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Biosorbfx and Biosorbpdx Mesh

by Bionx Implants, Inc.

510(k) K010687

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 · Special NumberK010687 Date14 Mar 2001ClearedStatusActive

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  • Withdrawn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
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
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 Biosorbfx and Biosorbpdx Mesh is a bone plate designed for dental applications, intended to support and stabilise bone segments during healing. Constructed as a mesh material, it facilitates osseointegration and structural reinforcement in maxillofacial or mandibular reconstruction procedures, aiding in the restoration of anatomical integrity.

Supplied as a single-use, sterile device, the mesh is classified under FDA regulation 872.4760 and falls under Class II medical devices. It is intended for use in controlled surgical environments, with specific sizes referenced in the registration database. The device holds an FDA 510(k) clearance (K010687) under the Dental advisory committee, granted in 2001, and is distributed under product code JEY.

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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 dental procedures is the BIOSORBFX AND BIOSORBPDX Mesh designed to support during bone healing?

    The BIOSORBFX AND BIOSORBPDX Mesh is specifically designed for maxillofacial or mandibular reconstruction procedures. It supports and stabilizes bone segments during healing, aiding in osseointegration and structural reinforcement to restore anatomical integrity in these areas.

  • Is the BIOSORBFX AND BIOSORBPDX Mesh intended for single-use or can it be reused?

    The BIOSORBFX AND BIOSORBPDX Mesh is supplied as a single-use, sterile device. It is not intended for reuse, ensuring patient safety and compliance with surgical best practices.

  • What sizes or models of the BIOSORBFX AND BIOSORBPDX Mesh are available?

    The mesh comes in multiple sizes, as referenced by the listed FEI numbers (e.g., 3011302692, 3003322138, etc.) in the regulatory database. These sizes are tailored for specific maxillofacial or mandibular reconstruction applications, allowing for customization based on surgical needs.

  • How should the BIOSORBFX AND BIOSORBPDX Mesh be stored to maintain its sterility?

    Since the mesh is supplied sterile and intended for single-use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Follow manufacturer guidelines to preserve sterility until use.

  • What regulatory pathway was followed for the FDA clearance of the BIOSORBFX AND BIOSORBPDX Mesh?

    The device received FDA clearance through a 510(k) pathway (K010687) under the Dental advisory committee, classified as substantially equivalent to a predicate device. It was granted in 2001 and falls under product code JEY, categorized under FDA regulation 872.4760 as a Class II medical device.