# K033524: Coapt Endotine Chin 3.5 Device

- Pathway: 510(k) (Traditional)
- Applicant: Coapt Systems, Inc.
- Decided: Dec 18, 2003 after 41 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). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 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). Our reading of the summary gave K023992, FDA’s number for Wiener Lab Colinesterasa AA (Wiener Laboratories Saic). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ENDOTINE Forehead Device”.
- K974309: Lactosorb Panels, Biomet, Inc. (1998) Summary page 2.

## Most influential descendants
- K040740: Endotine Transbleph Device (2004), 2 descendants of its own
- K060248: Ultratine Transbleph (2006), 0 descendants of its own
- K042796: Endotine Transbleph 3.0/3.5 Device (2004), 0 descendants of its own

## Indications for use
The ENDOTINE Chin TM 3.5 is intended for use in subperiosteal chinplasty surgery. The ENDOTINE ChinTM 3.5 is specifically indicated for use to fixate the subdermis to the mentum in chinplasty.

Source page: https://510kreport.com/device/K033524
Methodology: https://510kreport.com/methodology