EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS

K961433 · Electro-Biology, Inc. · KTT · Jun 28, 1996 · Orthopedic

Device Facts

• Record ID: K961433
• Device Name: EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS
• Applicant: Electro-Biology, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Jun 28, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI X FIX DynaFix System is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The EBI DFS™ Distal Radius Fixator is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

Device Story

System consists of tapered-thread bone screws (cortical/cancellous patterns) for external fixation; available with/without proprietary silver coating to reduce bacterial colonization. Used by surgeons in clinical settings for bone stabilization/fixation. Silver coating applied via proprietary process (MAF-480). Device provides mechanical support for bone healing; silver coating acts as antimicrobial surface treatment. Output is physical stabilization of bone segments.

Clinical Evidence

Bench testing only. Includes biocompatibility, fatigue, and direct inoculation testing to evaluate the silver coating's performance.

Technological Characteristics

Materials: Stainless steel 316L (ASTM F138). Proprietary silver coating (MAF-480). Tapered thread design; various diameters/lengths. Sterile and non-sterile options.

Indications for Use

Indicated for patients requiring external fixation for bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and upper extremity applications for reduction, alignment, and stabilization of intra-articular and extra-articular fractures and soft tissue deformities.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• EBI X FIX™ DynaFix™ System and DFS™ Distal Radius Fixator Bone Screws
• Vitaphore SilverFoam Wound Dressing
• Genetic Laboratories E-Z DERM™ Temporary Skin Substitute with Silver
• Arrow Antimicrobial Multi-Lumen Central Venous Catheter
• Vitaphore Pin Protection Device

Submission Summary (Full Text)

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K961433

JUN 28 1996

# 510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI X FIX™ DynaFix™ System and EBI DFS™ Distal Radius Fixator is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

1. Submitter: Electro-Biology, Inc.
6 Upper Pond Road
Parsippany, NJ 07054

Contact Person: Sharon A. Starowicz
Telephone: [phone]

Date prepared: June 26, 1996

2. Proprietary Name: EBI X FIX™ DynaFix™ System - SC Bone Screws
EBI DFS™ Distal Radius Fixator - SC Bone Screws
Common Name: External Fixation Bone Screws
Classification Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories (888.3030)

3. Predicate or legally marketed devices that are substantially equivalent:

- EBI X FIX™ DynaFix™ System and DFS™ Distal Radius Fixator Bone Screws
- Vitaphore SilverFoam Wound Dressing
- Genetic Laboratories E-Z DERM™ Temporary Skin Substitute with Silver
- Arrow Antimicrobial Multi-Lumen Central Venous Catheter
- Vitaphore Pin Protection Device

4. Description of the device: The bone screws have a tapered thread diameter and are available in a variety of diameters and lengths in both cortical and cancellous thread patterns. The screws will be available with and without the additional proprietary silver coating which has been shown to significantly reduce bacterial colonization of the surface, and will be sold sterile and nonsterile.

Intended Use: The EBI X FIX DynaFix System is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The EBI DFS™ Distal Radius Fixator is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

5. Materials: The SC bone screws are manufactured from stainless steel, 316L per ASTM F138. The silver coating is applied by a proprietary process according to Device Master File MAF-480.

6. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the SC bone screws and other currently marketed bone screws. The addition of the silver coating will not adversely affect the use of the bone screws. The coated screws underwent biocompatibility, fatigue, and direct inoculation testing. They are substantially equivalent* to the predicate devices in design and function.

*Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]