# K962484: Synthes Titanium External Fixator Clamps (TI Efc)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 5, 1996 after 71 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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.
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) Synthes Hybrid External Fixator clamps: named in the summary without a submission number
- (no number) Synthes Titanium Universal Clamp: named in the summary without a submission number
- (no number) Synthes Ti Tube to Tube Clamp: named in the summary without a submission number
- (no number) Ti-6Al-4V External Fixator Clamps: named in the summary without a submission number

## Indications for use
Synthes Ti External Fixator Clamps are used in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation.

Source page: https://510kreport.com/device/K962484
Methodology: https://510kreport.com/methodology