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MICRORAPTOR Knotless Suture Anchor

by Smith & Nephew, Inc.

510(k) K181746

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 NumberK181746 Date28 Sep 2018ClearedStatusActive

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  • Withdrawn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
FDA applicant
Smith and Nephew, Inc.
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Microraptor Knotless Suture Anchor is a fixation device designed for the reattachment of soft tissue to bone in various surgical procedures, including hip and shoulder repairs. It consists of a knotless suture anchor and an insertion device.

The device is supplied sterile and is intended for single-use. It is available in various sizes and is designed for off-axis insertion performance, with a full-length inserter and rigid implant design. The device has received FDA 510K authorization.

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