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K Number
K972403
Device Name
BTI CORTICAL BONE SCREWS
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1997-08-29

(64 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BTI™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI Compression Hip Screw System, BTI Humeral Intramedullary Rod Systems, and the BTI Distal Femoral Intramedullary Rod System.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the BTI™ Cortical Bone Screws. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI assistance or human-in-the-loop performance.

The letter primarily focuses on:

  • The FDA's determination of substantial equivalence for the BTI™ Cortical Bone Screws to previously marketed devices.
  • The device's regulatory classification (Class II).
  • Important disclaimers and warnings regarding the unapproved use of the device for pedicular screw fixation/attachment, stating that such use would be considered investigational and would require specific regulatory approvals.
  • General controls and regulations applicable to the device.
  • The indications for use for which the device is approved.

Therefore, I cannot provide the requested information, as it is not present in the given document.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.