# K041835: Endotine Midface B 4.5 Device

- Pathway: 510(k) (Traditional)
- Applicant: Coapt Systems, Inc.
- Decided: Sep 28, 2004 after 83 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: 3 generations back to K014153 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032698: Coapt Endotine Midface-ST 4.5 Device, Coapt Systems, Inc. (2003) Summary page 2.
- K974309: Lactosorb Panels, Biomet, Inc. (1998) Summary page 2.

## Indications for use
The ENDOTINE Midface B 4.5 is intended for use in subperiosteal midface suspension surgery. Specifically, the ENDOTINE Midface B 4.5 is indicated for use in suspending the subcutaneous tissues of the midface from the infra-orbital rim or zygoma via an anchoring leash.

Source page: https://510kreport.com/device/K041835
Methodology: https://510kreport.com/methodology