# K971252: Sevrain Cranial Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Ikonos Corp.
- Decided: Jul 6, 1998 after 459 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
73 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K991029: Rapidflap Cranial Clamp (1999), 72 descendants of its own
- K031034: Spin Down Rapidflap (2003), 63 descendants of its own
- K022277: Osteomed Cranial Flap Fixation System (2003), 63 descendants of its own
- K062857: KLS Martin Quick Disc (2006), 62 descendants of its own
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile (2007), 61 descendants of its own

## Indications for use
The SCC-100 1s indicated for the re-attachment of the bone flap after a craniotomy.

Source page: https://510kreport.com/device/K971252
Methodology: https://510kreport.com/methodology