510(k) · Cleared

Cleared

Cofield Total Shoulder System

K070565510(k) AbbreviatedCleared May 18, 200779-day reviewClass II21 CFR 888.3670

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

Smith & Nephew, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on May 18, 2007 as substantially equivalent to K955767 (Smith & Nephew Richards, Inc., 1996) and 3 other predicates after a 79-day review. Its family tree reaches back 4 generations to 1980. 26 later devices descend from it.

Decided: May 18, 2007
Review: 79 days
Class: Class II
Product code: MBF
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K800494 (1980). 20 ancestors in all. 26 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
3 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
2 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
1 generation backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
This deviceK070565 Cofield Total Shoulder SystemSmith & Nephew, Inc. · 2007
Descendant · cites it directly · 24 of its ownK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
Descendant · 2 generations on · 22 of its ownK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
Descendant · 3 generations on · 21 of its ownK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
Descendant · 4 generations on · 20 of its ownK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
Descendant · 5 generations on · 16 of its ownK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2010high 4 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 26 · See all

K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc. · 2010 · cites it directly24descendants
K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · 2 generations on22descendants
K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc. · 2011 · 3 generations on21descendants
K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc. · 2012 · 4 generations on20descendants
K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015 · 5 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K800494	New Jersey Hemiarthroplasty Sholder Pros	Depuy, Inc.	1980	—
−3	K991585	Bipolar Shoulder Prosthesis	Biomet, Inc.	1999	—
−2	K002998	Biomet BI-Polar Shoulder System	Biomet, Inc.	2000	1
−1	K030710	Bio-Modular Shoulder System	Biomet, Inc.	2003	1
0 (this device)	K070565	Cofield Total Shoulder System	Smith & Nephew, Inc.	2007	—
+1	K093430	Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage…	Exactech, Inc.	2010	1
+2	K103419	Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM	Exactech, Inc.	2010	2
+3	K111379	Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…	Exactech, Inc.	2011	2
+4	K121220	Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right	Exactech, Inc.	2012	2
+5	K150583	Aequalis PerFORM+ Shoulder System	Tornier, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1987	1	0
1991	1	0
1992	2	0
1994	1	0
1995	1	0
1996	1	0
1998	2	0
1999	3	0
2001	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K070565, 1980–2026Source: 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 MBF? 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 MBF device

#1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 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? (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
*	K955767	Cofied Modular Shoulder System Summary page 1 …the currently marketed components is the intended use of the system without bone cement. Substantially Equivalent Cofield 2 Total Shoulder System - Smith & Nephew (K955767) Cofield 2 Eccentric and Lateral Offset Humeral Heads - Smith & Nephew (K003566) Globalm Fx Porous-Coated Humeral Stem - Depu…	Smith & Nephew Richards, Inc.	1996	—
*	K003566	Cofield Eccentric and Lateral Offset Humeral Heads Summary page 1 …cement. Substantially Equivalent Cofield 2 Total Shoulder System - Smith & Nephew (K955767) Cofield 2 Eccentric and Lateral Offset Humeral Heads - Smith & Nephew (K003566) Globalm Fx Porous-Coated Humeral Stem - Depuy Orthopaedics (KOI 1099) Bio-Modular® Shoulder System Biomet Orthopedics (K0307…	Smith & Nephew, Inc.	2001	—
*	K011099	Global FX Porous-Coated Humeral Stem	DePuy Orthopaedics, Inc.	2001	—
*	K030710	Bio-Modular Shoulder System Summary page 1 …ffset Humeral Heads - Smith & Nephew (K003566) Globalm Fx Porous-Coated Humeral Stem - Depuy Orthopaedics (KOI 1099) Bio-Modular® Shoulder System Biomet Orthopedics (K030710) Ii]III I fi iM 111 iilIhlB IlBl IIII I11[111 11111111 DEPARTMENT…	Biomet, Inc.	2003	1

Also cleared against K955767: 4 other devices →

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K093430	Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…	Exactech, Inc.	2010	24
K121714	Smith & Nephew, Inc. Shoulder System Instruments	Smith & Nephew, Inc.	2012	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?

The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
3 of the 20 ancestors have a recall of any class.
Of its descendants, K093430 (Exactech, Inc., 2010) has gone furthest, with 24 descendants of its own.
4 other devices also cite its predicate K955767.

How does its category compare?

All MBF devices

MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MBF

2in 2025

2007high 4 (2022) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBF

144in 2023

2007high 164 (2022) · low 144 (2023)2026

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

Recalls per year · MBF

1in 2023

2007high 8 (2022) · low 0 (2007)2026

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

Adverse event reports per year · MBF

255in 2025

2007high 255 (2025) · low 2 (2007)2025

MAUDE reports naming product code MBF, 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	—	0	2
2008	1	—	0	7
2009	1	—	1	16
2010	0	—	0	24
2011	0	—	0	32
2012	2	—	0	30
2013	1	—	0	40
2014	1	—	0	28
2015	0	—	0	49
2016	0	—	0	85
2017	2	—	1	193
2018	1	—	1	99
2019	2	—	2	47
2020	2	—	0	24
2021	1	—	0	36
2022	4	164	8	114
2023	4	144	1	143
2024	2	—	0	164
2025	2	—	0	255
2026	1	—	0	—

What is it indicated for?

The Cofield2 Total Shoulder System is indicated for the following: Proximal Humeral Prosthesis 1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification or head splitting, or head impression fractures). 2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union of a small osteoporotic head fragment, or chronic dislocation with…

Read the full statement (168 words)

The Cofield2 Total Shoulder System is indicated for the following:

Proximal Humeral Prosthesis

1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification or head splitting, or head impression fractures).

2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.

3. Avascular necrosis with intact glenoid cartilage.

4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.

Total Shoulder Arthroplasty

Severe destruction of the glenohumerat articular surfaces with intractable chronic pain in rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.

The Cofield2 Total Shoulder System includes porous coated devices which are intended for use without bone cement, and are single use devices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070565 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070565: Cofield Total 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/K070565

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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