Arthroscopic Surgical Instruments – Interference Screw Systems

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

510(k) Number

K122596 ↗

FDA product code

HWC

Device class

Class II

Regulation

21 CFR Part 888.3040

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

• Real Intelligence ROB30801

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• Real Intelligence ROB30007

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-01

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-04

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-03

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-02

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

See all devices from Smith & Nephew, Inc. →

• What is the primary use of the Smith & Nephew Interference Screw System?

  The Smith & Nephew Interference Screw System is designed specifically for arthroscopic procedures to secure soft tissue or tendon grafts to bone during joint repair surgeries, such as ACL reconstruction. It provides stable fixation to resist pull-out forces, ensuring long-term stability in minimally invasive orthopedic applications. This reduces trauma to surrounding tissues and helps accelerate patient recovery by maintaining graft position.

• How is the Interference Screw System supplied, and what does this mean for clinical use?

  The system is supplied sterile for single-use only, adhering to standard surgical sterility protocols. This means each package is intended for one surgical procedure and must not be reused or reprocessed. Sterile single-use devices minimize infection risks and ensure consistent performance, which is critical in arthroscopic surgeries where precision and reliability are essential.

• Are these screws compatible with MRI imaging, and why does this matter?

  Yes, the Smith & Nephew Interference Screw System is designed to be MRI-compatible, meaning it can be safely used in patients who require postoperative MRI scans. This is particularly important for orthopedic procedures like ACL reconstruction, where follow-up imaging is often necessary to assess graft integration and joint stability. MRI compatibility ensures patients can undergo these scans without risking damage to the fixation hardware.

• What sizes and configurations are available, and how do they relate to arthroscopic access?

  The system includes sizes and configurations specifically tailored for arthroscopic access, ensuring compatibility with existing surgical tools and techniques. These designs allow surgeons to perform precise fixation through small incisions, reducing soft tissue damage and improving patient outcomes. The configurations are optimized to fit common arthroscopic portals and graft sizes used in procedures like ACL reconstruction.

• How should the Interference Screw System be stored to maintain sterility and functionality?

  Storage follows standard surgical instrument protocols to preserve sterility and functionality. This typically involves keeping the sterile packages in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use, and any exposed or compromised packages should be discarded to prevent contamination. Proper storage ensures the screws retain their structural integrity and sterility for reliable performance during surgery.