510(k) · Cleared
ClearedCocr BI-Angular Humeral Component
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 Aug 5, 1996 as substantially equivalent to K940537 (Kirschner Medical Corp., 1995) and 2 other predicates after a 104-day review. Its family tree reaches back 1 generation to 1987. 147 later devices descend from it.
- Decided
- Aug 5, 1996
- Review
- 104 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K872454 (1987). 3 ancestors in all. 147 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK872454 Biomet Modular Shoulder ProsthesisBiomet, Inc. · 1987
- This deviceK961571 Cocr BI-Angular Humeral ComponentBiomet, Inc. · 1996
- Descendant · cites it directly · 146 of its ownK023063 Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 138 of its ownK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
- Descendant · 3 generations on · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
- Descendant · 4 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 98 of its ownK120794 Ascend Shoulder SystemTornier, Inc. · 2012
Showing 5 of 147 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 147 · See all- K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. · 2002 · cites it directly146descendants
- K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · 2 generations on138descendants
- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · 3 generations on110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 4 generations on108descendants
- K120794Ascend Shoulder SystemTornier, Inc. · 2012 · 3 generations on98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872454 | Biomet Modular Shoulder Prosthesis | Biomet, Inc. | 1987 | — |
| 0 (this device) | K961571 | Cocr BI-Angular Humeral Component | Biomet, Inc. | 1996 | — |
| +1 | K023063 | Comprehensive Humeral Fracture System | Biomet Orthopedics, Inc. | 2002 | 2 |
| +2 | K060692 | Comprehensive Primary Shoulder Stems | Biomet Manufacturing Corp | 2006 | 6 |
| +3 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +4 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K120794 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 16 | 0 |
| 2023 | 13 | 0 |
| 2024 | 11 | 0 |
| 2025 | 15 | 0 |
| 2026 | 15 | 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? (3)
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 |
|---|---|---|---|
| * | K940537 | Kirschner (R) Modular II-C (TM) Total Shoulder SystemSummary page 2…ar Humeral Component is equivalent to almost all shoulder components on the market. Commercially availsble shoulder devices include: Atlas Shoulder, Kirschner, 510(k)# K940537 cleared for marketing 29 August, 1985. Neer Shoulder, Kirschner, 510(k)# K873073 cleared for marketing 1 October, 1987. BirAngul… | 1995 |
| * | K873073 | Kirschner Neer-Iii Proximal HumerusSummary page 2…. Commercially availsble shoulder devices include: Atlas Shoulder, Kirschner, 510(k)# K940537 cleared for marketing 29 August, 1985. Neer Shoulder, Kirschner, 510(k)# K873073 cleared for marketing 1 October, 1987. BirAngular Shoulder, Biomet, 510(k)# KB872454 cleared for marketing 27 August, 1987. 060… | 1987 |
| * | K872454 | Biomet Modular Shoulder ProsthesisSummary page 2…# K940537 cleared for marketing 29 August, 1985. Neer Shoulder, Kirschner, 510(k)# K873073 cleared for marketing 1 October, 1987. BirAngular Shoulder, Biomet, 510(k)# KB872454 cleared for marketing 27 August, 1987. 0600624 Reported Complication of Total Shoulder Arthroplasty Compl icat… | 1987 |
What descends from it? (147)
See all 1471 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023063 | Comprehensive Humeral Fracture System | 2002 | 146 |
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 | — |
https://510kreport.com/device/K961571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961571: Cocr BI-Angular Humeral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961571
Report an extraction error
Are you the manufacturer?
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