← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K022597 # K-FIX (K022597) _New Deal, S.A. · HTY · Nov 1, 2002 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K022597 ## Device Facts - **Applicant:** New Deal, S.A. - **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md) - **Decision Date:** Nov 1, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic ## Intended Use The wire protecting caps K-FIX® are indicated for use in the protection of protruding ends of wires. Examples of protruding wires include: Osteotomies, arthrodesis or fractures management in the foot or hand. Fixation of small bone fragments, in long bones or small bones fractures. ## Device Story K-Fix is a polymer-based pin protector designed to cover sharp ends of surgical K-wires; prevents injury to patients and hospital staff; reduces bandage bulk. Features a patented 'Push, Lock and Twist' mechanism requiring no instruments for fixation. Optional configuration allows use on right-angle bent wires, facilitating manual rotational and axial maneuvers for pin removal. Delivered sterile; used intraoperatively to protect surgeons from cuts/pricks during multi-wire placement in confined areas. Device is external; fits comparable wire diameter ranges as predicate devices. ## Clinical Evidence No clinical data. Substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices. ## Technological Characteristics Polymer-based external protective cap; 'Push, Lock and Twist' mechanical fixation system; sterile delivery; compatible with various K-wire diameters. ## Regulatory 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 - K-CAP-ES external protective caps ([K914812](/device/K914812.md)) - Jurgan pin Ball® ([K831072](/device/K831072.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}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for New Deal. The logo consists of the word "newdeal" in a sans-serif font, with a circle of five dots to the left of the word. The "R" in a circle is to the right of the word. NEWDEAL SA . 31, RUE DE LA CONVENTION PARC D'ACTIVITÉS GARIGLIANO 3 8 2 0 0 0 VIENNE ● ● FRANCE TEL : +33 (0) 4 74 78 15 15 FAX : +33 (0) 4 74 78 15 16 w w w . neew deeal . i n f o Емать : пе w d e alfr @ a o l . c o m ### SUMMARY OF SAFETY AND EFFECTIVENESS 3. - SPONSOR IDENTIFICATION A. NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE Tél.: (33) 4 74 78 15 15 Fax: (33) 4 74 78 15 16 #### B. ESTABLISHMENT REGISTRATION NUMBER: 9615741 - C. OFFICIAL CONTACT PERSON Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 Tel.: (301) 279 -2899 Fax: (301) 294-0126 #### D. DATE OF PREPARATION OF THIS SUMMARY: August 3, 2002 - E. PROPRIETARY (TRADE) NAME: K-FIX® - F. COMMON NAME: K-Wire End Protector - G. CLASSIFICATION NAME AND REFERENCE Smooth or threaded metallic bone fixation fastener - H. PROPOSED REGULATORY CLASS : Class II - DEVICE PRODUCT CODE: I. LYT HTY - J. REFERENCE: 21 CFR par. 888.3040 - K. PANEL CODE: 87 OR Orthopedic 1 01 0009 {1}------------------------------------------------ ×022597 #### L. DESCRIPTION OF DEVICE: The K-Fix® pin protector is a simple and reliable system to protect patients or hospital staff from K-wire sharp ends and reduce bandages size. It presents an ergonomic profile. Thanks to its patented "Push, Lock and Twist" system, its fixation requires no instrument. An optional possibility for using K-Fix on wires bent at right angle allows manual rotational and axial maneuvers for the removal of the pin. Delivered sterile, it can be used intraoperatively to protect temporarily the surgeon from cuts and pricks when placing multiple wires in a small area. ## M. INDICATIONS FOR USE: The wire protecting caps K-FIX® are indicated for use in the protection of protruding ends of wires. Examples of protruding wires include: Osteotomies, arthrodesis or fractures management in the foot or hand. Fixation of small bone fragments, in long bones or । small bones fractures - PREDICATE DEVICE: The K-FIX® is substantially equivalent to K-CAP-ES N. external protective caps from Westcon orthopedics (K914812), the Jurgan pin Ball® (K831072) from Jurgan Development and Mfg. # 0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: K FIX® (Newdeal), K-CAP-ES external protective caps (Westcon Orthopedics) and the Jurgan pin Ball® (Jurgan Development and Mfg.) are indicated for use in the protection of protuding ends of surgical wires. > Both of the K FIX®(Newdeal) and K-CAP-ES external protective caps (Westcon) are delivered sterile in a dispenser box of several units whereas the Jurgan pin Ball® (Jurgan Development and Mfg.) is included in a sterilizable polymer case (filled in any combination of models). > K FIX® (Newdeal), K-CAP-ES external protective caps ( (Westcon Orthopedics) and the Jurgan pin Ball" (Jurgan Development and Mfg.) are made of polymer. They are all external devices. > K FIX® (Newdeal), K-CAP-ES external protective caps (Westcon Orthopedics) and the Jurgan pin Ball® (Jurgan Development and Mfg) fit comparable ranges of wires diameters. > > 2 04 ನ್ನ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the text "Public Health Service" in a simple, sans-serif font. The text is black and appears to be against a white background. The words are stacked on a single line and are easily readable. Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. NOV 0 1 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Norman F. Estrin, Ph.D. Consultant to NewDeal SA Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854 Re: K022597 Trade/Device Name: K-Fix® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: July 28, 2002 Received: August 5, 2002 Dear Dr. Estrin: 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. Iisting 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 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. {3}------------------------------------------------ Page 2 - Norman F. Estrin, Ph.D. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html . Sincerely yours, 2. Mark A. Wilkinson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K02 2597 Page 1 of 1 Indications for Use : The wire protecting caps K-FIX® are indicated for use in the protection of protruding ends of wires. Examples of protruding wires include : -Osteotomies, arthrodesis or fractures management in the foot or hand. -Fixation of small bone fragments, in long bones or small bones fractures. Mark A. Millerson 17 Sisti. eral. Restorative 510(k) Number _ (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) イ Prescription Use OR Over -the-counter Use (Per 21 CFR 801.109) (Optional format 1-2-96) રુપર : ઉપદ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K022597](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K022597) **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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