← Product Code [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT) · K960014 # PRACTIFIX EXTERNAL FIXATION SYSTEM (K960014) _Orthopaedic Innovations, Inc. · KTT · Mar 18, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K960014 ## Device Facts - **Applicant:** Orthopaedic Innovations, Inc. - **Product Code:** [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT.md) - **Decision Date:** Mar 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur. ## Device Story External fixation system; utilizes AISI 316L stainless steel pins and carbon-fiber tubes; components connected via pin clamps and bar-bar clamps. System configured to bridge long-bone fractures or non-unions; provides mechanical stability to facilitate bone/soft tissue healing. Operated by surgeons in clinical settings; provides rigid external support for bone segments. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and material characteristics. ## Technological Characteristics Materials: AISI 316L stainless steel pins, carbon-fiber tubes. Components: pin clamps, bar-bar clamps. Function: mechanical external fixation/bridging. Sterilization: not specified. ## 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 - Hex-Fix External Fixation (Smith and Nephew Richards) - Day External Fixation (DePuy) - AP/ASIF External Fixation System (Synthes) ## 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} 510(K) Summary of Safety and Effectiveness R 960014 Submitter: Orthopaedic Innovations, Inc. 825 South 8th Street, Suite 700 Minneapolis, MN 55404 Telephone: (612) 672-0021 Contact: Carolyn M. Steele Date of Summary: 12/28/95 MAR 18 1996 Product: Classification Name: Single/multiple component metallic bone fixation appliances and accessories - (21 CFR 88.3030) Common Name: External Fixation System Trade/Proprietary Name: Practifix External Fixation System Substantially Equivalent Products Hex-Fix External Fixation by Smith and Nephew Richards Day External Fixation by DePuy AP/ASIF External Fixation System by Synthes Description The product consists of AISI 316L stainless steel pins inserted above and below the fracture site. The carbon-fiber tubes in combination with pin clamps act to hold the transfixation pins at the desires angle and position. Bar-bar clamps are used to combine additional carbon fiber tubes in the desired configuration Intended Use: This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur. Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects. Comparison to Substantial Equivalent Products: All made of the same types of materials, equivalent in function and design. d:\FDA\Corresp\510\lexfix081595 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K960014](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K960014) **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