako Surgical Corp.	2008	—
+3	K082172	Mako Modular Knee Compartmental Implant System	Mako Surgical Corporation	2008	2
+4	K090763	Restoris Multicompartmental Knee (MCK) System	Mako Surgical Corporation	2009	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2006	3	0
2007	5	0
2008	7	0
2009	3	0
2010	1	0
2011	3	0
2012	10	0
2013	8	0
2014	7	0
2015	3	0
2016	9	0
2017	7	0
2018	4	0
2019	12	0
2020	11	0
2021	13	0
2022	6	0
2023	10	0
2024	9	0
2025	9	0
2026	8	0

FIG. 1 — Lineage of K880155, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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? (151)

See all 151

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

Number	Device	Applicant	Decided	Descendants
K033363	Zimmer Unicompartmental Knee System	Zimmer, Inc.	2004	144
K161592	Persona Partial Knee System	Biomet, Inc.	2016	5
K050373	Unicap Unicompartmental Knee Resurfacing Prosthesis	Arthrosurface, Inc.	2005	2
K081293	Univation Unicondylar Knee System	Aesculap Implant Systems, Inc.	2008	1
K120262	HLS Uni Evolution & U-Kneetec	Tornier, Inc.	2012	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 29, 2017	Class II	Z-1055-2018	Packaging	The 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.

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

2007high 7 (2019) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSX

59in 2025

2007high 160 (2017) · low 33 (2007)2026

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

Recalls per year · HSX

2in 2020

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	33	0	6
2008	4	102	0	4
2009	2	—	49	21
2010	3	74	0	58
2011	1	—	0	114
2012	5	88	0	83
2013	2	—	1	79
2014	0	—	0	66
2015	1	—	0	57
2016	3	147	1	107
2017	5	160	4	113
2018	2	—	0	159
2019	7	90	0	177
2020	4	40	2	273
2021	7	81	0	240
2022	2	—	0	257
2023	1	—	0	231
2024	4	133	0	172
2025	4	59	0	175
2026	2	—	0	—

https://510kreport.com/device/K880155 · printed Nov 6, 2026

Cite this page

510(k) Report. “K880155: Miller/Galante Precoat Unicompartmental Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880155

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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