510(k) · Cleared
ClearedFenlin Total Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Feb 12, 1986 after a 272-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
- Feb 12, 1986
- Review
- 272 days
- 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 deviceK852137 Fenlin Total ShoulderZimmer, Inc. · 1986
- 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) | K852137 | Fenlin Total Shoulder | Zimmer, Inc. | 1986 | — |
| +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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
https://510kreport.com/device/K852137 · printed Nov 5, 2026
Cite this page
510(k) Report. “K852137: Fenlin Total Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K852137
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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