510(k) · Cleared

Cleared

Arthrex Univers II Shoulder Prosthesis

K071032510(k) SpecialCleared Aug 20, 2007131-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 Aug 20, 2007 as substantially equivalent to K010124 (Arthrex, Inc., 2001) after a 131-day review. Its family tree reaches back 1 generation to 2001. 21 later devices descend from it.

Decided: Aug 20, 2007
Review: 131 days
Class: Class II
Product code: KWS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010124 (2001). 21 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK010124 Arthrex Univers 30 Shoulder ProsthesisArthrex, Inc. · 2001
This deviceK071032 Arthrex Univers II Shoulder ProsthesisArthrex, Inc. · 2007
Descendant · cites it directly · 8 of its ownK183194 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019
Descendant · cites it directly · 5 of its ownK103466 Arthrex Univers II Shoulder ProsthesisArthrex, Inc. · 2010
Descendant · cites it directly · 5 of its ownK083435 Arthrex Univers II Shoulder Pegged GlenoidArthrex, Inc. · 2009
Descendant · cites it directly · 4 of its ownK131633 Arthrex Univers ApexArthrex, Inc. · 2013
Descendant · 2 generations on · 4 of its ownK120044 Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL…Arthrex, Inc. · 2012

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2009high 4 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 21 · See all

K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019 · cites it directly8descendants
K103466Arthrex Univers II Shoulder ProsthesisArthrex, Inc. · 2010 · cites it directly5descendants
K083435Arthrex Univers II Shoulder Pegged GlenoidArthrex, Inc. · 2009 · cites it directly5descendants
K131633Arthrex Univers ApexArthrex, Inc. · 2013 · cites it directly4descendants
K120044Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-KeeledArthrex, Inc. · 2012 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010124	Arthrex Univers 30 Shoulder Prosthesis	Arthrex, Inc.	2001	—
0 (this device)	K071032	Arthrex Univers II Shoulder Prosthesis	Arthrex, Inc.	2007	—
+1	K183194	Arthrex Eclipse Shoulder Prosthesis System	Arthrex, Inc.	2019	—
+1	K103466	Arthrex Univers II Shoulder Prosthesis	Arthrex, Inc.	2010	—
+1	K083435	Arthrex Univers II Shoulder Pegged Glenoid	Arthrex, Inc.	2009	—
+1	K131633	Arthrex Univers Apex	Arthrex, Inc.	2013	—
+2	K120044	Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-Keeled	Arthrex, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2012	1	0
2013	1	0
2015	1	0
2016	1	0
2018	2	0
2019	2	0
2020	2	0
2021	3	0
2022	1	0
2023	4	0
2024	1	0

FIG. 1 — Lineage of K071032, 2001–2024Source: 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 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? (1)

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
*	K010124	Arthrex Univers 30 Shoulder Prosthesis Summary page 1 …HSD - Prosthesis, Shoulder, hemi-humeral, metal, uncemented Predicate Device Arthrex Shoulder Prosthesis (Univers Shoulder), K010124 Device Description The Arthrex Univers IIShoulder Prosthesis consists of a stem for an…	Arthrex, Inc.	2001	—

Also cleared against K010124: 4 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K183194	Arthrex Eclipse Shoulder Prosthesis System	Arthrex, Inc.	2019	8
K103466	Arthrex Univers II Shoulder Prosthesis	Arthrex, Inc.	2010	5
K083435	Arthrex Univers II Shoulder Pegged Glenoid	Arthrex, Inc.	2009	5
K131633	Arthrex Univers Apex	Arthrex, Inc.	2013	4
K181555	Arthrex Fracture Adapter Hemi Shoulder Prosthesis	Arthrex, Inc.	2018	1
K171841	Arthrex Shoulder System	Arthrex, Inc.	2018	1
K182799	Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads	Arthrex, Inc.	2019	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?

Its one ancestor has no recall.
Of its descendants, K183194 (Arthrex, Inc., 2019) has gone furthest, with 8 descendants of its own.
4 other devices also cite its predicate K010124.

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. 2007, this device’s year, is highlighted.

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	—

What is it indicated for?

The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071032 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071032: Arthrex Univers II 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/K071032

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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