EZ-FIX Small Cannulated Screw System

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

510(k) Number

K962987 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Shoulder-Holder

  Not classified

  FDA 510(k) K851206 Active Cleared 25 Apr 1985

• Universal Power Flex

  Class I

  FDA 510(k) K851177 Active Cleared 28 Jun 1985

• Biodynamics Femoral Canal Brush #1201

  Class I

  FDA 510(k) K870349 Active Cleared 13 Feb 1987

• Universal Bone Cement Kit

  Class II

  FDA 510(k) K931540 Active Cleared 27 Jan 1994

• Anatomic Proportional Shoulder APS (Hemi-Shoulder) System

  Class II

  FDA 510(k) K935593 Active Cleared 14 Oct 1994

• Osteomill Bone Grinder

  Class I

  FDA 510(k) K861164 Active Cleared 2 May 1986

See all devices from Biodynamic Technologies, Inc. →

• What types of bones and joints can the EZ-FIX Small Cannulated Screw System be used to stabilize, and why is this system designed for those specific areas?

  The EZ-FIX Small Cannulated Screw System is designed for fracture stabilization in long bones and joints such as the femur, tibia, pelvis, acetabulum, shoulder, and elbow. Its cannulated design allows for precise placement over a 3.2 mm guide pin, making it ideal for complex fractures in these areas where accurate screw positioning is critical for proper healing and fixation.

• Is the EZ-FIX Small Cannulated Screw System intended for single-use or reusable applications, and how does this affect its clinical use?

  The EZ-FIX Small Cannulated Screw System is explicitly described as a reusable orthopedic implant, meaning it is intended for multiple uses in controlled surgical settings. This design reduces waste and cost per procedure while maintaining sterility through proper cleaning and reprocessing protocols, which is essential for maintaining clinical safety in repeated applications.

• What are the key dimensions of the EZ-FIX Small Cannulated Screw, and how do these specifications ensure compatibility with standard orthopedic tools?

  The screws feature a 7.3 mm thread diameter, a 20 mm thread length, and a 3.45 mm cannulation designed to accommodate a 3.2 mm guide pin. These measurements ensure precise alignment with existing orthopedic instrumentation, allowing surgeons to use familiar guide pins and drills while achieving stable fixation in small bone fragments or joint repairs.

• How is the EZ-FIX Small Cannulated Screw System regulated, and what does its FDA clearance under product code HWC indicate about its intended use?

  The system holds an FDA 510(k) clearance under product code HWC (Orthopedic Fixation Devices), granted on November 4, 1996, with a determination of substantial equivalence to a predicate device. This classification confirms its compliance with U.S. regulatory standards for orthopedic fracture fixation, though it does not specify clinical indications—only that it meets FDA requirements for orthopedic use in controlled surgical environments.