510(k) · Cleared
ClearedFixion Dynamic Hip Screw System (Fixion DHS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disco-O-Tech Medical Technologies, Ltd. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Aug 6, 2003 as substantially equivalent to K010988 (Disc-O-Tech Medical Technologies, Ltd., 2001) and 7 other predicates after a 93-day review. Its family tree reaches back 5 generations to 1997. 32 later devices descend from it.
- Decided
- Aug 6, 2003
- Review
- 93 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K970097 (1997). 30 ancestors in all, the oldest K791619 (1979). 32 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 4 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 3 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 2 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
- 1 generation backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- This deviceK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003
- Descendant · cites it directly · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- Descendant · 2 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- Descendant · 2 generations on · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- Descendant · 2 generations on · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
- Descendant · cites it directly · 15 of its ownK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · cites it directly31descendants
- K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 2 generations on29descendants
- K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · 2 generations on16descendants
- K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · 2 generations on15descendants
- K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −4 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −3 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −2 | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | 2002 | 1 |
| −1 | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| 0 (this device) | K031401 | Fixion Dynamic Hip Screw System (Fixion DHS) | Disco-O-Tech Medical Technologies, Ltd. | 2003 | — |
| +1 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +2 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +2 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| +2 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
| +1 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | K010988 | Fixion Interlocking Proximal Femoral Nailing System | 2001 |
| * | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System | 2001 |
| * | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Summary page 2…w1 ,213 r--ixion Uynamic Hip Screw System 510(k) “redic ate Devices P Fixion Interlocking Proximal Femoral Intramedullary Nailing System (KO 10988, K O 12967, K023437) by Disc-0-Tech Medical Technologies, Ltd. P Gotfried PC.C.P (K983814)by Efiatgo. P Vari-Angle Hip Screw System - VHS (K9… | 2002 |
| * | K983814 | Gotfried Percutaneous Compression Plating SystemSummary page 2…Fixion Interlocking Proximal Femoral Intramedullary Nailing System (KO 10988, K O 12967, K023437) by Disc-0-Tech Medical Technologies, Ltd. P Gotfried PC.C.P (K983814)by Efiatgo. P Vari-Angle Hip Screw System - VHS (K964880)by Biomet. P TKZTMCompression Hip Screw System (K972629) by DePu… | 1999 |
| * | K964880 | Vari-Angle Hip Screw (VHS) SystemSummary page 2…System (KO 10988, K O 12967, K023437) by Disc-0-Tech Medical Technologies, Ltd. P Gotfried PC.C.P (K983814)by Efiatgo. P Vari-Angle Hip Screw System - VHS (K964880)by Biomet. P TKZTMCompression Hip Screw System (K972629) by DePuy ACE P Fixion Interlocking Intramedullary Nailing System… | 1997 |
| * | K972629 | Depuy AE TK2 Hip Screw SystemSummary page 2…edical Technologies, Ltd. P Gotfried PC.C.P (K983814)by Efiatgo. P Vari-Angle Hip Screw System - VHS (K964880)by Biomet. P TKZTMCompression Hip Screw System (K972629) by DePuy ACE P Fixion Interlocking Intramedullary Nailing System (K002873, KO1 3449,’ K023437) by Disc-0-Tech Medical… | 1997 |
| * | K002783 | Fixion Interlocking Nail (Fixion IL Nail) Our reading of the summary gave K002873, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Fixion Interlocking Intramedullary Nailing System”. | 2000 |
| * | K013449 | Modification to Fixion Interlocking Intramedullary Nailing System | 2001 |
What descends from it? (32)
See all 322 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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 7 of the 30 ancestors have a recall of any class.
- Of its descendants, K091425 (N.M.B. Medical Applications, Ltd., 2010) has gone furthest, with 31 descendants of its own.
- 11 other devices also cite its predicate K010988.
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 | — |
What is it indicated for?
The Fixion Dynamic Hip Screw System (“Fixion DHS”) is intended for use in fixation of
fractures in the proximal femur. The Fixion DHS is indicated for use in pertrochanteric,
intertrochanteric, and base of femur neck fractures.
The Fixion DHS can be implanted in either open or minimal invasive surgical approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031401: Fixion Dynamic Hip Screw System (Fixion DHS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031401
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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