# K964362: Kinamed Profix System

- Pathway: 510(k) (Traditional)
- Applicant: Kinamed, Inc.
- Decided: Jan 16, 1997 after 76 days
- Product code: HRS (Plate, 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.
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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K122049: Neuropro Low Profile Cranial Plating System (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K964362
Methodology: https://510kreport.com/methodology