# K973017: Synthes Combination Clamp and Dynamization Clip

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 16, 1997 after 64 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 Adjustable Clamp: named in the summary without a submission number

## Most influential descendants
- K122208: External Fixator System (2012), 0 descendants of its own

## Indications for use
The Synthes Combination Clamp with Dynamization Clip is generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for: stabilization of soft tissue injuries and open or closed fractures; polytrauma; vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures; arthrodesis and osteotomies with soft tissue problems; failures of total joints; neutralization of fractures stabilized with limited internal fixation; non-unions/septic non-unions; intraoperative reduction/stabilization tool to assist with indirect reduction; unilateral rectilinear bone segment transport or leg lengthening;

Source page: https://510kreport.com/device/K973017
Methodology: https://510kreport.com/methodology