# K040762: Synthes (Usa) Tibial Nail System EX

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 12, 2004 after 18 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
No predicates in its family tree.
48 later devices descend from it; 11 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Titanium Solid and Cannulated Tibial Nail: named in the summary without a submission number

## Most influential descendants
- K111667: Synthes Suprapatellar Insertion Instruments (2011), 18 descendants of its own
- K131365: T2 Tibial Nailing System (2013), 17 descendants of its own
- K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 16 descendants of its own
- K191271: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (2019), 15 descendants of its own
- 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 (2020), 11 descendants of its own

## Recalls of this device
- Jun 3, 2015 · Class II · Z-2051-2015: A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
- Nov 2, 2012 · Class II · Z-2058-2013: Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external 

## Indications for use
Synthes Tibial Nail System EX 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.

Source page: https://510kreport.com/device/K040762
Methodology: https://510kreport.com/methodology