# K080706: Connexx Locking Tibia Nail

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
- Decided: Jun 9, 2008 after 89 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: 3 generations back to K914453 (1992). 16 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 28 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.
- K032097: Depuy Ace Versanail Tibial Nail, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K962047: Titanium Cannulated Tibial Nail (TI CTN), Synthes (Usa) (1996) Summary page 1.
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 1.
- K002325: Wujin #3 Tibial Nail, Biologically Oriented Prostheses (2000) Summary page 1.
- K043270: Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series, Zimmer GmbH (2005) Summary page 1.
- K915435: Interlocking Tibial Nailing System, Stryker Corp. (1992) Summary page 1.

## Most influential descendants
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K161327: Syntec Humeral Nail System (2017), 3 descendants of its own
- K181296: Syntec Femoral Nail System (2019), 2 descendants of its own
- K141228: Aos 6.5MM Captured, Fully Threaded Cancellous Screw (2014), 2 descendants of its own
- K230257: Arthrex Intramedullary Nails (2023), 1 descendant of its own

## Indications for use
Indications for use include open and closed tibial shaft fractures" certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrothis of the tibial shaft, mataphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone transport, and fractures with bone loss.

Source page: https://510kreport.com/device/K080706
Methodology: https://510kreport.com/methodology