← Product Code [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT) · K961433 # EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS (K961433) _Electro-Biology, Inc. · KTT · Jun 28, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K961433 ## Device Facts - **Applicant:** Electro-Biology, Inc. - **Product Code:** [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT.md) - **Decision Date:** Jun 28, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: (201) 331-3904 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.)] --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K961433](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K961433) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com