510(k) · Cleared
Recalled · Class II · 2017Bio-Modular Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Sep 13, 1999 after an 82-day review. The FDA summary names its predicate without a number. 1 of the 420 devices in its family, counting itself, has a Class I recall. 419 later devices descend from it. It has been recalled once.
- Decided
- Sep 13, 1999
- Review
- 82 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 0
419 later devices descend from it, 13 citing it directly. 1 of the 420 devices in this family, counting this one, has a Class I recall.
- This deviceK992119 Bio-Modular Shoulder SystemBiomet, 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 · 2 generations on · 280 of its ownK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · 2 generations on · 277 of its ownK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · cites it directly · 253 of its ownK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
Showing 5 of 419 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations on · 2008
Most influential descendants
Showing 5 of 419 · 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 · 2 generations on280descendants
- K041873Aequalis Reversed Shoulder ProsthesisTornier · 2004 · 2 generations on277descendants
- K030710Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · cites it directly253descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992119 | Bio-Modular Shoulder System | Biomet, Inc. | 1999 | — |
| +1 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| +2 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| +2 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +2 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +1 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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 |
|---|---|---|---|
| * | — | Integrated Shoulder System (Kirschner) Named without a submission number | |
| * | — | Global Shoulder (DePuy) Named without a submission number | |
| * | — | Foundation Shoulder System (Encore Orthopedics) Named without a submission number |
What descends from it? (419)
See all 41913 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 |
| K030710 | Bio-Modular Shoulder System | 2003 | 253 |
| K041549 | Zimmer Trabecular Metal Humeral Stem | 2004 | 218 |
| K072804 | Comprehensive RS Shoulder System | 2007 | 175 |
| K023063 | Comprehensive Humeral Fracture System | 2002 | 146 |
| K010827 | Copeland MB/HA Resurfacing Humeral Heads | 2001 | 142 |
| K010657 | Copeland MB Resurfacing Humeral Heads | 2001 | 136 |
| K032507 | Interlok Bio-Modular Humeral Stems | 2003 | 123 |
| K071147 | Nexa Orthopedics Total Shoulder System | 2007 | 120 |
| K060694 | Modular Hybrid Glenoid | 2006 | 57 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2017 | Class II | Z-1859-2017 | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. |
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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021478 (Depuy, Inc., 2003) has gone furthest, with 338 descendants of its own.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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
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/K992119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992119: Bio-Modular Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992119
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