# K043259: Bioblanket Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Aug 15, 2005 after 264 days
- Product code: FTM (Mesh, Surgical)
- 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: 6 generations back to K921895 (1992). 28 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041923: Bioblanket, Kensey Nash Corp. (2004) Summary page 1.
- K020049: Fortaflex Surgical Mesh, Organogenesis, Inc. (2002) Summary page 1.
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K061030: Bioblanket Surgical Mesh (2006), 4 descendants of its own
- K091499: Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry) (2009), 3 descendants of its own
- K103787: Medeor Matrix (2011), 2 descendants of its own
- K082079: Regen Collagen Scaffold (CS) (2008), 2 descendants of its own
- K170364: Collagen Meniscus Implant XL (2017), 1 descendant of its own

## Indications for use
BioBlanket™ Surgical Mesh is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to defects of the thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one time use.

Source page: https://510kreport.com/device/K043259
Methodology: https://510kreport.com/methodology