510(k) · Cleared

Cleared

Cofield Eccentric and Lateral Offset Humeral Heads

K003566510(k) TraditionalCleared Feb 14, 200186-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

Smith & Nephew, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Feb 14, 2001 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.

Decided: Feb 14, 2001
Review: 86 days
Class: Class II
Product code: KWS
Recalls: None
Predicates: 0

28 later devices descend from it, 3 citing it directly.

This deviceK003566 Cofield Eccentric and Lateral Offset Humeral HeadsSmith & Nephew, Inc. · 2001
Descendant · cites it directly · 26 of its ownK070565 Cofield Total Shoulder SystemSmith & Nephew, Inc. · 2007
Descendant · 2 generations on · 24 of its ownK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
Descendant · 3 generations on · 22 of its ownK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
Descendant · 4 generations on · 21 of its ownK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
Descendant · 5 generations on · 20 of its ownK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2003high 4 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 28 · See all

K070565Cofield Total Shoulder SystemSmith & Nephew, Inc. · 2007 · cites it directly26descendants
K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc. · 2010 · 2 generations on24descendants
K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · 3 generations on22descendants
K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc. · 2011 · 4 generations on21descendants
K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc. · 2012 · 5 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003566	Cofield Eccentric and Lateral Offset Humeral Heads	Smith & Nephew, Inc.	2001	—
+1	K070565	Cofield Total Shoulder System	Smith & Nephew, Inc.	2007	—
+2	K093430	Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage…	Exactech, Inc.	2010	1
+3	K103419	Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM	Exactech, Inc.	2010	2
+4	K111379	Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…	Exactech, Inc.	2011	2
+5	K121220	Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right	Exactech, Inc.	2012	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2007	1	0
2010	2	0
2011	2	0
2012	2	0
2015	1	0
2016	2	0
2018	3	0
2019	2	0
2022	2	0
2023	4	0
2024	1	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K003566, 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? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K070565	Cofield Total Shoulder System	Smith & Nephew, Inc.	2007	26
K121714	Smith & Nephew, Inc. Shoulder System Instruments	Smith & Nephew, Inc.	2012	0
K030344	Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral Heads	Smith & Nephew, Inc.	2003	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?

Of its descendants, K070565 (Smith & Nephew, Inc., 2007) has gone furthest, with 26 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/K003566 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003566: Cofield Eccentric and Lateral Offset Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003566

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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