# K123948: China Nails and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 14, 2013 after 83 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981529 (1998). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 1.
- K092748: Sureshot Tan Nails and Accessories, Smith & Nephew, Inc. (2010) Summary page 1.
- K111025: Trigen Low Profile Bone Screw, Smith & Nephew, Inc. (2011) Summary page 1.

## Indications for use
The China Nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. China Nail is for single use only.

Source page: https://510kreport.com/device/K123948
Methodology: https://510kreport.com/methodology