← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K032167 # BIO-INTRAFIX TIBIAL SCREW AND SHEATH (K032167) _Mitek Worldwide · HWC · Oct 15, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K032167 ## Device Facts - **Applicant:** Mitek Worldwide - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Oct 15, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Bio-INTRAFIX Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction. ## Device Story Bio-INTRAFIX is a two-part absorbable fixation system consisting of a tapered screw and a sheath. Used by surgeons during cruciate ligament reconstruction to secure soft tissue grafts to bone. The device functions as a mechanical fastener to provide stability during the healing process. It is an implantable orthopedic device. ## Clinical Evidence No clinical data; substantial equivalence determination based on device description and conformance to consensus and voluntary standards. ## Technological Characteristics Absorbable fixation implant; two-part system comprising a tapered screw and sheath; designed for soft tissue graft fixation in orthopedic surgery. ## 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 - IntraFIX ([K983560](/device/K983560.md)) - Biocryl Interference Screws ([K013572](/device/K013572.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}------------------------------------------------ # OCT 1 5 2003 Koz2167 pye'f2 ## 510(k) Summary of Substantial Equivalence Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Worldwide is required to submit with this Premarket Notification either an "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Mitek Worldwide chooses to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... " #### 1. MANUFACTURER: Mitek Worldwide A division of Ethicon A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062 Contract: Karen K. Sylvia, Manager, RA Date Prepared: 15 July 2003 #### 2. DEVICE: | Trade name: | Bio-INTRAFIX Tibial Tapered Screws and Sheaths | |----------------------|------------------------------------------------| | Classification Name: | Fastener, Fixation, Biodegradable Soft Tissue | | Product Code: | MAI | | Classification: | 888.3040 | | Common Name: | Orthopedic Screw, Fixation Device | #### 3. PREDICATE DEVICE: The predicate devices used to determine substantial equivalence for the Mitek's Bio-INTRAFIX Tibial Screw and Sheaths are IntraFIX (K983560) and Biocryl Interference Screws (K013572) currently marketed by Mitek Worldwide, Norwood, MA 02062. #### 4. DEVICE DESCRIPTION: The Mitek Bio-INTRAFIX Tibial Screw and Sheath is an absorbable fixation implant for the repair of soft tissue grafts during ligament reconstruction. Bio-INTRAFIX is a two-part system designed to fixate soft tissue to bone for ligament reconstruction. #### 5. INTENDED USE: The Bio-INTRAFIX Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction. {1}------------------------------------------------ page 2 of 2 ### 6. Safety and Performance: The determination of substantial equivalence for this device was based on a detailed device description, conformance to consensus standards and voluntary standards. Based on the indications for use, technological characteristics, and comparison to predicate devices, the Mitek Bio-INTRAFIX Tibial Screw and Sheath have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## OCT 1 5 2003 Ms. Karen K. Sylvia Regulatory Affairs Manager Mitek Worldwide 249 Vanderbilt Avenue Norwood, MA 02062 Re: K032167 Trade/Device Name: Bio-INTRAFIX Tibial Tapered Screw and Sheath Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 15, 2003 Received: July 21, 2003 Dear Ms. Sylvia: 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 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 - Ms. Karen K. Sylvia 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 (301) 594-4639. 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 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, Mark N. Millerson 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}------------------------------------------------ 510(k) Number (if known) Device Name Bio-INTRAFIX Tibial Screw and Sheath Indications for Use The Bio-INTRAFIX Tibial Tapered Screw and Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction. (Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE) for Mark N. Millman (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K032167 Prescription Use ( (Per 21 CFR § 801/109) OR Over-the-Counter Use No (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K032167](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K032167) **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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