# K031401: Fixion Dynamic Hip Screw System (Fixion DHS)

- Pathway: 510(k) (Traditional)
- Applicant: Disco-O-Tech Medical Technologies, Ltd.
- Decided: Aug 6, 2003 after 93 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K970097 (1997). 30 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010988: Fixion Interlocking Proximal Femoral Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001)
- K012967: Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System, Disco-O-Tech Medical Technologies, Ltd. (2001)
- K023437: Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail, Disco-O-Tech Medical Technologies, Ltd. (2002) Summary page 2.
- K983814: Gotfried Percutaneous Compression Plating System, Efratgo, Ltd. HI Tech Bio-Surgical (1999) Summary page 2.
- K964880: Vari-Angle Hip Screw (VHS) System, Walter Abendschein, M.D. (1997) Summary page 2.
- K972629: Depuy AE TK2 Hip Screw System, Depuy, Inc. (1997) Summary page 2.
- K002783: Fixion Interlocking Nail (Fixion IL Nail), Disco-O-Tech Medical Technologies, Ltd. (2000). 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”. Summary page 3.
- K013449: Modification to Fixion Interlocking Intramedullary Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001)

## Most influential descendants
- K091425: Quantum M Composite Nailing System (2010), 31 descendants of its own
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own
- K102597: Piccolo Composite Plate System (2011), 15 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K031401
Methodology: https://510kreport.com/methodology