# K974206: Synthes Cranial Spring Clip (CSC)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 16, 1998 after 126 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953806 (1996). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953806: Synthes (Usa) Midfacial System, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- K100205: Frontier Devices Neuro System (2010), 5 descendants of its own
- K141911: Optimus Neuro System (2015), 4 descendants of its own
- K183352: Optimus Neuro System (2019), 2 descendants of its own
- K190811: Optimus NEURO System - Sterile Kit (2019), 1 descendant of its own
- K212391: MCI-Neuro Fixation System (2022), 0 descendants of its own

## Indications for use
Synthes CSC is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure. The CSC is contraindicated in the following situations: in patients with a skull thickness less than 4 mm; or when the gap surrounding the bone flap is greater than 2 mm. The CSC is MRI Compatible.

Source page: https://510kreport.com/device/K974206
Methodology: https://510kreport.com/methodology