BTI Distal Femoral Intramedullary Rod System

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

510(k) Number

K970897 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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 types of distal femoral fractures is this intramedullary rod system designed to treat, and how does it support healing?

  The BTI Distal Femoral Intramedullary Rod System is specifically designed for internal fixation of distal femoral fractures, providing stable alignment and structural support to the bone during the healing process. By maintaining proper skeletal alignment, it facilitates optimal bone restoration and helps restore weight-bearing functionality, which is critical for recovery and mobility.

• Is this device reusable or single-use, and what does that mean for surgical planning?

  The BTI Distal Femoral Intramedullary Rod System is supplied as a reusable surgical implant. This means it is intended to be used in multiple procedures after proper cleaning, sterilization, and inspection, reducing costs and waste compared to single-use devices. However, reuse requires strict adherence to manufacturer guidelines for reprocessing to ensure safety and efficacy.

• What regulatory pathway was followed for FDA clearance, and how does that affect its classification?

  The BTI Distal Femoral Intramedullary Rod System received FDA clearance under the traditional 510(k) review pathway, classified under product code HSB and regulated as a Class II medical device. This pathway involves a detailed comparison to a legally marketed predicate device, ensuring the system meets established safety and performance standards for orthopedic intramedullary fixation.

• How does the system’s design ensure compatibility with standard orthopedic surgical techniques?

  The system’s design adheres to orthopedic standards for intramedullary fixation, meaning it is engineered to integrate seamlessly with conventional surgical tools, techniques, and equipment. This ensures surgeons can use familiar approaches while benefiting from the rod’s stability and alignment support for distal femoral fractures.