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

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K050355 ↗

FDA Product Code

PAI

Device Class

Class III

Regulation

21 CFR Part 884.5980

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Permacol

  Class II

  FDA 510(k) K992556 Active Cleared 17 Feb 2000

• Permacol Surgical Implant

  Class II

  FDA 510(k) K043366 Active Cleared 17 Dec 2004

• Zimmer Collagen Repair Patch

  Class II

  FDA 510(k) K053562 Active Cleared 23 Jun 2006

• Permacol Surgical Mesh

  Class II

  FDA 510(k) K013625 Active Cleared 17 Jan 2002

• Permacol Surgical Mesh

  Class II

  FDA 510(k) K021056 Active Cleared 31 Oct 2002

• What types of surgical procedures are these Permacol implants designed to support, and how do their shapes help in those applications?

  The Permacol Surgical Implant T-Piece and Rectocele-Piece are specifically designed for transvaginal pelvic organ prolapse repair. The T-Piece is shaped to reinforce soft tissue in complex anatomical areas, while the Rectocele-Piece targets prolapse involving the rectum, providing tailored structural support to address these distinct anatomical requirements during urogynecologic surgeries.

• Are these implants reusable, or are they meant for single-use only? How should they be stored to maintain sterility?

  These implants are intended for single-use only, as explicitly stated in the product description. To maintain sterility, they must be stored and handled according to standard sterile medical device protocols, ensuring their integrity is preserved until use in a surgical setting.

• What materials are used in the construction of these implants, and why is this material choice significant?

  The Permacol implants are constructed from a crosslinked acellular porcine dermal collagen matrix, which is a non-synthetic material. This choice is significant because it provides a biocompatible scaffold for tissue integration, reducing the risk of adverse reactions while offering structural reinforcement during pelvic floor reconstruction.

• How are the models 5928-150 and 5645-150 differentiated, and what considerations should a clinician keep in mind when selecting between them?

  The models 5928-150 and 5645-150 are predefined sizes tailored for specific surgical applications in pelvic organ prolapse repair. While the exact anatomical differences between the models aren’t detailed, the distinction likely relates to the anatomical region or complexity of the prolapse being addressed. Clinicians should select the model based on the patient’s specific prolapse type and surgical requirements, ensuring the implant’s shape aligns with the anatomical needs of the procedure.

• What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians using these implants?

  The Permacol implants were cleared via a Special 510(k) pathway, with substantial equivalence established to predicate devices. This means the FDA determined they are as safe and effective as existing approved devices for their intended use in transvaginal pelvic organ prolapse repair. Clinicians can rely on this clearance as evidence of the implants’ regulatory review and compliance with FDA standards for urogynecologic mesh devices.