← Product Code [HWC](/productcode/HWC) · K060393 # INION HEXALON BIODEGRADABLE ACL/PCL SCREW (K060393) _Inion , Ltd. · HWC · Mar 13, 2006 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K060393 ## Device Facts - **Applicant:** Inion , Ltd. - **Product Code:** [HWC](/productcode/HWC.md) - **Decision Date:** Mar 13, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissuc grafts. ## Device Story Inion Hexalon™ Biodegradable ACL/PCL Screw is a bone fixation fastener used in orthopedic surgery for anterior and posterior cruciate ligament (ACL/PCL) reconstruction. The device provides interference fixation for bone-tendon-bone or soft tissue grafts. It is a line extension of the previously cleared Inion Hexalon™ system (K021280), maintaining identical copolymer composition, manufacturing, and sterilization methods. The screw is implanted by a surgeon in an operating room setting to secure grafts within the bone. By providing stable fixation during the healing process, the device facilitates ligament reconstruction. The biodegradable nature of the material eliminates the need for secondary removal surgery. ## Clinical Evidence No clinical data provided; substantial equivalence is based on design, material, and performance specifications identical to the predicate device. ## Technological Characteristics Biodegradable bone fixation screw. Material: Copolymer composition identical to predicate. Sterilization: Identical to predicate. Form factor: Threaded bone fixation fastener. Regulatory Class II, Product Code HWC. ## 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 - Inion Hexalon™ Biodegradable ACL/PCL Screw ([K021280](/device/K021280.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}------------------------------------------------ Kobo193 Page 1 of 2 MAR 1 3 2006 Image /page/0/Picture/2 description: The image shows a close-up of a logo with the word "INION" in large, bold white letters against a black background. Below the main word, the phrase "Intelligent Solution" is written in a smaller, sans-serif font, also in white. The overall design is simple and high-contrast, emphasizing the brand name. #### SPECIAL 510(k) SUMMARY for the line extension of INION Hexalon ™ Biodegradable ACL/PCL Screw (K021280) #### MANUFACTURER Inion Ltd., Lääkärinkatu 2, FIN-33520 Tampere, FINLAND #### Contact Person Hanna Marttila, Regulatory Affairs Director Lääkärinkatu 2, FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 691 hanna.marttila@inion.com #### DEVICE NAME Trade name: Inion Hexalon™ Biodegradable ACL/PCL Screw Common/Usual Name: Biodegradable Interference Screw Classification Name: Bone Fixation Screw #### ESTABLISHMENT REGISTRATION NUMBER 9710629 #### DEVICE CLASSIFICATION AND PRODUCT CODE Classification panel: Orthopedic Regulation number: 21 CFR 888.3040 Regulation name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC PREDICATE DEVICE Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280) ## CONFORMANCE WITH PERFORMANCE STANDARDS No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application. #### THE REASON FOR SCPECIAL 510(k) New screws to be added to Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280). {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with the word "INION" in large, bold white letters against a black background. Below "INION" is the phrase "Intelligent Solution" in a smaller, white sans-serif font. The overall design is simple and high-contrast, emphasizing the brand name. # Page 2 of 2 ### DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION Inion Hexalon™ Biodegradable ACL/PCL screws are intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts. The new screws are identical with the other implants in the previously 510(k) cleared Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280) in terms of copolymer composition, colour additive, intended use and indications for use as described in the device labelling. manufacturing method and sterilization method. ### EQUIVALENCE TO MARKETED PRODUCTS Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, dogradation profile and substantially equivalent with the predicate device Inion Hexalon™ Biodegradable ACL/PCT. screw (K021280). The new Inion Hexalon™ Biodegradable ACL/PCL screws are substantially equivalent (1) predicate Class II devices used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts, because the differences between the new Inion Hexalon™ Biodegradable ACL/PCL screws and the predicate device do not raise new questions of safety and effectiveness. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three wavy lines extending from its head. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 3 2006 Inion Limited c/o Ms. Hanna Marttila Regulatory Affairs Director Laakarinkatu 2 Fin-33520 Tampere Finland Re: K060393 Trade/Device Name: Inion Hexalon™ Biodegradable ACL/PCL Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 13, 2006 Received: February 15, 2006 Dear Ms. Marttila: 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 {3}------------------------------------------------ Page 2 – Ms. Hanna Marttila 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 _ prarketed 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Helut Zemer Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number: K060393 Device Name: Inion Hexalon™ Biodegradable ACL/PCL Screw #### Indications: The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissuc grafts. #### Contraindications: The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is contraindicated in casc of : 1. Insufficient quality or quantity of bone for interference screw attachment 2. Active or potential infections 3. Patient conditions including limited blood supply, chronic disease which causes insufficient quality of bone, and where patient cooperation cannot be guaranteed (e.g. alcoholism, drug abuse) Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use No (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) Hichard Lunn Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number K060393 --- **Source:** [https://fda-staging.innolitics.com/device/K060393](https://fda-staging.innolitics.com/device/K060393) **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