# K060248: Ultratine Transbleph

- Pathway: 510(k) (Traditional)
- Applicant: Coapt Systems, Inc.
- Decided: Jun 12, 2006 after 132 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: 4 generations back to K014153 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040740: Endotine Transbleph Device, Coapt Systems, Inc. (2004) Summary page 2.
- K944110: Vicryl Rapide Suture, ETHICON, Inc. (1995) Summary page 2.

## Indications for use
The ULTRATINE TransBleph TM is intended for use in subperiosteal browplasty fixation. The ULTRATINE TransBleph is specifically indicated for use to fixate the subdermis to the frontal bone.

Source page: https://510kreport.com/device/K060248
Methodology: https://510kreport.com/methodology