Aims Cannulated ACL Screw (7MM Diameter)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K945236 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K962462 Active Cleared 23 Sep 1996

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  FDA 510(k) K932592 Active Cleared 18 Mar 1994

• Protective Restraint

  Class I

  FDA 510(k) K963492 Active Cleared 12 Nov 1996

• Musclesense Electromyography Device

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  FDA 510(k) K951350 Active Cleared 23 Jun 1995

• Rounded Cannulated Inside-Out (Rci) Acl Screw

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  FDA 510(k) K932862 Active Cleared 10 Mar 1994

• Musclesense II Clinical Electromyography Device

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  FDA 510(k) K970051 Active Cleared 10 Jul 1997

See all devices from Smith and Nephew Donjoy, Inc. →

• What is the AIMS Cannulated ACL Screw used for?

  The AIMS Cannulated ACL Screw is a medical device designed specifically for anterior cruciate ligament (ACL) reconstruction surgeries. It provides fixation for the ligament during orthopedic procedures to help stabilize the knee joint.

• Is the AIMS Cannulated ACL Screw reusable or single-use?

  This device is supplied as a single-use implant only. It should not be reused on multiple patients as this could compromise sterility and device integrity, potentially leading to surgical complications or patient safety issues.

• What are the key specifications of the AIMS Cannulated ACL Screw?

  The AIMS Cannulated ACL Screw has a 7mm diameter and is manufactured by Smith and Nephew Donjoy, Inc. It is not MRI safe, meaning patients with this implant should not undergo MRI scans as it could interfere with the imaging process or potentially cause injury.

• What regulatory approvals does the AIMS Cannulated ACL Screw have?

  The device is authorized under FDA 510K clearance with product code HWC. This clearance indicates that the device is substantially equivalent to legally marketed predicate devices, though it does not represent FDA approval or endorsement of the device's safety or effectiveness.