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Medpar Surgical Implants FWP

by Porex Medical

510(k) K832283

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 NumberK832283 Date10 May 1984ClearedStatusActive

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  • Withdrawn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)

Full name
Medpar Surgical Implants
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, 19 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 Medpar Surgical Implants FWP are classified as internal chin prostheses, designed to reconstruct or augment the mandible or chin region. These devices are intended for use in plastic and general surgery to restore form and function following trauma, congenital defects, or surgical resection.

Supplied as sterile, single-use implants, these devices are regulated under FDA 510(k) clearance K832283 with a classification of Class II. They fall under regulation 878.3550 and are intended for use in controlled surgical environments. The product code FWP identifies this specific line of chin prostheses, which require proper surgical placement and may vary in size and design to match patient anatomy.

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Questions

AI-generated answers, 19 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 types of medical procedures are these chin prostheses intended to support, and why are they considered single-use?

    These Medpar Surgical Implants (FWP) are designed for plastic and general surgery to reconstruct or augment the mandible or chin region after trauma, congenital defects, or surgical resection. They are classified as single-use due to their sterile packaging and intended use in controlled surgical environments, where contamination risks would compromise patient safety if reused.

  • Are these implants available in multiple sizes, and how does a surgeon determine the correct fit for a patient?

    Yes, the Medpar Surgical Implants come in various sizes and designs tailored to match individual patient anatomy. The exact sizing options are not specified in the data, but the implants are intended for custom placement by a surgeon during the procedure, ensuring proper reconstruction or augmentation of the chin or mandible region.

  • How should these implants be stored before use, and what precautions should be taken?

    Since these implants are supplied sterile and single-use, they should be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The sterile barrier must remain intact until immediately before use to prevent contamination, as per standard surgical implant handling protocols.

  • What regulatory pathway was followed for FDA clearance, and which advisory committee was involved?

    The Medpar Surgical Implants (K832283) received FDA clearance under the 510(k) pathway, specifically a *Traditional* review with a *Substantially Equivalent* determination. The submission was reviewed by the *Soft Tissue (SU) Advisory Committee* under the General and Plastic Surgery specialty, ensuring compliance with FDA regulations for internal chin prostheses (regulation 878.3550).