# K961360: True/Fit Femoral Intramedullary Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Mar 13, 1997 after 338 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: 1 generation back to K813371 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813371: Grosse and Kempf Locking Nail Sys., Howmedica Corp. (1982) Summary page 2.
- K893377: Russell-Taylor Intramedullary Knee Fusion Nails, Richards Medical Co., Inc. (1989) Summary page 2.
- K914371: Universal Femoral Nail, Synthes (Usa) (1992) Summary page 2.

## Indications for use
TRUE/FIT™ Femoral Intramedullary Rod System is intended as an implantable device for the fixation of the following types of femoral fractures: femoral shaft fractures high and low subtrochanteric fractures of the femur (femoral shaft fractures distal to the proximal portion of the lesser trocahanter) intertrochanteric femoral fractures femoral neck fractures ipsilateral femoral neck and shaft fractures

Source page: https://510kreport.com/device/K961360
Methodology: https://510kreport.com/methodology