510(k) · Cleared
Cleared3-Piece Proximal Humeral Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jan 30, 2002 as substantially equivalent to K925613 (Biomet, Inc., 1994) after a 23-day review. Its family tree reaches back 1 generation to 1994. 17 later devices descend from it.
- Decided
- Jan 30, 2002
- Review
- 23 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925613 (1994). 17 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK925613 Proximal Humeral Replacement SystemBiomet, Inc. · 1994
- This deviceK020045 3-Piece Proximal Humeral Replacement SystemBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 16 of its ownK022079 Short and Long Soft Tissue AttachmentBiomet, Inc. · 2002
- Descendant · cites it directly · 15 of its ownK033280 Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 9 of its ownK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
- Descendant · cites it directly · 8 of its ownK043505 Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K022079Short and Long Soft Tissue AttachmentBiomet, Inc. · 2002 · cites it directly16descendants
- K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · cites it directly15descendants
- K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005 · 2 generations on9descendants
- K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005 · cites it directly8descendants
- K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925613 | Proximal Humeral Replacement System | Biomet, Inc. | 1994 | — |
| 0 (this device) | K020045 | 3-Piece Proximal Humeral Replacement System | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K022079 | Short and Long Soft Tissue Attachment | Biomet, Inc. | 2002 | — |
| +1 | K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement System | Biomet, Inc. | 2003 | 1 |
| +2 | K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head | Biomet Manufacturing Corp | 2005 | — |
| +1 | K043505 | Discovery-Mosaic Total Humerus System | Biomet, Inc. | 2005 | — |
| +1 | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 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), 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? (1)
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 |
|---|---|---|---|
| * | K925613 | Proximal Humeral Replacement SystemSummary page 1…to which Substantially Equivalence is Claimed: The 3- piece Proximal Humeral Replacement System has been developed by modifying the Proximal Humeral Replacement System (K925613). Device Description: The 3-piece Proximal Humeral Replacement System is a total shoulder prosthesis humeral component in cases… | 1994 |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022079 | Short and Long Soft Tissue Attachment | 2002 | 16 |
| K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement System | 2003 | 15 |
| K043505 | Discovery-Mosaic Total Humerus System | 2005 | 8 |
| K111746 | Comprehensive Segmental Revision System (SRS) | 2011 | 7 |
| K112905 | Compress (R) Segmental Humeral Replacement System | 2012 | 5 |
| K042664 | LPS Upper Extremity | 2004 | 0 |
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?
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 indications for use for the 3-Piece Proximal Humeral Replacement System include noninflamatory degenerative joint disease including osteoarthritis and avascular Necrosis, rheumatoid arthritis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, treatment of acute fractures with humeral head involvement which are unmanageable using other treatment methods and oncology applications.
This device is for use with bone cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020045: 3-Piece 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/K020045
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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