510(k) · Cleared
ClearedBipolar Shoulder Prosthesis
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 18, 1999 as substantially equivalent to K800494 (Depuy, Inc., 1980) and 1 other predicate after a 103-day review. Its family tree reaches back 1 generation to 1980. 1 of the 417 devices in its family, counting itself, has a Class I recall. 414 later devices descend from it.
- Decided
- Aug 18, 1999
- Review
- 103 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K800494 (1980). 2 ancestors in all. 414 later devices descend from it, 7 citing it directly. 1 of the 417 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- This deviceK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- Descendant · cites it directly · 338 of its ownK021478 Delta ShoulderDepuy, Inc. · 2003
- Descendant · 2 generations on · 295 of its ownK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 280 of its ownK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · cites it directly · 277 of its ownK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · cites it directly · 265 of its ownK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
Showing 5 of 414 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations on · 2008
Most influential descendants
Showing 5 of 414 · See all- K021478Delta ShoulderDepuy, Inc. · 2003 · cites it directly338descendants
- K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006 · 2 generations on295descendants
- K030941Aequalis Reversed Shoulder ProsthesisTornier · 2004 · cites it directly280descendants
- K041873Aequalis Reversed Shoulder ProsthesisTornier · 2004 · cites it directly277descendants
- K002998Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · cites it directly265descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| 0 (this device) | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| +1 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| +2 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +1 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +1 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 11 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 1 |
| 2009 | 2 | 0 |
| 2010 | 9 | 0 |
| 2011 | 16 | 0 |
| 2012 | 20 | 0 |
| 2013 | 21 | 0 |
| 2014 | 18 | 0 |
| 2015 | 15 | 0 |
| 2016 | 18 | 0 |
| 2017 | 21 | 0 |
| 2018 | 24 | 0 |
| 2019 | 26 | 0 |
| 2020 | 25 | 0 |
| 2021 | 32 | 0 |
| 2022 | 24 | 0 |
| 2023 | 23 | 0 |
| 2024 | 20 | 0 |
| 2025 | 27 | 0 |
| 2026 | 28 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K800494 | New Jersey Hemiarthroplasty Sholder ProsSummary page 2…hesis is equivalent to other commercially available shoulder hemi-arthroplasties currently on the market. These devices include: New Jersey Hemi Shoulder (DePuy, 510(k) K800494) Monospherical Shoulder (Howmedica, 51 0(k) K802123) H-J-B Shoulder (Richards, pre-amendment) Shoulder Prosthesis (Zimmer, pre-a… | 1980 |
| * | K802123 | Monospherical Shoulder ProsthesisSummary page 2…shoulder hemi-arthroplasties currently on the market. These devices include: New Jersey Hemi Shoulder (DePuy, 510(k) K800494) Monospherical Shoulder (Howmedica, 51 0(k) K802123) H-J-B Shoulder (Richards, pre-amendment) Shoulder Prosthesis (Zimmer, pre-amendment) Neer II Total Shoulder System (3M, pre-am… | 1980 |
| * | — | H-J-B Shoulder Named without a submission number | |
| * | — | Shoulder Prosthesis Named without a submission number | |
| * | — | Neer II Total Shoulder System Named without a submission number |
What descends from it? (414)
See all 4147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021478 | Delta Shoulder | 2003 | 338 |
| K030941 | Aequalis Reversed Shoulder Prosthesis | 2004 | 280 |
| K041873 | Aequalis Reversed Shoulder Prosthesis | 2004 | 277 |
| K002998 | Biomet BI-Polar Shoulder System | 2000 | 265 |
| K050316 | Aequalis Reversed Shoulder Prosthesis | 2005 | 248 |
| K010827 | Copeland MB/HA Resurfacing Humeral Heads | 2001 | 142 |
| K010657 | Copeland MB Resurfacing Humeral Heads | 2001 | 136 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K021478 (Depuy, Inc., 2003) has gone furthest, with 338 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 | — |
What is it indicated for?
Biomet’s Bipolar Shoulder Prosthesis is indicated for use in most cases where a conventional shoulder arthroplasty would be indicated, Typical indications include osteoarthritis, avascular necrosis, traumatic arthritis, rheumatoid arthritis, correction of severe functional deformity, revigion proccdurcs where other treatments or devices have failed, fracture, and cuff tear arthropathy.
This device is a single use implant intended for cemented application only. It is intended for use with Biomet’s humeral componcats provivusly cleared by the FDA tor cemented application.
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/K991585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991585: Bipolar Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991585
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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