510(k) · Cleared

Cleared

Biomet's Minimally Constrained Elbow

K003253510(k) TraditionalCleared Jan 12, 200187-day reviewClass II21 CFR 888.3150

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

Biomet, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented

Cleared on Jan 12, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided: Jan 12, 2001
Review: 87 days
Class: Class II
Product code: JDC
Recalls: None
Predicates: 0

24 later devices descend from it, 1 citing it directly.

This deviceK003253 Biomet's Minimally Constrained ElbowBiomet, Inc. · 2001
Descendant · cites it directly · 23 of its ownK013042 Discovery ElbowBiomet Orthopedics, Inc. · 2001 · Recalled
Descendant · 2 generations on · 15 of its ownK033280 Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · Recalled
Descendant · 2 generations on · 11 of its ownK051975 Porous Coated Discovery ElbowBiomet, Inc. · 2005 · Recalled
Descendant · 3 generations on · 9 of its ownK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
Descendant · 3 generations on · 8 of its ownK043505 Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2001high 3 (2005) · low 0 (2002)2026

Most influential descendants

Showing 5 of 24 · See all

K013042Discovery ElbowBiomet Orthopedics, Inc. · 2001 · cites it directly23descendants
K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · 2 generations on15descendants
K051975Porous Coated Discovery ElbowBiomet, Inc. · 2005 · 2 generations on11descendants
K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005 · 3 generations on9descendants
K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005 · 3 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003253	Biomet's Minimally Constrained Elbow	Biomet, Inc.	2001	—
+1	K013042	Discovery Elbow	Biomet Orthopedics, Inc.	2001	3
+2	K033280	Discovery Elbow-Mosaic Distal Humeral Replacement System	Biomet, Inc.	2003	1
+2	K051975	Porous Coated Discovery Elbow	Biomet, Inc.	2005	2
+3	K042321	Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head	Biomet Manufacturing Corp	2005	—
+3	K043505	Discovery-Mosaic Total Humerus System	Biomet, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2004	1	0
2005	3	0
2009	1	0
2011	2	0
2012	2	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2019	2	0
2020	1	0
2022	2	0
2023	2	0
2025	2	0

FIG. 1 — Lineage of K003253, 2001–2025Source: 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 JDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

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? (24)

See all 24

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013042	Discovery Elbow	Biomet Orthopedics, Inc.	2001	23

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, K013042 (Biomet Orthopedics, Inc., 2001) has gone furthest, with 23 descendants of its own.

How does its category compare?

All JDC devices

JDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDC

2in 2019

2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDC

Too few JDC 510(k)s in any year since 2007 to give a median.

Recalls per year · JDC

2in 2019

2007high 6 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JDC

212in 2025

2007high 401 (2017) · low 33 (2007)2025

MAUDE reports naming product code JDC, 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	0	—	0	33
2008	0	—	2	47
2009	1	—	6	45
2010	0	—	0	86
2011	0	—	2	62
2012	0	—	2	79
2013	1	—	0	74
2014	0	—	0	79
2015	1	—	0	239
2016	1	—	0	176
2017	0	—	0	401
2018	0	—	0	248
2019	2	—	2	190
2020	0	—	0	179
2021	0	—	0	157
2022	0	—	0	129
2023	0	—	0	189
2024	0	—	0	175
2025	0	—	0	212
2026	0	—	1	—

https://510kreport.com/device/K003253 · printed Nov 3, 2026

Cite this page

510(k) Report. “K003253: Biomet's Minimally Constrained Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003253

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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