SYNTHES STERILE 4.5 MM CANNULATED SCREWS

K963172 · Synthes (Usa) · HWC · Nov 8, 1996 · Orthopedic

Device Facts

• Record ID: K963172
• Device Name: SYNTHES STERILE 4.5 MM CANNULATED SCREWS
• Applicant: Synthes (Usa)
• Product Code: HWC · Orthopedic
• Decision Date: Nov 8, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Synthes 4.5 mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.

Device Story

Device: 4.5 mm cannulated screws; stainless steel or Ti alloy construction. Input: guide wire for precise placement. Operation: self-drilling/self-tapping flutes; cancellous threads. Output: mechanical fixation of long bone fractures. Usage: clinical setting; orthopedic surgeon. Benefit: precise placement via guide wire; stabilization of bone fragments.

Clinical Evidence

Bench testing only; mechanical testing performed to demonstrate equivalence to predicate.

Technological Characteristics

Materials: stainless steel or Ti alloy. Features: 4.5 mm diameter, cannulated design, self-drilling/self-tapping flutes, cancellous threads. Sterilization: gamma radiation.

Indications for Use

Indicated for fracture fixation of long bones and long bone fragments in patients requiring internal fixation of cancellous bone.

Regulatory Classification

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.

Predicate Devices

• Synthes 4.0 mm Cancellous Screws

Submission Summary (Full Text)

{0}

NOV. -06' 96 (WED) 16:50 SYNTHES M96 3172 TEL: [phone] P. 003

NOV - 8 1996

Attachment B: Summary of Safety and Effectiveness Information

Synthes (USA) (610) 647 - 9700
1690 Russell Road Contact: Angela J. Silvestri
P.O. Box 1766 August 1996
Paoli, PA 19301

Synthes Sterile 4.5 mm Cannulated Screws are compared to Synthes 4.0 mm Cancellous Screws.

Synthes 4.5 mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments. Synthes 4.5 mm Cannulated Screws are available in various thread length configurations (partially or fully threaded). The 4.5 mm Cannulated Screw features self-drilling/self-tapping flutes and cancellous threads for use in cancellous bone. The screws are used in conjunction with a guide wire for precise placement in bone. Synthes 4.5 mm Cannulated Screws are manufactured from stainless steel or Ti Alloy.

Synthes 4.5 mm Cannulated Screws will be provided sterile, gamma radiation will be used to sterilize the device.

Based on mechanical testing, Synthes 4.5 mm Cannulated Screws are at least equivalent to Synthes 4.0 mm Cancellous Screws.