# K123128: Seri Surgical Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Allergan
- Decided: Apr 25, 2013 after 203 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: 10 generations back to K921895 (1992). 47 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080442: Seriscaffold Surgical Mesh, Serica Technologies, Inc. (2008) Summary page 1.
- K083898: Surgimend, Tei Biosciences, Inc. (2009) Summary page 1.
- K810428: Vicryl, ETHICON, Inc. (1981) Summary page 1.

## Most influential descendants
- K140533: Galaflex Mesh (2014), 3 descendants of its own
- K161092: GalaSHAPE 3D (2016), 1 descendant of its own
- K202425: SurgiLattice scaffold (2021), 0 descendants of its own
- K172545: SERI Contour (2017), 0 descendants of its own
- K162922: GalaFORM 3D (2017), 0 descendants of its own

## Indications for use
SERI Surgical Scaffold 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/K123128
Methodology: https://510kreport.com/methodology