510(k) · Cleared
ClearedMosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jan 28, 2005 as substantially equivalent to K030710 (Biomet, Inc., 2003) and 3 other predicates after a 155-day review. Its family tree reaches back 5 generations to 1980. 9 later devices descend from it.
- Decided
- Jan 28, 2005
- Review
- 155 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K800494 (1980). 24 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 4 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 3 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 2 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 1 generation backK032895 BI-Angular Shoulder SystemBiomet, Inc. · 2003
- This deviceK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
- Descendant · cites it directly · 7 of its ownK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 5 of its ownK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK153398 Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016
- Descendant · 2 generations on · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
- Descendant · 3 generations on · 1 of its ownK223631 Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −4 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −3 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −2 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −1 | K032895 | BI-Angular Shoulder System | Biomet, Inc. | 2003 | — |
| 0 (this device) | K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head | Biomet Manufacturing Corp | 2005 | — |
| +1 | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet, Inc. | 2011 | 1 |
| +2 | K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | 2015 | — |
| +2 | K153398 | Comprehensive SRS/Nexel Elbow | Biomet Manufacturing Corp | 2016 | — |
| +2 | K173411 | Comprehensive Segmental Revision System (SRS) | Biomet Manufacturing Corp | 2018 | — |
| +3 | K223631 | Comprehensive Segmental Revision System (SRS) | Biomet Orthopedics | 2023 | — |
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 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
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 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K030710 | Bio-Modular Shoulder SystemSummary page 1…ion Name: 1) Shoulder joint metal/polymer non-constrained cemented prosthesis (888.3650) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: *K030710: Bio-Modular® Extended Articular Surface (EAS) Humeral Head (Biomnet) *K032895: 81-Angular® Humeral Head (Biomet) *K033… | 2003 |
| * | K032895 | BI-Angular Shoulder SystemSummary page 1…8.3650) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: *K030710: Bio-Modular® Extended Articular Surface (EAS) Humeral Head (Biomnet) *K032895: 81-Angular® Humeral Head (Biomet) *K033280: Mosaic tM Proximal Humeral Replacement System (Biomet) *K992899: Bio-MVocd… | 2003 |
| * | K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement SystemSummary page 1…antial Equivalence Is Claimed: *K030710: Bio-Modular® Extended Articular Surface (EAS) Humeral Head (Biomnet) *K032895: 81-Angular® Humeral Head (Biomet) *K033280: Mosaic tM Proximal Humeral Replacement System (Biomet) *K992899: Bio-MVocdular® Offset Humeral Head (Biomet)… | 2003 |
| * | K992899 | Bio-Modular Shoulder Offset Humeral HeadsSummary page 1…ticular Surface (EAS) Humeral Head (Biomnet) *K032895: 81-Angular® Humeral Head (Biomet) *K033280: Mosaic tM Proximal Humeral Replacement System (Biomet) *K992899: Bio-MVocdular® Offset Humeral Head (Biomet)… | 1999 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K111746 (Biomet, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 19 other devices also cite its predicate K030710.
How does its category compare?
All KWT devicesKWT 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Heads are for use in primary and revision shoulder joint replacement procedures in cases of:
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Revision where other devices or treatments have failed
* Correction of functional deformity
* Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods
* Oncology applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042321: Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042321
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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