# K960782: Titanium Tube to Tube Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 8, 1996 after 72 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Ace Medical’s Articulation Coupler: named in the summary without a submission number

## Indications for use
Synthes Ti Tube to Tube Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the two carbon fiber rods or stainless steel tubes.

Source page: https://510kreport.com/device/K960782
Methodology: https://510kreport.com/methodology