# K072127: Dominator

- Pathway: 510(k) (Special)
- Applicant: Biocomposites, Ltd.
- Decided: Aug 31, 2007 after 29 days
- Product code: HWC (Screw, Fixation, Bone)
- 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 no predicate by number.

## Indications for use
DominatorTM is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.

Source page: https://510kreport.com/device/K072127
Methodology: https://510kreport.com/methodology