# K201336: DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Sep 3, 2020 after 106 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000089 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040762: Synthes (Usa) Tibial Nail System EX, Synthes (Usa) (2004) Summary page 4.
- K000089: Synthes 4.0 and 5.0 MM Locking Screws, Synthes (Usa) (2000) Summary page 4.

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0228-2026: Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packag
- Sep 26, 2025 · Class II · Z-0229-2026: Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packag

## Indications for use
DePuy Synthes Tibial Nail Advanced System: The Tibial Nail Advanced implants are intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the implants are indicated for: • Open and closed proximal and distal tibial fractures • Open and closed tibial shaft fractures • Tibial malunions and nonunions DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm: DePuy Synthes Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails.

Source page: https://510kreport.com/device/K201336
Methodology: https://510kreport.com/methodology