# K970733: Synthes Titanium Diastal Femoral Nail (TI DFN) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 2, 1997 after 33 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
59 later devices descend from it; 3 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Richard’s IMSC Five Nail: named in the summary without a submission number
- (no number) Ace’s Retrograde Trauma Nail: named in the summary without a submission number

## Most influential descendants
- K013449: Modification to Fixion Interlocking Intramedullary Nailing System (2001), 54 descendants of its own
- K023437: Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail (2002), 53 descendants of its own
- K032588: Modification to Fixion Intramedullary Nailing System (Fixion IM) (2003), 32 descendants of its own
- K031401: Fixion Dynamic Hip Screw System (Fixion DHS) (2003), 32 descendants of its own
- K091425: Quantum M Composite Nailing System (2010), 31 descendants of its own

## Recalls of this device
- Apr 18, 2013 · Class II · Z-2243-2013: Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.

## Indications for use
The Synthes Ti DFN System is generally intended to stabilize fractures of the distal femur. Specifically, the Ti DFN is intended for supracondylar fractures (including those with intra-articular and/or extra-articular involvement), pathologic fractures, mal-unions, non-unions, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee, fractures distal to a total hip, fractures in the multiply injured patient, fractures in the morbidly obese patient, and fractures in osteoporotic bone. The Ti DFN can be used in either reamed or non-reamed applications.

Source page: https://510kreport.com/device/K970733
Methodology: https://510kreport.com/methodology