510(k) · Cleared

Cleared

Bio-Modular Shoulder Offset Humeral Heads

K992899510(k) TraditionalCleared Oct 21, 199952-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

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

Cleared on Oct 21, 1999 as substantially equivalent to K872454 (Biomet, Inc., 1987) and 2 other predicates after a 52-day review. Its family tree reaches back 1 generation to 1987. 1 of the 258 devices in its family, counting itself, has a Class I recall. 254 later devices descend from it.

Decided: Oct 21, 1999
Review: 52 days
Class: Class II
Product code: KWS
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K872454 (1987). 3 ancestors in all. 254 later devices descend from it, 3 citing it directly. 1 of the 258 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK872454 Biomet Modular Shoulder ProsthesisBiomet, Inc. · 1987
This deviceK992899 Bio-Modular Shoulder Offset Humeral HeadsBiomet, Inc. · 1999
Descendant · cites it directly · 253 of its ownK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
Descendant · 2 generations on · 176 of its ownK043100 Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid…Biomet, Inc. · 2005 · Recalled
Descendant · 2 generations on · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
Descendant · 3 generations on · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
Descendant · 2 generations on · 138 of its ownK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled

Showing 5 of 254 descendants. See all descendants

Descendants cleared per year

2003high 24 (2021) · low 1 (2004)2026

Class I recalls in this family

K080642 Comprehensive Reverse Shoulder3 generations on · 2008

Most influential descendants

Showing 5 of 254 · See all

K030710Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · cites it directly253descendants
K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc. · 2005 · 2 generations on176descendants
K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007 · 2 generations on175descendants
K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations on172descendants
K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · 2 generations on138descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K872454	Biomet Modular Shoulder Prosthesis	Biomet, Inc.	1987	—
0 (this device)	K992899	Bio-Modular Shoulder Offset Humeral Heads	Biomet, Inc.	1999	—
+1	K030710	Bio-Modular Shoulder System	Biomet, Inc.	2003	1
+2	K043100	Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components	Biomet, Inc.	2005	1
+2	K072804	Comprehensive RS Shoulder System	Biomet Manufacturing Corp	2007	—
+3	K080642	Comprehensive Reverse Shoulder	Biomet, Inc.	2008	Class I
+2	K060692	Comprehensive Primary Shoulder Stems	Biomet Manufacturing Corp	2006	6

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2005	3	0
2006	4	0
2007	4	0
2008	2	1
2009	1	0
2010	5	0
2011	9	0
2012	12	0
2013	9	0
2014	9	0
2015	6	0
2016	10	0
2017	13	0
2018	15	0
2019	18	0
2020	18	0
2021	24	0
2022	20	0
2023	17	0
2024	14	0
2025	19	0
2026	19	0

FIG. 1 — Lineage of K992899, 1987–2026Source: 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.

1 device in this family has a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K872454	Biomet Modular Shoulder Prosthesis Summary page 2 …ds are substantially equivalent to other shoulder devices on the market. Specifically, the device may be compared to : Bio-Modular Shoulder System (Biomet, Inc.) 510(k) K872454 Aequalis Shoulder Prosthesis (Tornier, Inc.) 510(k) K952928 Global Dialable Eccentric Head (DePuy) 510(k) K974044…	Biomet, Inc.	1987	—
*	K952928	Aequalis Shoulder System for Total & Hemishoulder Applications Summary page 2 …the market. Specifically, the device may be compared to : Bio-Modular Shoulder System (Biomet, Inc.) 510(k) K872454 Aequalis Shoulder Prosthesis (Tornier, Inc.) 510(k) K952928 Global Dialable Eccentric Head (DePuy) 510(k) K974044 L $8RVICe, > %, _/é DEPARTMENT OF HEALTH & HUMAN SERVICES…	Tornier	1995	—
*	K974044	Global Total Shoulder Eccentric Humeral Head Summary page 2 …to : Bio-Modular Shoulder System (Biomet, Inc.) 510(k) K872454 Aequalis Shoulder Prosthesis (Tornier, Inc.) 510(k) K952928 Global Dialable Eccentric Head (DePuy) 510(k) K974044 L $8RVICe, > %, _/é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9…	DePuy Orthopaedics, Inc.	1998	—

Also cleared against K872454: 3 other devices →

What descends from it? (254)

See all 254

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

Number	Device	Applicant	Decided	Descendants
K030710	Bio-Modular Shoulder System	Biomet, Inc.	2003	253
K071147	Nexa Orthopedics Total Shoulder System	Nexa Orthopedics, Inc.	2007	120
K042321	Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head	Biomet Manufacturing Corp	2005	9

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K030710 (Biomet, Inc., 2003) has gone furthest, with 253 descendants of its own.
3 other devices also cite its predicate K872454.

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?

1) Non-inflammatory degenerative joint disease including

osteoarthritis and avascular necrosis.

2) Rheumatoid arthritis

3) Revision where other devices or treatments have failed

4) Correction of functional deformity

5) Treatment of acute fracture of the humeral head unmanageable using

other treatment methods.

6) Cuff tear arthropathy

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992899 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992899: Bio-Modular Shoulder Offset Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992899

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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