# K253155: Fule Metallic Lockable Intramedullary Nail Systems

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Fule Science & Technology Development Co., Ltd.
- Decided: Jun 17, 2026 after 264 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: 7 generations back to K951740 (1995). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200880: T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System, Stryker GmbH (2020) Summary page 6.
- K182783: DePuy Synthes Trauma Orthopedic Nail Implants, DePuy Synthes (2018) Summary page 6.

## Indications for use
The Intramedullary Nail System of The Fule Metallic Lockable Intramedullary Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an open or closed technique and can be statically, dynamically and compressed locked. It is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: * Open and closed tibial fractures * Pseudoarthrosis and correction osteotomy » Pathologic fractures, impending pathologic fractures, and tumor resections * Nonunion and malunion. The Fule Proximal Femoral Nail Systems (PFNA System and SISF System) of the Fule Metallic Lockable Intramedullary Nail are intended for the treatment of stable and unstable fractures of the proximal femur, including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. * Short nails (PFNA:170-240 mm / SISF: 180—240 mm): * Pertrochanteric fractures * Intertrochanteric fractures » Basal neck fractures » Combinations of these fracture types * Long nails (PFNA:300—420 mm): » Subtrochanteric fractures * Pertrochanteric fractures associated with shaft fractures » Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions * Long subtrochanteric fractures * Proximal or distal non-unions * Malunions * Revisions

Source page: https://510kreport.com/device/K253155
Methodology: https://510kreport.com/methodology