510(k) · Cleared

Cleared

Arthrex Univers 30 Shoulder Prosthesis

K010124510(k) TraditionalCleared Apr 6, 200180-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrex, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Apr 6, 2001 after an 80-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 6, 2001
Review: 80 days
Class: Class II
Product code: KWS
Recalls: None
Predicates: 0

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

This deviceK010124 Arthrex Univers 30 Shoulder ProsthesisArthrex, Inc. · 2001
Descendant · cites it directly · 130 of its ownK032126 Promos ShoulderPlus Orthopedics · 2004
Descendant · cites it directly · 71 of its ownK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
Descendant · 2 generations on · 67 of its ownK063578 Promos Modular Shoulder SystemPlus Orthopedics AG · 2007 · Recalled
Descendant · 3 generations on · 52 of its ownK081016 Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. · 2008 · Recalled
Descendant · 4 generations on · 44 of its ownK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · Recalled

Showing 5 of 149 descendants. See all descendants

Descendants cleared per year

2004high 13 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 149 · See all

K032126Promos ShoulderPlus Orthopedics · 2004 · cites it directly130descendants
K042021Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · cites it directly71descendants
K063578Promos Modular Shoulder SystemPlus Orthopedics AG · 2007 · 2 generations on67descendants
K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. · 2008 · 3 generations on52descendants
K110598SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · 4 generations on44descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010124	Arthrex Univers 30 Shoulder Prosthesis	Arthrex, Inc.	2001	—
+1	K032126	Promos Shoulder	Plus Orthopedics	2004	—
+1	K042021	Exactech Equinoxe Shoulder System	Exactech, Inc.	2004	10
+2	K063578	Promos Modular Shoulder System	Plus Orthopedics AG	2007	4
+3	K081016	Smith & Nephew, Inc., Promos Reverse Shoulder System	Smith & Nephew, Inc.	2008	2
+4	K110598	SMR Reverse Shoulder System	Lima Corporate S.P.A.	2011	1

Descendants by year cleared

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

FIG. 1 — Lineage of K010124, 2001–2026Source: 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 KWS? 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 KWS device

#1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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? (149)

See all 149

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

Number	Device	Applicant	Decided	Descendants
K032126	Promos Shoulder	Plus Orthopedics	2004	130
K042021	Exactech Equinoxe Shoulder System	Exactech, Inc.	2004	71
K071032	Arthrex Univers II Shoulder Prosthesis	Arthrex, Inc.	2007	21
K083435	Arthrex Univers II Shoulder Pegged Glenoid	Arthrex, Inc.	2009	5
K120044	Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-Keeled	Arthrex, Inc.	2012	4

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, K032126 (Plus Orthopedics, 2004) has gone furthest, with 130 descendants of its own.

How does its category compare?

All KWS devices

KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWS

3in 2025

2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2007high 250 (2023) · low 33 (2010)2026

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

Recalls per year · KWS

2in 2023

2007high 29 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWS

2,281in 2025

2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, 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	2	—	21	158
2008	4	37	29	238
2009	4	108	0	294
2010	7	33	10	393
2011	11	90	11	486
2012	7	86	10	542
2013	12	120	0	818
2014	7	89	1	1,066
2015	8	129	0	1,170
2016	10	114	1	970
2017	7	120	4	1,681
2018	4	152	1	1,545
2019	9	106	2	1,728
2020	3	98	5	1,567
2021	5	151	0	1,358
2022	5	158	0	1,268
2023	4	250	2	1,750
2024	2	—	0	2,122
2025	3	97	0	2,281
2026	2	—	1	—

https://510kreport.com/device/K010124 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010124: Arthrex Univers 30 Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010124

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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