Skip to content

Anatomical Bankart Tack, Model 523520A

by Bionx Implants, Ltd.

510(k) K992567

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 · Special NumberK992567 Date27 Aug 1999ClearedStatusActive

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  • Withdrawn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.

The Anatomical Bankart Tack, Model 523520A, is a biodegradable soft tissue fixation fastener. It is designed to provide internal fixation of soft tissue to bone for the repair of anterior shoulder instability, specifically for the reattachment of the glenoid labrum or inferior glenohumeral ligaments in patients with Bankart lesions.

This device is intended for use in patients experiencing primary or recurrent anterior shoulder dislocation or subluxation. It is manufactured by Bionx Implants, Ltd. and has received FDA 510(k) clearance.

Other devices from Bionx Implants, Inc.

See all devices from Bionx Implants, Inc. →

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 the primary clinical use for the Anatomical Bankart Tack?

    This device is designed for the internal fixation of soft tissue to bone. It is specifically indicated for the repair of anterior shoulder instability, including the reattachment of the glenoid labrum or inferior glenohumeral ligaments in patients suffering from Bankart lesions, recurrent dislocation, or subluxation.

  • What material is the device made of?

    The Anatomical Bankart Tack is a biodegradable soft tissue fixation fastener. This material property allows the device to provide necessary fixation while being intended for absorption by the body over time.

  • What is the regulatory status of this device?

    The Anatomical Bankart Tack, model 523520A, manufactured by Bionx Implants, Ltd., has received FDA 510(k) clearance under the regulation number 888.3030.