# K050226: Asian Intramedullary Hip Screw Nails

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 11, 2005 after 10 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981529 (1998). 9 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040656: Modification to Smith & Nephew Intramedullary Hip Screw, Smith & Nephew, Inc. (2004) Summary page 1.
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System, Smith & Nephew, Inc. (1999) Summary page 1.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 1.
- K952697: Titanium Classic Compression Hip Screw System, Smith & Nephew Richards, Inc. (1995) Summary page 1.

## Most influential descendants
- K092748: Sureshot Tan Nails and Accessories (2010), 4 descendants of its own
- K243364: TRIGEN META-TAN Trochanteric Antegrade Nail (2024), 1 descendant of its own
- K181640: X-BOLT Hip Fracture Fixation System (2018), 1 descendant of its own
- K243608: TRIGEN Stable Lock Nut & Washer (2025), 0 descendants of its own
- K221621: Pro-X1™ Trochanteric Nailing System (2023), 0 descendants of its own

## Indications for use
Intramedullary Hip Screws are indicated for intracapsular fractures of the femoral neck; trochanteric or subtrochanteric fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures using a supracondylar plate; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Asian Intramedullary Hip Screws and accessories are for single use only.

Source page: https://510kreport.com/device/K050226
Methodology: https://510kreport.com/methodology