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Bone Anchor System For Soft Tissue Support

by Boston Scientific

510(k) K971139

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 NumberK971139 Date25 Jun 1997ClearedStatusActive

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  • Withdrawn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
MBI
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Bone Anchor System for Soft Tissue Support is a medical device designed for soft tissue reinforcement and support. It facilitates the attachment of sutures to bone during surgical procedures.

This system is used in surgical interventions such as pelvic floor reconstruction, prolapse repair, and the treatment of urinary stress incontinence. The device has received FDA 510(k) clearance.

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Questions

AI-generated answers, 25 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 of the Bone Anchor System?

    This system is designed to provide soft tissue reinforcement and support by facilitating the attachment of sutures to bone. It is specifically indicated for use in surgical procedures including pelvic floor reconstruction, prolapse repair, and the treatment of urinary stress incontinence.

  • What is the regulatory status of this device?

    The Bone Anchor System for Soft Tissue Support has received FDA 510(k) clearance. It was determined to be substantially equivalent to existing devices under the traditional clearance pathway, as recorded under K-number K971139.

  • Which medical specialty oversees this device category?

    The device is categorized under the Orthopedic advisory committee, which oversees the regulatory review process for this specific product code, MBI, to ensure it meets the necessary standards for clinical use.