SYNTHES 7.0/7.3 MM CANNULATED SCREWS

K962011 · Synthes (Usa) · HWC · Aug 5, 1996 · Orthopedic

Device Facts

• Record ID: K962011
• Device Name: SYNTHES 7.0/7.3 MM CANNULATED SCREWS
• Applicant: Synthes (Usa)
• Product Code: HWC · Orthopedic
• Decision Date: Aug 5, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 7.0/7.3 mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments.

Device Story

Cannulated screws for large bone fracture fixation; used with guide wire for precise placement. Features reverse cutting flutes and cancellous threads; 7.3 mm version includes self-drilling/self-tapping flutes. Operated by orthopedic surgeons in clinical/OR settings. Provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

Bench testing only; mechanical testing demonstrated equivalence to predicate 6.5 mm Cancellous Screws.

Technological Characteristics

Materials: Stainless steel, titanium alloy. Design: Cannulated, cancellous threads, reverse cutting flutes, self-drilling/self-tapping flutes (7.3 mm). Sterilization: Gamma radiation.

Indications for Use

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

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 6.5 mm Cancellous Screws

Reference Devices

• Ace 6.5 mm Ti Cannulated Cancellous Screw System
• Richards 8.0 mm Cannulated Screw
• Zimmer Magna-Fx Cannulated Screw Fixation System

Submission Summary (Full Text)

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SYNTHES K962011 AUG - 5 1996

# Attachment VI: Summary of Safety and Effectiveness Information

| Synthes (USA) | (610) 647 - 9700 |
| --- | --- |
| 1690 Russell Road | Contact: Angela J. Silvestri |
| P.O. Box 1766 | May 21, 1996 |
| Paoli, PA 19301 | |

Synthes Sterile 7.0/7.3 mm Cannulated Screws are compared to Synthes 6.5 mm Cancellous Screws.

Synthes 7.0/7.3 mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments. Synthes 7.0/7.3 mm Cannulated Screws are available in multiple thread length configurations (16 mm, 32 mm or fully threaded). Both Screws feature reverse cutting flutes and cancellous threads. Additionally, the 7.3 mm Cannulated Screw features self-drilling/self-tapping flutes. Both screws are used in conjunction with a guide wire for precise placement in bone. Synthes 7.0/7.3 mm Cannulated Screws are manufactured from stainless steel. The 7.3 mm Cannulated Screw is also available in a titanium alloy.

Additionally, the Ace 6.5 mm Ti Cannulated Cancellous Screw System, the Richards 8.0 mm Cannulated Screw, and Zimmer Magna-Fx Cannulated Screw Fixation System are commercially available devices that are also similar to the 7.0/7.3 mm Cannulated Screws.

Synthes 7.0/7.3 mm Cannulated Screws will be provided sterile; Gamma radiation will be used to sterilize the device.

Based on mechanical testing, Synthes 7.0/7.3 mm Cannulated Screws are at least equivalent to Synthes 6.5 mm Cancellous Screws.