# K050355: Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150

- Pathway: 510(k) (Special)
- Applicant: Tissue Science Laboratories, Plc
- Decided: Mar 9, 2005 after 23 days
- Product code: PAI (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921895 (1992). 13 ancestors in all.
54 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992556: Permacol, Tissue Science Laboratories, Plc (2000) Summary page 2.
- K043366: Permacol Surgical Implant, Tissue Science Laboratories, Plc (2004) Summary page 2.

## Most influential descendants
- K070560: LRTM Surgical Mesh (2007), 50 descendants of its own
- K082176: LTM-BPS Surgical Mesh (2008), 14 descendants of its own
- K142326: HP Tissue Matrix (2014), 11 descendants of its own
- K151083: BioBridge Collagen Matrix (2016), 9 descendants of its own
- K082103: LTM Wound Dressing (2008), 7 descendants of its own

## Indications for use
Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocele-pieces are shaped for use in rectocele repair.

Source page: https://510kreport.com/device/K050355
Methodology: https://510kreport.com/methodology