# K130627: Swing-Off Screw

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Interventional Technology, LLC
- Decided: Aug 21, 2013 after 166 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961522 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050819: Charlotte Snap-Off Screw, Wrightmedicaltechnologyinc (2005) Summary page 2.
- K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple, Z-Medical GmbH & Co. KG (2012) Summary page 2.

## Indications for use
The BRM SWING-OFF SCREW is indicated for surgical fixation of bone fractures, osteotomies and bone reconstruction in order to position and maintain bony fragments in a desired orientation and to provide stable fixation of the osreotomy site until a stable bony union occurs. Examples include but are not limited to: -Fixation of small bone fragments -Weil osteotomy -Mono-cortical fixation -Osteotornies & fixation in foot and hand

Source page: https://510kreport.com/device/K130627
Methodology: https://510kreport.com/methodology