510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Discovery Elbow-Mosaic Distal Humeral Replacement System

K033280510(k) TraditionalCleared Dec 19, 200370-day reviewClass II21 CFR 888.3150Recalls 1

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 Dec 19, 2003 as substantially equivalent to K013042 (Biomet Orthopedics, Inc., 2001) and 3 other predicates after a 70-day review. Its family tree reaches back 3 generations to 1994. 15 later devices descend from it. It has been recalled once.

Decided
Dec 19, 2003
Review
70 days
Class
Class II
Product code
JDC
Recalls
1
Predicates
4

Its longest line of descent runs back 3 generations to K925613 (1994). 7 ancestors in all, the oldest K913282 (1991). 15 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 1 other ancestor1991: 1 other ancestor2004: 1 descendant cleared2005: 2 descendants cleared2011: 2 descendants cleared2012: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2025: 2 descendants cleared2017: 1 descendant cleared2023: 1 descendant clearedK925613 · Proximal Humeral Replacement System · Biomet, Inc. · 1994K020045 · 3-Piece Proximal Humeral Replacement System · Biomet Orthopedics, Inc. · 2002K022079 · Short and Long Soft Tissue Attachment · Biomet, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K022079 · Short and Long Soft Tissue Attachment · Biomet, Inc. · 2002K020045 · 3-Piece Proximal Humeral Replacement System · Biomet Orthopedics, Inc. · 2002K925613 · Proximal Humeral Replacement System · Biomet, Inc. · 19940
  1. Root · 3 generations backK925613 Proximal Humeral Replacement SystemBiomet, Inc. · 1994
  2. 2 generations backK020045 3-Piece Proximal Humeral Replacement SystemBiomet Orthopedics, Inc. · 2002
  3. 1 generation backK022079 Short and Long Soft Tissue AttachmentBiomet, Inc. · 2002
  4. This deviceK033280 Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003
  5. Descendant · cites it directly · 9 of its ownK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
  6. Descendant · cites it directly · 8 of its ownK043505 Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005
  7. Descendant · cites it directly · 7 of its ownK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
  8. Descendant · 2 generations on · 5 of its ownK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
  9. Descendant · cites it directly · 5 of its ownK112905 Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22011: 22012: 22015: 12016: 12017: 12018: 12019: 12023: 12025: 2
2004high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 15 · See all
  • K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005 · cites it directly9descendants
  • K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005 · cites it directly8descendants
  • K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · cites it directly7descendants
  • K143659Equinoxe Mega ProsthesisExactech, Inc. · 2015 · 2 generations on5descendants
  • K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K925613Proximal Humeral Replacement SystemBiomet, Inc.1994—
−2K0200453-Piece Proximal Humeral Replacement SystemBiomet Orthopedics, Inc.2002—
−1K022079Short and Long Soft Tissue AttachmentBiomet, Inc.2002—
0 (this device)K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc.2003—
+1K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp2005—
+1K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc.2005—
+1K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.20111
+2K143659Equinoxe Mega ProsthesisExactech, Inc.2015—
+1K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC20122

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200010
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
201120
201220
201510
201610
201710
201810
201910
202310
202520
FIG. 1 — Lineage of K033280, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K013042Discovery Elbow
Summary page 1
…Elbow joint metal/polymer constrained cemented prosthesis (888.3150) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * Discovery TM Elbow (K013042) * Modified Single Axle Total Elbow (K000683) _ 3-Piece Proximal Humeral Replacement System (K020045) * Short and Long Soft Tiss…
Biomet Orthopedics, Inc.20013
*K000683Modified Single Axle Total Elbow
Summary page 1
…cemented prosthesis (888.3150) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * Discovery TM Elbow (K013042) * Modified Single Axle Total Elbow (K000683) _ 3-Piece Proximal Humeral Replacement System (K020045) * Short and Long Soft Tissue Attachment Sleeves (K022079) Device Descri…
Biomet, Inc.2000—
*K0200453-Piece Proximal Humeral Replacement System
Summary page 1
…To Which Substantial Equivalence Is Claimed: * Discovery TM Elbow (K013042) * Modified Single Axle Total Elbow (K000683) _ 3-Piece Proximal Humeral Replacement System (K020045) * Short and Long Soft Tissue Attachment Sleeves (K022079) Device Description: The DiscoveryTM Elbow - MosaicTM Distal Humeral R…
Biomet Orthopedics, Inc.2002—
*K022079Short and Long Soft Tissue Attachment
Summary page 1
…TM Elbow (K013042) * Modified Single Axle Total Elbow (K000683) _ 3-Piece Proximal Humeral Replacement System (K020045) * Short and Long Soft Tissue Attachment Sleeves (K022079) Device Description: The DiscoveryTM Elbow - MosaicTM Distal Humeral Replacement System is an elbow replacement device designed…
Biomet, Inc.2002—

Also cleared against K013042: 4 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp20059
K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc.20058
K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.20117
K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC20125
K042664LPS Upper ExtremityDepuy, Inc.20040

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 28, 2019Class IIZ-1081-2019Process designLack of an adequate sterilization validation

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K042321 (Biomet Manufacturing Corp, 2005) has gone furthest, with 9 descendants of its own.
  • 4 other devices also cite its predicate K013042.

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

2009: 12013: 12015: 12016: 12019: 2
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

2008: 22009: 62011: 22012: 22019: 22026 (partial year): 1
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

2007: 332008: 472009: 452010: 862011: 622012: 792013: 742014: 792015: 2392016: 1762017: 4012018: 2482019: 1902020: 1792021: 1572022: 1292023: 1892024: 1752025: 212
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—033
20080—247
20091—645
20100—086
20110—262
20120—279
20131—074
20140—079
20151—0239
20161—0176
20170—0401
20180—0248
20192—2190
20200—0179
20210—0157
20220—0129
20230—0189
20240—0175
20250—0212
20260—1—

What is it indicated for?

The indications for use for the Discovery TM Elbow - Mosaic TM Distal Humeral Replacement System include:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,

2. Rheumatoid arthritis

3. Revision procedures where other treatments or devices have failed

4. Correction of functional deformity

5. Treatment of acute and chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods

6. Oncology applications

This device is intended to be used with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K013042

4 other devices cite the same predicate.

  • K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P. · 2020
  • K181362TEMA Elbow SystemLima Corporate S.P.A. · 20191 recall
  • K090473Discovery Elbow - X-SmallBiomet Manufacturing Corp · 2009
  • K051975Porous Coated Discovery ElbowBiomet, Inc. · 20052 recalls

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in JDC

The JDC category page

  • K181362TEMA Elbow SystemLima Corporate S.P.A. · 20191 recall
  • K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019
  • K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016
  • K150501Zimmer Nexel Total Elbow Ulnar Cement DiverterZimmer, Inc. · 2015
  • K123862Zimmer Nexel Total ElbowZimmer, Inc. · 2013

https://510kreport.com/device/K033280 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033280

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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