# K032770: Endotine Forehead Device

- Pathway: 510(k) (Special)
- Applicant: Coapt Systems, Inc.
- Decided: Oct 8, 2003 after 30 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: 1 generation back to K014153 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014153: Coapt Systmes Endotine Device, Coapt Systems, Inc. (2002)

## Indications for use
The ENDOTINE ForeheadTMDevice is intended for use in subperiosteal browplasty surgery. The ENDOTINE ForeheadTM Device is specifically indicated for use to fixate the sub-dermis to the cranial bone in browplasty.

Source page: https://510kreport.com/device/K032770
Methodology: https://510kreport.com/methodology