510(k) · Cleared
ClearedProximal Humeral Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Oct 14, 1994 after a 708-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Oct 14, 1994
- Review
- 708 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK925613 Proximal Humeral Replacement SystemBiomet, Inc. · 1994
- Descendant · cites it directly · 17 of its ownK020045 3-Piece Proximal Humeral Replacement SystemBiomet Orthopedics, Inc. · 2002
- Descendant · 2 generations on · 16 of its ownK022079 Short and Long Soft Tissue AttachmentBiomet, Inc. · 2002
- Descendant · 2 generations on · 15 of its ownK033280 Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · Recalled
- Descendant · cites it directly · 10 of its ownK032895 BI-Angular Shoulder SystemBiomet, Inc. · 2003
- Descendant · 2 generations on · 9 of its ownK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K0200453-Piece Proximal Humeral Replacement SystemBiomet Orthopedics, Inc. · 2002 · cites it directly17descendants
- K022079Short and Long Soft Tissue AttachmentBiomet, Inc. · 2002 · 2 generations on16descendants
- K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · 2 generations on15descendants
- K032895BI-Angular Shoulder SystemBiomet, Inc. · 2003 · cites it directly10descendants
- K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925613 | Proximal Humeral Replacement System | Biomet, Inc. | 1994 | — |
| +1 | K020045 | 3-Piece Proximal Humeral Replacement System | Biomet Orthopedics, Inc. | 2002 | — |
| +2 | K022079 | Short and Long Soft Tissue Attachment | Biomet, Inc. | 2002 | — |
| +2 | K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement System | Biomet, Inc. | 2003 | 1 |
| +1 | K032895 | BI-Angular Shoulder System | Biomet, Inc. | 2003 | — |
| +2 | K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head | Biomet Manufacturing Corp | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 193 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?
- Of its descendants, K020045 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 17 descendants of its own.
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 | — |
https://510kreport.com/device/K925613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925613: Proximal 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/K925613
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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