# K014153: Coapt Systmes Endotine Device

- Pathway: 510(k) (Traditional)
- Applicant: Coapt Systems, Inc.
- Decided: Mar 15, 2002 after 87 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
No predicates in its family tree.
83 later devices descend from it; 8 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bionx Endobrow Screw: named in the summary without a submission number

## Most influential descendants
- K023922: Coapt Systems Endotine Device, Model CFD-101-00197 (2002), 81 descendants of its own
- K032698: Coapt Endotine Midface-ST 4.5 Device (2003), 74 descendants of its own
- K041593: Featherlift Extended Length Aptos Thread (2004), 72 descendants of its own
- K050548: Contour Midface Opposing Uni-Directional Threads (2005), 65 descendants of its own
- K051609: Quill Synthetic Absorbable Barbed Suture (2005), 64 descendants of its own

## Indications for use
The Endotine Device is intended for use in browplasty surgery. The Endotine device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.

Source page: https://510kreport.com/device/K014153
Methodology: https://510kreport.com/methodology