# K973944: Orthofix Femoral Nailing Sytem

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Dec 19, 1997 after 64 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912420 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961027: Orthofix Tibial Nailing System, Orthofix, Inc. (1996) Summary page 2.
- K860756: Grosse and Kempf Locking Nail System, Non-Slot Rod, Howmedica Corp. (1986) Summary page 3.
- (no number) Smith & Nephew Richards Femoral Interlocking Nail System: named in the summary without a submission number

## Indications for use
The Orthofix Femoral Nailing System is indicated for the following: traumatic fractures; pathological fractures; refractures; non-unions;, reconstructive surgery; and bone transport.

Source page: https://510kreport.com/device/K973944
Methodology: https://510kreport.com/methodology