# K961027: Orthofix Tibial Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: May 8, 1996 after 55 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 K912420 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912420: Orthofix Unreamed Tibial Nail System, Scientific Research (1991) Summary page 3.
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 3.
- (no number) Richards’ Russell Taylor System: named in the summary without a submission number

## Most influential descendants
- K973944: Orthofix Femoral Nailing Sytem (1997), 0 descendants of its own

## Indications for use
The system is indicated for fixation of tie following conditions where the area requiring fixation is distal to the tibial tuberosity and at least 55 mm proximal to the distal articular surface: acute traumatic fractures; pathological fractures; delayed or non-unions; stabilization after corrective osteotomy; and bone transport.

Source page: https://510kreport.com/device/K961027
Methodology: https://510kreport.com/methodology