Thorecon Rigid Fixation System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. A&E Medical Corporation % Sarah Pleaugh Regulatory Affairs Sr. Specialist RTI Surgical, Inc 375 River Park Circle Marquette, Michigan 49855 October 12, 2018 Re: K181607 Trade/Device Name: Thorecon™ Rigid Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ, HRS, HWC, GAQ Dated: June 15, 2018 Received: June 19, 2018 Dear Sarah Pleaugh: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Daniel S. Ramsey -S 2018.10.12 15:35:25 -04'00' For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K181607 Device Name Thorecon Rigid Fixation System #### Indications for Use (Describe) The Thorecon Rigid Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for a company called "A&E MEDICAL". The logo consists of a black circle with two white intertwined shapes resembling the letters "A" and "E" on the left side. To the right of the circle, the word "MEDICAL" is written in a simple, sans-serif font, with a small registered trademark symbol next to the "L". ## 510(k) Summary Prepared on: June 15, 2018 | 510(k) Owner/<br>Manufacturer: | A&E Medical Corporation<br>5206 Asbury Road, PO Box 758<br>Farmingdale, NJ 07727 USA | |---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact<br>Person/<br>Consultant: | Sarah Pleaugh, RAC<br>Sr. Specialist, Regulatory Affairs<br>RTI Surgical, Inc.<br>Telephone: 1(906)226-9909 x 5861<br>Fax: (386) 418-1627<br>Email: spleaugh@rtix.com | | Trade name: | Thorecon™ Rigid Fixation System | | Common<br>name: | Sternal Fixation System | | Classification: | Class II;<br>21 CFR 888.3010 (JDQ, Cerclage, Fixation)<br>21 CFR 888.3030 (HRS, Plate, Fixation, Bone)<br>21 CFR 888.3040 (HWC, Screw, Fixation, Bone)<br>21 CFR 878.4495 (GAQ, Suture, Nonabsorbable, Steel,<br>Monofilament and multifilament, Sterile) | | Panel: | Panel Code 87 | | Predicate: | K173579 Thorecon Fixation System | | Description: | The Thorecon Rigid Fixation System may be implanted via an open<br>or minimally invasive approach. Where additional stability is desired,<br>devices can be used with traditional monofilament wire or Sternal<br>Cable of similar material. | | | The Thorecon Rigid Fixation System includes plates (some with<br>integrated cable subassemblies) manufactured from 316L stainless<br>steel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mn<br>stainless steel (ASTM F1314). Non-implantable needles, used to<br>guide the cable around the sternum, are manufactured from 420 or<br>Custom 470 stainless steel. | | | Thorecon devices are all single-use. The plates, complete with the<br>necessary screws and instruments (torque driver and<br>tensioner/cutter) required for completion of the surgery, are provided<br>sterile in a disposable kit. Sterile instruments and screw multi-packs<br>and a non-sterile cable/ plate cutter instrument are also available as<br>replacements and for use during emergent re-entry, if necessary.<br>The devices should be implanted using only the manual surgical<br>instruments designed specifically for the implants in the system. | | Indications for Use: | The Thorecon Rigid Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality. | | Purpose of Submission:<br>Summary of Technological Characteristics: | To obtain clearance of modifications to the Thorecon Rigid Fixation System, including the addition of MR Conditional Safety Labeling.<br>The subject devices have the same technological characteristics as the predicate K173579, including:<br>intended use/ indications for use and contraindications materials (metallic, stainless steel) principles of operation and fundamental technology (plates, pre-assembled cerclage(s) and/or screws for fracture fixation) instrumentation (e.g. torque driver, cable tensioner, cutters) surgical technique method (sizing, cable insertion, approximation, tensioning, screw placement, final locking, removal of excess cerclage, closure; emergent re-entry available if necessary) sterility (gamma irradiation) and packaging (double sterile barrier) bacterial endotoxin evaluation and limit (20 EU/device) substantially equivalent mechanical performance The modifications in labeling and design are supported by non-clinical testing listed below. | | Discussion of Supporting Non-Clinical Testing: | The following nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable.<br>Mechanical Performance Worst-Case Construct Assessment Assessment of previously completed testing Cerclage Dynamic Tension Testing MR Safety Evaluation following standards listed below: ASTM F2052-15, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment" ASTM F2213-17, "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment" | | | ASTM F2182-11a, “Standard Test Method for Measurement of<br>Radio Frequency Induced Heating Near Passive Implants<br>During Magnetic Resonance Imaging” ASTM F2119-07 (Reapproved 2013), “Standard Test Method<br>for Evaluation of MR Image Artifacts from Passive Implants” | | Conclusion: | The subject Thorecon Rigid Fixation System was shown to be<br>substantially equivalent to the predicate system. The devices are<br>determined to be MR Conditional based on the results of testing<br>completed according to FDA Guidance document "Establishing<br>Safety and Compatibility of Passive Implants in the Magnetic<br>Resonance (MR) Environment", December 11, 2014. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for A&E Medical. The logo consists of a black oval shape with the letters "A&E" in white inside the oval. To the right of the oval is the word "MEDICAL" in black, sans-serif font, with a registered trademark symbol next to it. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for A&E Medical. The logo consists of a black oval shape with two white intertwined letters, "A" and "E", on the left side. To the right of the oval is the word "MEDICAL" in black, sans-serif font, with a small registered trademark symbol next to it.