# K061507: Sonicweld RX Endobrow Fixation

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Sep 21, 2006 after 112 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904436 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051236: Resorb-X SF, KLS-Martin L.P. (2005)
- K051845: The Bioplate Resorbable Endobrow Fixation System, Bioplate, Inc. (2005) Summary page 1.
- K013557: Lactosorb Craniofacial Anchor-Push Screw, Walter Lorenz Surgical, Inc. (2001)

## Indications for use
The SonicWeld Rx Endobrow Fixation will be used to support non-load bearing tissues of the craniofacial skeleton, including but not limited to endobrow fixation.

Source page: https://510kreport.com/device/K061507
Methodology: https://510kreport.com/methodology