# K172545: SERI Contour

- Pathway: 510(k) (Special)
- Applicant: Sofregen Medical, Inc.
- Decided: Sep 22, 2017 after 30 days
- Product code: OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K921895 (1992). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123128: Seri Surgical Scaffold, Allergan (2013) Summary page 4.

## Indications for use
SERI® Contour is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery and general soft tissue reconstruction.

Source page: https://510kreport.com/device/K172545
Methodology: https://510kreport.com/methodology