# K042078: Endotine Forehead Triple Device

- Pathway: 510(k) (Special)
- Applicant: Coapt Systems, Inc.
- Decided: Aug 27, 2004 after 25 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: 2 generations back to K014153 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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) Summary page 2.
- K023922: Coapt Systems Endotine Device, Model CFD-101-00197, Coapt Systems, Inc. (2002) Summary page 2.

## Indications for use
The ENDOTINE ForeheadTM Triple is intended for use in subperiosteal browplasty surgery. The ENDOTINE ForeheadTM Triple Device is specifically indicated for use to fixate the subcutaneous tissues to the cranial bone in browplasty.

Source page: https://510kreport.com/device/K042078
Methodology: https://510kreport.com/methodology