LOSPA IS ACP System

{0}------------------------------------------------ Image /page/0/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 an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a flowing ribbon representing the snakes. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 5, 2017 Corentec Co., Ltd J.S. Daniel Senior Manager/Engineer - RA & QA 8f Chungho Tower, 483, Gangnam-daero Seocho Gu Seoul, South Korea 06541 Re: K161641 Trade/Device Name: LOSPA IS ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 11, 2016 Received: November 15, 2016 Dear Mr. Daniel: 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 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 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, # Lori A. Wiggins -S for 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) K161641 Device Name LOSPA IS ACP System Indications for Use (Describe) LOSPA IS ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indication: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2) Trauma (including fractures) 3) Tumors 4) Deformities or curvatures (including kyphosis, lordosis or scoliosis) 5) Pseudoarthrosis 6) Failed previous fusion. | 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. 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}------------------------------------------------ # 510(K) SUMMARY # Corentec Co., Ltd. # LOSPA IS ACP System 5th Jan., 2017 # ADMINISTRATIVE INFORMATION | Manufacturer | Corentec Co., Ltd. | |------------------|--------------------------------------------------| | | 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu | | | Cheonan-si, Chungchongnam-do, 06541, South Korea | | | Telephone: +82-41-585-7114 | | | Fax: +82-41-585-7113 | | Official Contact | J.S. Daniel | | | Associate Director – Global RA/QA | | | Corentec Co., Ltd | | | 8F Chungho Tower, 483, Gangnam-daero, | | | Seocho Gu, Seoul, Korea 31056 | | | Ph: +82 70 4393 3819 | | | Fax: +82 2 3445 5467 | | | Email: jsdaniel@corentec.com | # DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name: | LOSPA IS ACP System | |-----------------------------|---------------------------------------| | Common Name: | Intervertebral body fixation orthosis | | Classification Regulations: | 21 CFR 888.3060 | | Regulatory Class: | Class II | | Product Codes: | KWQ | | Classification Panel: | Orthopedic Products Panel | | Reviewing Branch: | Anterior Spine Devices Branch | {4}------------------------------------------------ ## INDICATIONS FOR USE ### LOSPA IS ACP System LOSPA IS ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indication: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - 2) Trauma (including fractures) - 3) Tumors - 4) Deformities or curvatures (including kyphosis, lordosis or scoliosis) - 5) Pseudoarthrosis - 6) Failed previous fusion. ### DEVICE DESCRIPTION #### LOSPA IS ACP System LOSPA IS ACP System is composed of a bone plate (a locking mechanism is preassembled to plates) and screws. The design features are common with the design features of the predicate devices. Plates have a Low profile with windows. A locking system between plate and screw which also prevents back out. Plates attach to the anterior cervical spine with a minimum of four screws per plate. The plate ranges in length to accommodate one, two, three, and four level procedures. Available in multitude of similar sizes to suit the individual pathology and anatomic condition of the patient. Screws are available as Self-tapping & Self-drilling types. Fixation can be Fixed, Variable or Hybrid types. Both the plate and screws are made of Titanium alloy as described in ASTM F136, ISO 5832-3. Implant is available as non-sterile & sterile. LOSPA IS ACP System is available in - . Width of 18 mm & Thickness of 1.9 and 2.3 mm and Levels 1 to 4 with height ranging from 20 to 110 mm. - Screw has Core Dia. 2.5 & Outer Dia. 4.0, 4.5 with length ranging from 12 to 18mm. {5}------------------------------------------------ ### LOSPA IS SPINAL SYSTEM INSTRUMENTATION LOSPA IS Spinal Fixation System Instrumentation which includes instruments for subject devices ACP System consisting of set of accessories to be used with LOSPA IS ACP System. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons. The parts of the instruments are made of stainless steel and polymers which are biocompatible and used in medical industry. ### SUBSTANTIAL EQUIVALENCE The LOSPA IS ACP System is similar to the 510(k) cleared devices as mentioned below with respect to indications, design, operating principles and material. | LOSPA IS<br>Spinal Systems | Predicate<br>Category | Manufacturer | Trade Name | 510(k) | |----------------------------|-----------------------|----------------------------------------|------------------------|---------| | ACP System | Primary | Medtronic Sofamor<br>Danek USA | ATLANTIS<br>ACP System | K063100 | | | Additional | Howmedica Osteonics<br>Corp. (Stryker) | REFLEX ACP<br>System | K010115 | The LOSPA IS Spinal Systems consisting of Anterior Cervical Plate System components and all the predicate devices have same intended use and same indications for use. The LOSPA IS ACP System has a profile similar with primary predicate ATLANTIS ACP System [K063100] and additional predicate, REFLEX ACP System [K010115], with windows for graft. The overall design and dimensional specification of LOSPA IS ACP System is similar to its predicate devices. The design features of LOSPA IS Spinal Systems consisting LOSPA IS ACP System are common with of all the predicate devices as described in device description. At a high level LOSPA IS ACP System Devices have the following similarities to the predicate devices: - has the same intended use, ● - has similar indications for use, ● - uses similar operating principles, ● - incorporates similar basic designs & specifications, ● - incorporates same or similar materials, and ● - is supplied Non Sterile and/or Sterile {6}------------------------------------------------ ## PERFORMANCE DATA For LOSPA IS ACP System performance testing was carried out to demonstrate substantial equivalence. Testing of the subject devices consisted of static compression & tension bending, static torsion, dynamic compression, axial pullout/pushout and torque to failure and Pyrogen testing and included methods described in the standard ASTM F1717 & ASTM F543 & AAMI ST72. The results of this testing showed that the subject devices are expected to be as safe and as effective as the predicate devices. Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. ### STERILIZATION & PACKAGING Similar to the predicate devices, the LOSPA IS ACP System are packaged in pouch and supplied sterile and non sterile. The non sterile implants and all instruments used in the surgery must be sterilized by the end user, prior to use, as mentioned in the IFU. Steam sterilization validation for the subject non sterile devices was conducted as per, ISO 17665-1. For the sterile components, following to gamma sterilization, packaging was subjected to sterile barrier testing to validate a shelf life of 5 years as per ISO & ASTM standards confirms the stability and effectiveness of packaging of the sterilized product during the shelf-life, by evaluating changes by accelerated aging, as per ASTM F1980. Gamma sterilization validation for the subject sterile devices was conducted as per, ISO 11137-1 & ISO 11137-2. Additionally, for sterile components, Pyrogen testing as per AAMI ST72 was conducted. ### CONCLUSION Overall, the LOSPA IS ACP System is similar to the identified primary predicate device and additional predicates. Any differences in technological characteristic between the subject and primary predicate device and additional predicate do not raise new issues of safety or efficacy and has been adequately addressed in this premarket notification.