# K032698: Coapt Endotine Midface-ST 4.5 Device

- Pathway: 510(k) (Traditional)
- Applicant: Coapt Systems, Inc.
- Decided: Oct 23, 2003 after 51 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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.
74 later devices descend from it; 2 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023922: Coapt Systems Endotine Device, Model CFD-101-00197, Coapt Systems, Inc. (2002). Our OCR of the scanned summary read 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”.
- K014153: Coapt Systmes Endotine Device, Coapt Systems, Inc. (2002) Summary page 2.
- K974309: Lactosorb Panels, Biomet, Inc. (1998) Summary page 2.
- (no number) PDS II Suture: named in the summary without a submission number

## Most influential descendants
- 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
- K071989: Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material (2007), 31 descendants of its own
- K080680: Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone (2008), 30 descendants of its own

## Indications for use
The ENDOTINE Midface™-ST 4.5 is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

Source page: https://510kreport.com/device/K032698
Methodology: https://510kreport.com/methodology