510(k) · Cleared
Recalled · 2008Osteonics Shoulder Humeral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Mar 5, 1996 after a 78-day review. The FDA summary names its predicate without a number. 1 of the 243 devices in its family, counting itself, has a Class I recall. 242 later devices descend from it. It has been recalled once.
- Decided
- Mar 5, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 0
242 later devices descend from it, 4 citing it directly. 1 of the 243 devices in this family, counting this one, has a Class I recall.
- This deviceK955731 Osteonics Shoulder Humeral ComponentsOsteonics Corp. · 1996
- Descendant · cites it directly · 235 of its ownK982981 New Zimmer Shoulder SystemZimmer, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 218 of its ownK041549 Zimmer Trabecular Metal Humeral StemZimmer, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 216 of its ownK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 207 of its ownK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
Showing 5 of 242 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations on · 2008
Most influential descendants
Showing 5 of 242 · See all- K982981New Zimmer Shoulder SystemZimmer, Inc. · 1998 · cites it directly235descendants
- K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc. · 2004 · 2 generations on218descendants
- K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · 3 generations on216descendants
- K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · 4 generations on207descendants
- K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · 4 generations on190descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955731 | Osteonics Shoulder Humeral Components | Osteonics Corp. | 1996 | — |
| +1 | K982981 | New Zimmer Shoulder System | Zimmer, Inc. | 1998 | 1 |
| +2 | K041549 | Zimmer Trabecular Metal Humeral Stem | Zimmer, Inc. | 2004 | 8 |
| +3 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| +4 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| +4 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 1 |
| 2010 | 5 | 0 |
| 2011 | 10 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 16 | 0 |
| 2018 | 12 | 0 |
| 2019 | 17 | 0 |
| 2020 | 20 | 0 |
| 2021 | 22 | 0 |
| 2022 | 18 | 0 |
| 2023 | 15 | 0 |
| 2024 | 14 | 0 |
| 2025 | 15 | 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 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? (4)
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 |
|---|---|---|---|
| * | — | Osteonics® Shoulder Humeral Components Named without a submission number | |
| * | — | Global Shoulder Named without a submission number | |
| * | — | Bio-Modular Total Shoulder Named without a submission number | |
| * | — | Monospherical Shoulder Prosthesis Named without a submission number |
What descends from it? (242)
See all 2424 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 |
|---|---|---|---|---|
| Nov 13, 2008 | Not classified | Z-0888-2009 | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. |
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 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K982981 (Zimmer, Inc., 1998) has gone furthest, with 235 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?
Aseptic necrosis of the humeral head.
Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Proximal humeral fracture and/or dislocation.
Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
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/K955731 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955731: Osteonics Shoulder Humeral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955731
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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