# K021056: Permacol

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Science Laboratories, Plc
- Decided: Oct 31, 2002 after 213 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: 5 generations back to K921895 (1992). 24 ancestors in all.
51 later devices descend from it; 4 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K011025: Fortaflex Surgical Mesh, Organogenesis, Inc. (2001)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.

## Most influential descendants
- K053562: Zimmer Collagen Repair Patch (2006), 41 descendants of its own
- K071887: Sportmesh or Artelon Tissue Reinforcement (2007), 28 descendants of its own
- K070961: Biomerix Surgical Mesh, Model: RCR-01 (2008), 17 descendants of its own
- K072370: Surgicraft Surgical Mesh System (2008), 11 descendants of its own
- K192112: FlexBand Plus (2019), 9 descendants of its own

## Indications for use
Permacolm' - Crosslinked Porcine Dermal Collagen Surgical Mesh is indicated for use in the reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

Source page: https://510kreport.com/device/K021056
Methodology: https://510kreport.com/methodology