510(k) · Cleared
Recalled · 2004Biomet BI-Polar Shoulder 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 6, 2000 as substantially equivalent to K991585 (Biomet, Inc., 1999) after a 10-day review. Its family tree reaches back 2 generations to 1980. 1 of the 269 devices in its family, counting itself, has a Class I recall. 265 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 2000
- Review
- 10 days
- Class
- Class II
- Product code
- KWT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K800494 (1980). 3 ancestors in all. 265 later devices descend from it, 4 citing it directly. 1 of the 269 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 1 generation backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- This deviceK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000
- Descendant · cites it directly · 253 of its ownK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 176 of its ownK043100 Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid…Biomet, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
- Descendant · 3 generations on · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- Descendant · cites it directly · 142 of its ownK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
Showing 5 of 265 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 265 · See all- K030710Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · cites it directly253descendants
- K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc. · 2005 · 2 generations on176descendants
- K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007 · 2 generations on175descendants
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations on172descendants
- K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · cites it directly142descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −1 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| 0 (this device) | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | — |
| +1 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| +2 | K043100 | Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components | Biomet, Inc. | 2005 | 1 |
| +2 | K072804 | Comprehensive RS Shoulder System | Biomet Manufacturing Corp | 2007 | — |
| +3 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| +1 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 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 |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 1 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 9 | 0 |
| 2012 | 12 | 0 |
| 2013 | 12 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 10 | 0 |
| 2017 | 13 | 0 |
| 2018 | 15 | 0 |
| 2019 | 18 | 0 |
| 2020 | 18 | 0 |
| 2021 | 24 | 0 |
| 2022 | 21 | 0 |
| 2023 | 17 | 0 |
| 2024 | 14 | 0 |
| 2025 | 19 | 0 |
| 2026 | 19 | 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? (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 |
|---|---|---|---|
| * | K991585 | Bipolar Shoulder ProsthesisSummary page 2…on Implant loosening/migration Fractureof the components Excessivewear Tissuegrowth failure Nervedamage Predicate Device(s): BiometR Bi-Polar Shoulder,K991585 000172 e“” “m”t. 5' DEPARTMENT OF HEALTH & HUMAN SERVICES Public Healt… | 1999 |
What descends from it? (265)
See all 2654 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2004 | Not classified | Z-0777-04 | Other | The locking ring was not included and the shoulder implanted without the locking ring. |
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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 19.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030710 (Biomet, Inc., 2003) has gone furthest, with 253 descendants of its own.
- 6 other devices also cite its predicate K991585.
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 Biomet® Bi-Polar Shoulder System is indicated for use in:
1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2) Rheumatoid arthritis
3) Revision where other devices or treatments have failed
4) Correction of functional deformity
5) Treatment of acute fracture of the humeral head unmanageable using other treatment methods
6) Cuff tear arthroplasty
This is a single use implant for use with cemented or uncemented humeral components. It is intended for use with Biomet’s humeral components previously cleared by the FDA.
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/K002998 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002998: Biomet BI-Polar Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002998
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026