Velofix™ SA Cervical Cage

{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. November 22, 2017 U&I Corporation Jee-Ae Bang RA Assistant Manager 20. Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do 11781 Korea Re: K172424 Trade/Device Name: Velofix™ SA Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: October 18, 2017 Received: October 20, 2017 Dear Jee-Ae Bang: 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172424 Device Name Velofix™ SA Cervical Cage #### Indications for Use (Describe) The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # 510(k) Summary | Manufacturer: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>11781, Korea, | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>11781, Korea, | | Sponsor Contact: | Jee-Ae Bang, Regulatory Affairs Assistant Manager<br>+82 31 860 6846<br>bbangzhi@youic.com | | Date Prepared: | October 18, 2017 | | Device Name: | Trade Name: Velofix™TM SA Cervical Cage | | Classification Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical<br>, per 21 CFR 888.3080 | | Common Name: | Intervertebral Body Fusion Device, IBF Device | | Product Code: | OVE | | Primary Predicate: | AVS® Anchor-C Cervical Cage System (K102606) | | Additional Predicates: | Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage (K122872)<br>BAK/C Anterior Cervical Interbody Fusion System<br>(K143297)<br>Synthes Zero-P (K072981)<br>Cervical Stand Alone System (K132999, K161280) | # Description of Device: The Velofix™ SA Cervical Cage consists of cages, screws, locking plate and set screw. The cages are available in various heights, width and have only 7° lordotic angle with an open architecture to accept packing of autograft or autogenous bone graft, while the medical grade titanium alloy screws have various diameters and length for fixing the cages. The locking plate, made of radiolucent PEEK and titanium alloy, is to prevent screw loosening. The medical grade titanium alloy set screw is intended for fixation of the locking plate. The Velofix™ SA Cervical Cage has two types: - 1) The spacer which is made of radiolucent PEEK spacer (polymer polyether- {4}------------------------------------------------ ether-ketone, ASTM F2026) with the tantalum markers (ASTM F560). - 2) The spacer which is a combination of radiolucent PEEK spacer with the x-ray markers and medical grade titanium alloy plate (Ti6AI4V ELI, ASTM F136). The Velofix™ SA Cervical Cage is implanted as a single device via an anterior approach by using the instruments manufactured from stainless steel materials that conform to ASTM F899. ### Indications For Use: The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment. ## Substantial Equivalence: The Velofix 110 SA Cervical Cage is substantially equivalent to AVS Anchor-C Cervical Cage System (K102606), Galaxy ACIF Cage (K122872), BAK/C Anterior Cervical Interbody Fusion System (K143297), Synthes Zero-P (K072981), and Cervical Stand Alone System (K132999, K161280) in design, material, mechanical performance, function and intended use. The primary predicate device is the AVS® Anchor-C Cervical Cage System, and the others are additional predicate device. The mechanical performance of Velofix™ SA Cervical Cage met the acceptance criteria which have been established from the predicate devices. 1. Comparison Technological Characteristics The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities; - The similar indications for use - Similar design features ● - Incorporate the same or similar materials - The equivalent mechanical performance {5}------------------------------------------------ # 2. Performance Testing The Velofix™ SA Cervical Cage was tested in a non clinical setting (bench testing) to assess that to no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the Velofix™ SA Cervical Cage is substantially equivalent to the predicate devices. The following tests were performed: - 1) Velofix™ SA Cervical Cage - (1) Static compression test according to ASTM F2077 - (2) Static torsion test according to ASTM F2077 - (3) Dynamic compression test according to ASTM F2077 - (4) Dynamic torsion test according to ASTM F2077 - (5) Subsidence test according to ASTM F2267 - (6) Axial pullout test according to ASTM F543 - (7) Torsional properties test according to ASTM F543 - (8) Driving torque test according to ASTM F543 - 3. Conclusion The data and information provided in this submission support the conclusion that the Velofix'" SA Cervical Cage is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.