# K962047: Titanium Cannulated Tibial Nail (TI CTN)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 24, 1996 after 57 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
No predicates in its family tree.
36 later devices descend from it; 7 cite it directly.
0 of 37 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 Ti-6Al-7Nb Unreamed Tibial Nail: named in the summary without a submission number
- (no number) Synthes Titanium Tibial Nail System: named in the summary without a submission number

## Most influential descendants
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System (2013), 14 descendants of its own
- K080706: Connexx Locking Tibia Nail (2008), 11 descendants of its own
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own

## Indications for use
Both devices mentioned above are intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions.

Source page: https://510kreport.com/device/K962047
Methodology: https://510kreport.com/methodology