# K991029: Rapidflap Cranial Clamp

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Apr 23, 1999 after 25 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
Longest line of descent: 1 generation back to K971252 (1998). 1 ancestor in all.
72 later devices descend from it; 6 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)
- K971252: Sevrain Cranial Clamp, Ikonos Corp. (1998) Summary page 1.

## Most influential descendants
- 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
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own

## Indications for use
RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.

Source page: https://510kreport.com/device/K991029
Methodology: https://510kreport.com/methodology