510(k) · Cleared

Cleared

Eius Unicompartmental Knee System

K033769510(k) SpecialCleared Feb 13, 200472-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

Howmedica Osteonics Corp. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cleared on Feb 13, 2004 as substantially equivalent to K992287 (Howmedica Osteonics Corp., 1999) and 3 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1993. 121 later devices descend from it.

Decided: Feb 13, 2004
Review: 72 days
Class: Class II
Product code: HSX
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K923011 (1993). 4 ancestors in all. 121 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK923011 Osteonics Unix UnicompartmentalOsteonics Corp. · 1993
This deviceK033769 Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004
Descendant · cites it directly · 62 of its ownK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
Descendant · cites it directly · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
Descendant · 2 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
Descendant · 3 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
Descendant · 2 generations on · 43 of its ownK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2005high 10 (2021) · low 1 (2010)2026

Most influential descendants

Showing 5 of 121 · 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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923011	Osteonics Unix Unicompartmental	Osteonics Corp.	1993	—
0 (this device)	K033769	Eius Unicompartmental Knee System	Howmedica Osteonics Corp.	2004	—
+1	K043570	Unicondylar Knee Repair System / Conformis Ucd	Conformis, Inc.	2005	3
+1	K080368	Mako Surgical Corp. Unicondylar Knee Implant System II	Mako Surgical Corp.	2008	—
+2	K082172	Mako Modular Knee Compartmental Implant System	Mako Surgical Corporation	2008	2
+3	K090763	Restoris Multicompartmental Knee (MCK) System	Mako Surgical Corporation	2009	5
+2	K052687	Conformis, Inc. Total Knee Repair System	Conformis, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0
1999	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K033769, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K992287	First Step Unicompartmental Knee System Summary page 1 …ci Unicompartmental All Polyethylene Tibia component (also available without a keel). The EIUS Unicompartmental Knee System was determined substantially equivalent under K992287, the UNIX Unicompartmental Knee was determined substantially equivalent under K92301 1, the Biomet component was cleared under K9…	Howmedica Osteonics Corp.	1999	—
*	K962152	Osteonics Scorpio Posteriorly Stabilized Total Knee System Summary page 1 …valent under K92301 1, the Biomet component was cleared under K980665, and the Scorpio Total Knee Tibial Insert components were determined substantially equivalent under K962152. Description of Device Modification This submission is intended to address a line extension to the EIUS ® Unicompartmental Knee…	Osteonics Corp.	1996	13
*	K923011	Osteonics Unix Unicompartmental Summary page 1 …The EIUS Unicompartmental Knee System was determined substantially equivalent under K992287, the UNIX Unicompartmental Knee was determined substantially equivalent under K92301 1, the Biomet component was cleared under K980665, and the Scorpio Total Knee Tibial Insert components were determined substantiall…	Osteonics Corp.	1993	—
*	K980665	Repicci II Unicondylar Knee All Poly Tibial Components Summary page 1 …ned substantially equivalent under K992287, the UNIX Unicompartmental Knee was determined substantially equivalent under K92301 1, the Biomet component was cleared under K980665, and the Scorpio Total Knee Tibial Insert components were determined substantially equivalent under K962152. Description of Devi…	Biomet, Inc.	1998	1

Also cleared against K992287: 3 other devices →

What descends from it? (121)

See all 121

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

Number	Device	Applicant	Decided	Descendants
K043570	Unicondylar Knee Repair System / Conformis Ucd	Conformis, Inc.	2005	62
K080368	Mako Surgical Corp. Unicondylar Knee Implant System II	Mako Surgical Corp.	2008	56
K071881	Triathlon PKR System	Howmedica Osteonics Corp.	2007	25
K060670	Accin Uni-Knee System	Accin Corporation	2006	6
K061779	Competitor Unicondylar All-Poly Tibial Baseplate	Smith & Nephew, Inc.	2006	5
K050373	Unicap Unicompartmental Knee Resurfacing Prosthesis	Arthrosurface, Inc.	2005	2
K072704	Unicompartmental Knee	Valpo Orthopedic Technology, Inc.	2008	0

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?

2 of the 4 ancestors have a recall of any class.
Of its descendants, K043570 (Conformis, Inc., 2005) has gone furthest, with 62 descendants of its own.
3 other devices also cite its predicate K992287.

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	—

What is it indicated for?

The EIUS ® Knee System 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 or other procedure

* 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.

https://510kreport.com/device/K033769 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033769: Eius 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/K033769

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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