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Medpor Pterional Surgical Implant

by Porex Surgical Products Group

510(k) K002586

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002586 Date17 Nov 2000ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MNF
Device Class
Class II
Regulation
21 CFR Part 878.3550
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medpor Pterional Surgical Implant is a temporal implant designed for use in plastic and reconstructive surgery. It is constructed from high-density porous polyethylene to provide a biocompatible material for aesthetic, reconstruction, and augmentation needs.

This device is supplied as an off-the-shelf implant and has received FDA 510(k) clearance under K002586. It is manufactured by Porex Surgical Products Group and is categorized under regulation number 878.3550.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical application for the Medpor Pterional Surgical Implant?

    This implant is specifically designed for use in plastic and reconstructive surgery. It serves as a biocompatible material intended to address aesthetic, reconstruction, and augmentation needs within the temporal region.

  • What material is used to construct the Medpor Pterional Surgical Implant?

    The device is constructed from high-density porous polyethylene. This material is utilized for its biocompatibility, making it suitable for surgical implantation during reconstructive or augmentation procedures.

  • How is the Medpor Pterional Surgical Implant supplied to clinicians?

    The device is supplied as an off-the-shelf implant, allowing for immediate availability for surgical use. It is manufactured by the Porex Surgical Products Group and has received FDA 510(k) clearance under K002586.