510(k) · Cleared
ClearedFenlin II Shoulder Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Apr 3, 1987 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 237 devices in its family, counting itself, has a Class I recall. 236 later devices descend from it.
- Decided
- Apr 3, 1987
- Review
- 70 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 0
236 later devices descend from it, 1 citing it directly. 1 of the 237 devices in this family, counting this one, has a Class I recall.
- This deviceK870262 Fenlin II Shoulder ProsthesisZimmer, Inc. · 1987
- 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 236 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 236 · 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) | K870262 | Fenlin II Shoulder Prosthesis | Zimmer, Inc. | 1987 | — |
| +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 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 1 |
| 2010 | 5 | 0 |
| 2011 | 9 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 15 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (236)
See all 2361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982981 | New Zimmer Shoulder System | 1998 | 235 |
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 · 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 | — |
https://510kreport.com/device/K870262 · printed Nov 4, 2026
Cite this page
510(k) Report. “K870262: Fenlin II Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K870262
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026