510(k) · Cleared
Recalled · Class II · 2019Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock 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 May 1, 2015 as substantially equivalent to K840954 (Synthes (Usa), 1984) and 2 other predicates after a 35-day review. Its family tree reaches back 1 generation to 1979. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- May 1, 2015
- Review
- 35 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 1 generation to K791619 (1979). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK791619 Dynamic Hip ScrewSynthes (Usa) · 1979
- This deviceK150818 Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation…Zimmer, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
- Descendant · 2 generations on · 0 of its ownK230764 OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791619 | Dynamic Hip Screw | Synthes (Usa) | 1979 | — |
| 0 (this device) | K150818 | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System… | Zimmer, Inc. | 2015 | — |
| +1 | K210247 | OsteoCentric Integrated Hip Fastener System | Osteocentric Technologies D.B.A. Osteocentric Trauma | 2021 | — |
| +2 | K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 21.3 · 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K840954 | Dynamic Condylar Screw or D.C.S.Summary page 6…§ 888.3030, KTT) Classification Panel: Orthopedics/87 Predicate Device(s): Dynamic Condylar Screw (DCS), manufactured by Synthes (K840954, cleared May 11, 1984). Versa-Fx Femoral Fixation System, manufactured by… | 1984 |
| * | K954555 | Versa-FX Femoral Fixation SystemSummary page 6…Synthes (K840954, cleared May 11, 1984). Versa-Fx Femoral Fixation System, manufactured by Zimmer (K954555, cleared January 26, 1996). Dynamic Hip Screw (DHS), manufactured by Synthes… | 1996 |
| * | K791619 | Dynamic Hip ScrewSummary page 6…Zimmer (K954555, cleared January 26, 1996). Dynamic Hip Screw (DHS), manufactured by Synthes (K791619, cleared August 28, 1979) 14 === Page… | 1979 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210247 | OsteoCentric Integrated Hip Fastener System | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0326-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| May 4, 2016 | Class II | Z-1682-2016 | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. |
| Jan 11, 2016 | Class II | Z-1129-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Jan 11, 2016 | Class II | Z-1139-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Jan 11, 2016 | Class II | Z-1118-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Jan 11, 2016 | Class II | Z-1163-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2015, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Versa-Fx Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures. Supracondylar: The Versa-Fx II Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the…
Read the full statement (151 words)
The Versa-Fx Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures.
Supracondylar: The Versa-Fx II Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures.
Proximal Femur: The Versa-Fx II Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).
The Free-Lock Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150818: Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150818
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026