# K080442: Seriscaffold Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Serica Technologies, Inc.
- Decided: Nov 13, 2008 after 268 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921895 (1992). 14 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810428: Vicryl, ETHICON, Inc. (1981) Summary page 1.
- K043366: Permacol Surgical Implant, Tissue Science Laboratories, Plc (2004) Summary page 1.
- (no number) Bard Mesh®: named in the summary without a submission number
- (no number) Mersilene™ Mesh: named in the summary without a submission number

## Most influential descendants
- K090288: Orthadapt PR (2009), 7 descendants of its own
- K123128: Seri Surgical Scaffold (2013), 5 descendants of its own
- K112786: Proseries Bioimplants-Proankle/Procuff (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K140533: Galaflex Mesh (2014), 3 descendants of its own

## Recalls of this device
- Jan 8, 2013 · Class II · Z-0794-2013: Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured

## Indications for use
SeriScaffold surgical mesh 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.

Source page: https://510kreport.com/device/K080442
Methodology: https://510kreport.com/methodology