BTI Large (7.0MM) Cannulated Transfixing Screws

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

510(k) Number

K974756 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SN

• EZ-FIX Small Cannulated Screw System

  Class II

  FDA 510(k) K962987 Active Cleared 4 Nov 1996

• 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

See all devices from Biodynamic Technologies, Inc. →

• What is the primary clinical use for these cannulated transfixing screws, and how do they work in the body?

  These BTI Large (7.0mm) Cannulated Transfixing Screws are designed to stabilize humeral fractures by providing mechanical fixation within the bone. They are intended for use with BTI Humeral Intramedullary Rod systems, allowing secure transfixation to maintain alignment and stability during the healing process. The cannulated design enables them to be inserted over a guidewire or rod, ensuring precise placement within the humerus.

• Are these screws reusable, or are they meant for single-use only? How does this affect their clinical handling?

  These screws are explicitly classified as single-use devices, meaning they are intended for one-time implantation only. This classification ensures sterility and safety for each patient, reducing the risk of cross-contamination or degradation from repeated use. Clinicians should follow sterile handling protocols and discard them after use to comply with medical device regulations.

• What size and model variations are available for these screws, and how does the 7.0mm diameter factor into their application?

  The device listed is specifically the 7.0mm diameter cannulated transfixing screw, which is part of the BTI Large series. The 7.0mm diameter is designed to fit within the humerus for stable fixation of larger fractures, providing sufficient strength and purchase in bone. While this is the primary size mentioned, the manufacturer may offer other diameters or lengths as part of their broader humeral fixation system—clinicians should confirm availability with Biodynamic Technologies, Inc. for specific case requirements.

• How are these screws supplied, and what storage or handling precautions should be taken to maintain their sterility?

  The screws are supplied sterile, meaning they are packaged and sterilized by the manufacturer to prevent contamination before use. Since they are single-use, they should be stored in their original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Clinicians should check expiration dates and ensure the packaging remains intact until immediate preoperative use to preserve sterility.

• What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians or purchasing departments?

  These screws received FDA 510(k) clearance (K974756) under the Traditional review pathway, with a decision date of March 12, 1998. This means the device was determined to be substantially equivalent to a legally marketed predicate device for some indications, ensuring it meets FDA safety and effectiveness standards. Clinicians and purchasing departments can rely on this clearance as confirmation of the device’s regulatory compliance for orthopedic fracture fixation in the U.S., though they should always verify current listings with the FDA or manufacturer for updates.