510(k) · Cleared
ClearedFinn Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Feb 14, 1996 after a 489-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 75 later devices descend from it.
- Decided
- Feb 14, 1996
- Review
- 489 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 0
75 later devices descend from it, 5 citing it directly.
- This deviceK945028 Finn Knee SystemBiomet, Inc. · 1996
- Descendant · cites it directly · 54 of its ownK013385 Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 13 of its ownK070978 Zimmer Segmental SystemZimmer, Inc. · 2007 · Recalled
- Descendant · cites it directly · 13 of its ownK031804 Compress Distal Femoral ReplacementBiomet, Inc. · 2003
- Descendant · cites it directly · 12 of its ownK041352 Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
- Descendant · 2 generations on · 11 of its ownK143179 The LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG · 2015 · Recalled
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K013385Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002 · cites it directly54descendants
- K070978Zimmer Segmental SystemZimmer, Inc. · 2007 · 2 generations on13descendants
- K031804Compress Distal Femoral ReplacementBiomet, Inc. · 2003 · cites it directly13descendants
- K041352Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004 · cites it directly12descendants
- K143179The LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG · 2015 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| +1 | K013385 | Nexgen Complete Knee Solution Rotatng Hinge Knee | Zimmer, Inc. | 2002 | 2 |
| +2 | K070978 | Zimmer Segmental System | Zimmer, Inc. | 2007 | 6 |
| +1 | K031804 | Compress Distal Femoral Replacement | Biomet, Inc. | 2003 | — |
| +1 | K041352 | Compress Distal Femoral Replacement System | Biomet, Inc. | 2004 | — |
| +2 | K143179 | The LINK® Endo-Model® Knee System | Waldemar Link GmbH & Co. KG | 2015 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 10 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 9 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 KRO? 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 KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 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? (75)
See all 755 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, K013385 (Zimmer, Inc., 2002) has gone furthest, with 54 descendants of its own.
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, 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 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
https://510kreport.com/device/K945028 · printed Nov 5, 2026
Cite this page
510(k) Report. “K945028: Finn Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945028
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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