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Aims Cannulated Acl Screw

by Smith & Nephew, Inc.

510(k) K943539

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943539 Date19 Oct 1994ClearedStatusActive

Official records

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  • Withdrawn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
HWC
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Aims Cannulated ACL Screw is an orthopedic fixation device designed for internal stabilization of the anterior cruciate ligament (ACL) during reconstructive surgery. It features a cannulated screw, allowing for precise placement through a guide pin, which reduces the need for additional drilling. This device is intended for use in ligamentous repair procedures where secure fixation is required to restore knee stability.

This device is supplied as a single-use, sterile orthopedic implant and is classified under FDA product code HWC. It is intended for use in controlled surgical environments, such as operating rooms, and must be handled according to sterile protocols. The 7MM diameter variant is one of the available sizes, ensuring compatibility with various patient anatomies. Authorized under FDA 510(k) clearance (K943539), it adheres to regulatory standards for orthopedic fixation devices.

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