510(k) · Cleared
ClearedOsteonics All Polyethylene Glenoid Shoulder Component
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 Jun 16, 1995 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 45 later devices descend from it.
- Decided
- Jun 16, 1995
- Review
- 130 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 2 citing it directly.
- This deviceK950521 Osteonics All Polyethylene Glenoid Shoulder ComponentOsteonics Corp. · 1995
- Descendant · cites it directly · 43 of its ownK103835 Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model…Howmedica Osteonics Corp. · 2011 · Recalled
- Descendant · 2 generations on · 31 of its ownK130759 Humelock II Cementless Shoulder SystemFx Solutions · 2013
- Descendant · 3 generations on · 30 of its ownK150488 Humelock II Reversible Shoulder SystemFx Solutions · 2015
- Descendant · 4 generations on · 20 of its ownK163669 Humeris ShoulderFx Solutions · 2017
- Descendant · 4 generations on · 17 of its ownK162455 Humelock Reversed ShoulderFx Solutions · 2017
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp. · 2011 · cites it directly43descendants
- K130759Humelock II Cementless Shoulder SystemFx Solutions · 2013 · 2 generations on31descendants
- K150488Humelock II Reversible Shoulder SystemFx Solutions · 2015 · 3 generations on30descendants
- K163669Humeris ShoulderFx Solutions · 2017 · 4 generations on20descendants
- K162455Humelock Reversed ShoulderFx Solutions · 2017 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950521 | Osteonics All Polyethylene Glenoid Shoulder Component | Osteonics Corp. | 1995 | — |
| +1 | K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX… | Howmedica Osteonics Corp. | 2011 | 1 |
| +2 | K130759 | Humelock II Cementless Shoulder System | Fx Solutions | 2013 | — |
| +3 | K150488 | Humelock II Reversible Shoulder System | Fx Solutions | 2015 | — |
| +4 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | — |
| +4 | K162455 | Humelock Reversed Shoulder | Fx Solutions | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWS? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (45)
See all 452 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K103835 (Howmedica Osteonics Corp., 2011) has gone furthest, with 43 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 | — |
https://510kreport.com/device/K950521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950521: Osteonics All Polyethylene Glenoid Shoulder Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950521
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026