← Product Code [KTT](/productcode/KTT) · K070724 # IOS EXTERNAL FIXATOR, MODEL 2-0-0 (K070724) _Intelligent Orthopaedics, Ltd. · KTT · May 16, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K070724 ## Device Facts - **Applicant:** Intelligent Orthopaedics, Ltd. - **Product Code:** [KTT](/productcode/KTT.md) - **Decision Date:** May 16, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The IQS fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation. ## Device Story The iφs External Fixation Device is a single-use orthopedic system for bone fracture stabilization. The device consists of a main body with two available lengths (70mm and 110mm) featuring three 10mm diameter holes at each end. In clinical use, screw sleeves are inserted into these holes; bone screws are passed through the sleeves into bone fragments. A grub screw secures the bone screw to the fixator body. The device is applied by a surgeon to provide external skeletal stabilization. It functions as a mechanical support system to maintain bone alignment during the healing process. ## Clinical Evidence Bench testing only. ## Technological Characteristics Materials: titanium alloy and stainless steel. Form factor: main body with two lengths (70mm, 110mm) and six 10mm diameter screw holes. Fixation mechanism: screw sleeves and grub screws. Single-use device. ## 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 XFIX DFS system ([K031919](/device/K031919.md)) ## 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}------------------------------------------------ K070724 Page 15 MAY 16 2007 Image /page/0/Picture/2 description: The image shows a symbol that resembles the Greek letter phi (Φ, φ) with a dot above it. The symbol consists of a circle with a vertical line passing through its center. The dot is positioned directly above the vertical line, creating a distinct visual element. The symbol is rendered in black against a white background. PO Box 2681 Steke on Tient STA 988 T: +44 (0) 17 82 84 78 40 F: +44 (0) 17 82 54 60 46 www.intelligent.orthopaedics.co.uk # E) 510(k) Summary or 510(k) Statement Submitted by Peter Ogrodnik Managing Director Intelligent Orthopaedics Limited Building 103 Campbell Road Stoke on Trent Staffordshire ST4 4DE United Kingdom Date 8 February 2007 Contact person Julio Gonzalez BSN medical Inc 5285 Carnegie Blvd Charlotte NC | Proprietary Name | i\[phi]s External Fixation Device | |----------------------------|------------------------------------------------------------------------------------------------------| | Common Name | External Fixation Systems | | Classification / Reference | Class II – 888.3030 Single / Multiple Component Metallic
Bone Fixation Appliances and Accessories | | Product Code & Panel | KTT / Orthopedic | ## Device Description The ids fixator construct comprises of a main body which incorporates a central portion with larger ends with three 10mm diameter holes in each to accommodate bone screws. It is available in two lengths - 70 mm and 110mm. A screw sleeve fits into each hole and the bone screw is passed through each sleeve and into the bone fragment through the skin. The bone screw is secured to the fixator using a grub screw (passing through the sleeve) and tightening onto the screw directly. The ids fixator is a single use device. ## Intended Use The ids fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation Page 1 of 2 {1}------------------------------------------------ ## Technological characteristics The components of the iφs fixator are made from titanium alloy and stainless steel ## Substantial Equivalence The components of the ids fixator are substantially equivalent to K031919 – EBI XFIX DFS system. Equivalency is based on similarities in intended use, materials and design to the predicate devices and the mechanical performance demonstrating substantial equivalence to the predicate devices. Page 2 of 2 {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the edge. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Intelligent Orthopaedics Ltd. % Mr. Neil McLachlan BSN Medical Ltd. Brierfield Mill Brierfield, Nelson Lancashire BB9 5NJ United Kingdom MAY 16 2007 K070724 Re: > Trade/Device Name: I�S External Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: KTT Dated: April 30, 2007 Received: May 4, 2007 Dear Mr. McLachlan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must {3}------------------------------------------------ #### Page 2 - Mr. Neil McLachlan comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Barbara Buechner Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): K070724 Device Name: Indications for Use: The IQS fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation. Prescription Use X (Part 21 CFR 801 Subpart D) APC FESS AS TOLES FREE PARTER PLUS PERSONAL POST COLLECTION COLLECTION CONSECTION CONNECT AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) barbare buehum Division Sion-( Division of General. Restorative. and Neurological Devices Page 1 of 1 **510(k) Number** K070724 D-2 --- **Source:** [https://fda.innolitics.com/device/K070724](https://fda.innolitics.com/device/K070724) **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. 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