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BIODUCT

by Bioduct, LLC

510(k) K053492

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK053492 Date12 Apr 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
MAI
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

BIODUCT is a biodegradable fastener for soft tissue fixation, classified as a Class II medical device under the Orthopedic specialty. It received FDA 510(k) clearance (K053492) on April 12, 2007, as substantially equivalent to a predicate device.

The device is supplied non-sterile and is intended for single-use applications in orthopedic procedures. It is manufactured by Bioduct, LLC in Fort Wayne, Indiana, and is regulated under FDA product code MAI and regulation number 888.3030.

Questions

AI-generated answers, 23 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 BIODUCT used for?

    BIODUCT is a biodegradable fastener intended for soft tissue fixation in orthopedic procedures, as indicated by its classification under the Orthopedic specialty and its FDA 510(k) clearance as substantially equivalent to a predicate device for this use.

  • Is BIODUCT sterile or non-sterile, and is it for single-use or reuse?

    BIODUCT is supplied non-sterile and is intended for single-use applications only, as explicitly stated in the device description, meaning it must be sterilized by the user before use and should not be reused after initial application.

  • What regulatory pathway and product code apply to BIODUCT?

    BIODUCT received FDA 510(k) clearance (K053492) on April 12, 2007, is classified as a Class II device, and is regulated under FDA product code MAI and regulation number 888.3030, which governs biodegradable soft tissue fixation devices.