510(k) · Cleared

Cleared

WMT Ultra-Fit Modular Shoulder System

K002683510(k) TraditionalCleared Nov 22, 200086-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

Wrightmedicaltechnologyinc · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Nov 22, 2000 as substantially equivalent to K920362 (3M Health Care, Ltd., 1993) after an 86-day review. Its family tree reaches back 1 generation to 1993. 288 later devices descend from it.

Decided: Nov 22, 2000
Review: 86 days
Class: Class II
Product code: KWS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K920362 (1993). 288 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
This deviceK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
Descendant · cites it directly · 287 of its ownK032679 Aequalis Shoulder Fracture SystemTornier · 2003
Descendant · cites it directly · 258 of its ownK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
Descendant · 2 generations on · 257 of its ownK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
Descendant · 3 generations on · 199 of its ownK061439 Aequalis Reversed ProsthesisTornier · 2006
Descendant · 3 generations on · 179 of its ownK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008

Showing 5 of 288 descendants. See all descendants

Descendants cleared per year

2003high 23 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 288 · See all

K032679Aequalis Shoulder Fracture SystemTornier · 2003 · cites it directly287descendants
K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier · 2004 · cites it directly258descendants
K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006 · 2 generations on257descendants
K061439Aequalis Reversed ProsthesisTornier · 2006 · 3 generations on199descendants
K081059Aequalis Reversed Shoulder ProsthesisTornier · 2008 · 3 generations on179descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K920362	3M Modular Shoulder System	3M Health Care, Ltd.	1993	—
0 (this device)	K002683	WMT Ultra-Fit Modular Shoulder System	Wrightmedicaltechnologyinc	2000	—
+1	K032679	Aequalis Shoulder Fracture System	Tornier	2003	—
+1	K043077	Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System	Tornier	2004	—
+2	K060209	Aequalis Shoulder Fracture System & Aequalis Shoulder System	Tornier	2006	—
+3	K061439	Aequalis Reversed Prosthesis	Tornier	2006	—
+3	K081059	Aequalis Reversed Shoulder Prosthesis	Tornier	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2006	7	0
2007	2	0
2008	3	0
2010	7	0
2011	12	0
2012	9	0
2013	8	0
2014	13	0
2015	8	0
2016	13	0
2017	15	0
2018	20	0
2019	21	0
2020	19	0
2021	23	0
2022	23	0
2023	17	0
2024	19	0
2025	23	0
2026	23	0

FIG. 1 — Lineage of K002683, 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 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
*	K920362	3M Modular Shoulder System Summary page 2 …al in intended use, type of .interface, material, and design features to the 3M glenoid :component submitted under 3M :Modular Shoulder System (Table 1: K920362, SE 07/22/1993) currently distributed by WMT; and the WMT ULTRA-FITTM Glenoids that are described below. 31…	3M Health Care, Ltd.	1993	—

Also cleared against K920362: 1 other device →

What descends from it? (288)

See all 288

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

Number	Device	Applicant	Decided	Descendants
K032679	Aequalis Shoulder Fracture System	Tornier	2003	287
K043077	Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System	Tornier	2004	258

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, K032679 (Tornier, 2003) has gone furthest, with 287 descendants of its own.
1 other device also cites its predicate K920362.

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	—

What is it indicated for?

The WMT Modular Shoulder is indicated for use in shoulder arthroplasty for reduction or relief of pain and/or improved shoulder function in skeletally mature patients with sufficient and satisfactory bone stock to support the prosthesis with the following conditions: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis or post-traumatic arthritis; Revision where other devices or treatments have…

Read the full statement (110 words)

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

Rheumatoid arthritis or post-traumatic arthritis;

Revision where other devices or treatments have failed;

Correction of functional deformity;

Treatment of acute fracture of the humeral head unmanageable using other treatment methods; and

Cuff tear arthroplasty.

Hemi-shoulder replacement is also indicated for:

Ununited humeral head fractures; and

Avascular necrosis of the humeral head.

The humeral stem may be implanted by press-fit or cement fixation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K002683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002683: WMT Ultra-Fit Modular Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002683

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026