# K971408: Sevrain Cranial Clamp (SCC-200 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Ikonos Corp.
- Decided: May 12, 1998 after 391 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K013050: The Bioplate Zip Craniotomy Fixation System (2001), 4 descendants of its own
- K020088: Modification of the Bioplate Zip Craniotomy Fixation System (2002), 2 descendants of its own
- K070901: Modified Plate  Design for Bioplate Zip Craniotomy Fixation System (2007), 1 descendant of its own
- K082175: Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation (2008), 0 descendants of its own
- K051293: Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation System (2005), 0 descendants of its own

## Indications for use
The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.

Source page: https://510kreport.com/device/K971408
Methodology: https://510kreport.com/methodology