# K031034: Spin Down Rapidflap

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: May 21, 2003 after 50 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971252 (1998). 2 ancestors in all.
63 later devices descend from it; 1 cites it directly.
0 of 66 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.
- K991029: Rapidflap Cranial Clamp, Walter Lorenz Surgical, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K202889: Able Medical Devices Valkyrie Thoracic Fixation System (2021), 39 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own

## Recalls of this device
- Aug 22, 2018 · Class II · Z-0393-2019: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- Aug 22, 2018 · Class II · Z-0394-2019: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- Aug 22, 2018 · Class II · Z-0395-2019: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- Aug 22, 2018 · Class II · Z-0398-2019: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- Aug 22, 2018 · Class II · Z-0396-2019: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- Aug 22, 2018 · Class II · Z-0397-2019: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.

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

Source page: https://510kreport.com/device/K031034
Methodology: https://510kreport.com/methodology