# K170972: Apex Tibial Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Orthoxel
- Decided: Dec 20, 2017 after 261 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: 6 generations back to K000684 (2000). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063570: Biomet Tibial Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 4.
- K082770: Zimmer Natural Nail System Tibial Nail, Zimmer, Inc. (2008) Summary page 4.
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail, I.T.S. GmbH (2014) Summary page 4.

## Most influential descendants
- K252025: Active Intramedullary (AIM) Tibial Nail System (2026), 0 descendants of its own

## Indications for use
The Apex Tibial Nailing system is intended for temporary fixation and stabilization of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of: * Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures; * Fractures involving osteopenic or osteoporotic bone; * Fractures with bone loss; * Pseudoarthosis, nonunion, and malunion; * Correction osteotomy; * Pathologic fractures and prophylactic nailing of impending pathologic fractures; and * Reconstruction following tumour resection.

Source page: https://510kreport.com/device/K170972
Methodology: https://510kreport.com/methodology