510(k) Report

510(k) · Cleared

Cleared

Discovery-Mosaic Total Humerus System

K043505510(k) TraditionalCleared Feb 9, 200551-day reviewClass II21 CFR 888.3650

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

Biomet, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Cleared on Feb 9, 2005 as substantially equivalent to K033280 (Biomet, Inc., 2003) and 1 other predicate after a 51-day review. Its family tree reaches back 4 generations to 1994. 8 later devices descend from it.

Decided
Feb 9, 2005
Review
51 days
Class
Class II
Product code
KWT
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K925613 (1994). 8 ancestors in all, the oldest K913282 (1991). 8 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 1 other ancestor1991: 1 other ancestor2011: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2018: 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. · 2002K033280 · Discovery Elbow-Mosaic Distal Humeral Replacement System · Biomet, Inc. · 2003 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K033280 · Discovery Elbow-Mosaic Distal Humeral Replacement System · Biomet, Inc. · 2003 · recalledK022079 · 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 · 4 generations backK925613 Proximal Humeral Replacement SystemBiomet, Inc. · 1994
  2. 3 generations backK020045 3-Piece Proximal Humeral Replacement SystemBiomet Orthopedics, Inc. · 2002
  3. 2 generations backK022079 Short and Long Soft Tissue AttachmentBiomet, Inc. · 2002
  4. 1 generation backK033280 Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · Recalled
  5. This deviceK043505 Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005
  6. Descendant · cites it directly · 7 of its ownK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
  7. Descendant · 2 generations on · 5 of its ownK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
  8. Descendant · 2 generations on · 3 of its ownK153398 Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016
  9. Descendant · 2 generations on · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
  10. Descendant · 3 generations on · 1 of its ownK223631 Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011: 12015: 12016: 12017: 12018: 12023: 12025: 2
2011high 2 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 8 · See all
  • K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · cites it directly7descendants
  • K143659Equinoxe Mega ProsthesisExactech, Inc. · 2015 · 2 generations on5descendants
  • K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016 · 2 generations on3descendants
  • K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018 · 2 generations on2descendants
  • K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K925613Proximal Humeral Replacement SystemBiomet, Inc.1994—
−3K0200453-Piece Proximal Humeral Replacement SystemBiomet Orthopedics, Inc.2002—
−2K022079Short and Long Soft Tissue AttachmentBiomet, Inc.2002—
−1K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc.20031
0 (this device)K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc.2005—
+1K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.20111
+2K143659Equinoxe Mega ProsthesisExactech, Inc.2015—
+2K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp2016—
+2K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp2018—
+3K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200010
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201510
201610
201710
201810
202310
202520
FIG. 1 — Lineage of K043505, 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 KWT? 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 KWT device

  1. #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K033280Discovery Elbow-Mosaic Distal Humeral Replacement System
Summary page 1
…(21 CER §888.3650) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: DiscoveryTm Elbow - MosaicT-m Distal Humeral Replacement System: K033280 - Biomet Inc. 3 Piece Proxinmal Humneral Replacement System: K020045 - Biomet Inc. Device Descriptio…
Biomet, Inc.20031
*K0200453-Piece Proximal Humeral Replacement System
Summary page 1
…DiscoveryTm Elbow - MosaicT-m Distal Humeral Replacement System: K033280 - Biomet Inc. 3 Piece Proxinmal Humneral Replacement System: K020045 - Biomet Inc. Device Description: The DiscoveryTM - MosaiCTm Total HUMerus System includes the components of the D…
Biomet Orthopedics, Inc.2002—

Also cleared against K033280: 4 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.20117

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 11 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K111746 (Biomet, Inc., 2011) has gone furthest, with 7 descendants of its own.
  • 4 other devices also cite its predicate K033280.

How does its category compare?

All KWT devices

KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWT

4in 2025

2007: 12010: 12011: 52012: 12013: 12014: 12015: 22016: 22017: 12018: 22019: 42020: 12021: 12022: 12023: 12024: 12025: 42026 (partial year): 1
2007high 5 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWT

242in 2025

2011: 165 days median2019: 91 days median2025: 242 days median
2007high 242 (2025) · low 91 (2019)2026

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

Recalls per year · KWT

1in 2023

2008: 12010: 72012: 22013: 12016: 12017: 12018: 12019: 32023: 1
2007high 7 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWT

749in 2025

2007: 322008: 482009: 582010: 712011: 1122012: 832013: 1132014: 1682015: 1762016: 4452017: 5602018: 4802019: 4192020: 2152021: 2282022: 2732023: 3612024: 6012025: 749
2007high 749 (2025) · low 32 (2007)2025

MAUDE reports naming product code KWT, 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
20071—032
20080—148
20090—058
20101—771
201151650112
20121—283
20131—1113
20141—0168
20152—0176
20162—1445
20171—1560
20182—1480
20194913419
20201—0215
20211—0228
20221—0273
20231—1361
20241—0601
202542420749
20261—0—

What is it indicated for?

The indications for use for the Discovery - Mosaic Total Humerus System include:

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 or chronic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods

6. Oncology applications

The Discovery - Mosaic Total Humerus System is intended for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K033280

4 other devices cite the same predicate.

  • K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 20122 recalls
  • K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 20111 recall
  • K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
  • K042664LPS Upper ExtremityDepuy, Inc. · 2004

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 KWT

The KWT category page

  • K262173N22 Offset Humeral HeadShoulder Innovations, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 20251 recall
  • K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2025
  • K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025

https://510kreport.com/device/K043505 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043505: Discovery-Mosaic Total Humerus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043505

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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