510(k) · Cleared
Recalled · Class II · 2013Versa-FX Femoral Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 26, 1996 after a 116-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 76 later devices descend from it. It has been recalled once.
- Decided
- Jan 26, 1996
- Review
- 116 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 0
76 later devices descend from it, 3 citing it directly.
- This deviceK954555 Versa-FX Femoral Fixation SystemZimmer, Inc. · 1996
- Descendant · cites it directly · 71 of its ownK983814 Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical · 1999
- Descendant · 2 generations on · 35 of its ownK080434 Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008
- Descendant · 3 generations on · 34 of its ownK090656 Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 4 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K983814Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical · 1999 · cites it directly71descendants
- K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008 · 2 generations on35descendants
- K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009 · 3 generations on34descendants
- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 3 generations on33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954555 | Versa-FX Femoral Fixation System | Zimmer, Inc. | 1996 | — |
| +1 | K983814 | Gotfried Percutaneous Compression Plating System | Efratgo, Ltd. HI Tech Bio-Surgical | 1999 | — |
| +2 | K080434 | Intertan CHS Locking Plate System Prox Fem Plates/Screw | Smith & Nephew, Inc. | 2008 | — |
| +3 | K090656 | Intertan CHS Limited Collapse Set Screw | Smith & Nephew, Inc. | 2009 | — |
| +3 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +4 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.4 · 14 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? (76)
See all 763 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2013 | Class II | Z-1005-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K983814 (Efratgo, Ltd. HI Tech Bio-Surgical, 1999) has gone furthest, with 71 descendants of its own.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
https://510kreport.com/device/K954555 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954555: Versa-FX Femoral Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954555
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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