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Medpor Plus Surgical Implant Biomaterial

by Porex Surgical, Inc.

510(k) K012350

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 NumberK012350 Date14 Mar 2002ClearedStatusActive

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  • Withdrawn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
FWP
Device Class
Class II
Regulation
21 CFR Part 878.3550
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 Plus Surgical Implant Biomaterial is a prosthesis, chin, internal, and is substantially equivalent to other devices. It is made of porous polyethylene and is used as an implant in surgical procedures. The device is a type of biomaterial and is used in various applications, including cranial, reconstructive, oculoplastic, and cosmetic procedures.

The Medpor Plus Surgical Implant Biomaterial is supplied by Porex Surgical, Inc. and has been authorized with an FDA 510K clearance. It is classified as a class 2 device and has a product code of FWP. The device is available in various sizes and is intended for use in general and plastic surgery applications. It has been used in over 400,000 procedures and has a comprehensive portfolio of facial implants.

Other devices from Porex Surgical, Inc.

See all devices from Porex Surgical, Inc. →

Questions

AI-generated answers, 1 Oct 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 Medpor Plus Surgical Implant Biomaterial made of?

    The Medpor Plus Surgical Implant Biomaterial is made of porous polyethylene, a type of biomaterial used in various surgical applications.

  • What are the intended uses of the Medpor Plus Surgical Implant Biomaterial?

    The device is intended for use in general and plastic surgery applications, including cranial, reconstructive, oculoplastic, and cosmetic procedures.

  • Is the Medpor Plus Surgical Implant Biomaterial available in different sizes?

    Yes, the Medpor Plus Surgical Implant Biomaterial is available in various sizes to accommodate different patient needs and surgical procedures.

  • How many procedures has the Medpor Plus Surgical Implant Biomaterial been used in?

    The Medpor Plus Surgical Implant Biomaterial has been used in over 400,000 procedures, demonstrating its widespread use and acceptance in the medical community.