# K111667: Synthes Suprapatellar Insertion Instruments

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Dec 5, 2011 after 174 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951740 (1995). 11 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 30 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 1.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 1.

## Most influential descendants
- K131365: T2 Tibial Nailing System (2013), 17 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
- K203819: T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System (2021), 7 descendants of its own
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own

## Recalls of this device
- Oct 14, 2013 · Class II · Z-0404-2014: Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.

## Indications for use
The Synthes Suprapatellar Insertion Instruments are part of the Synthes Tibial Nail System EX. The 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/K111667
Methodology: https://510kreport.com/methodology