# K230071: Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Tdm Co., Ltd.
- Decided: Aug 22, 2024 after 590 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 K970097 (1997). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192003: Auxein Nailing System, Auxein Medical Private Limited (2020) Summary page 4.

## Indications for use
(1) Femur Reconstruction Interlocking Nail System The Femur Reconstruction Interlocking Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. (2) Femur Retrograde Interlocking Nail System The Femur Retrograde Interlocking Nail System is indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated. (3) Humerus Interlocking Nail System The Humerus Interlocking Nail System indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures. (4) Tibia Interlocking Nail System The Tibia Interlocking Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions. (5) Compression Hip Nail System The Compression Hip Nail System is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.

Source page: https://510kreport.com/device/K230071
Methodology: https://510kreport.com/methodology