Statera-C™ Spinal System

{0}------------------------------------------------ November 27, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. K&J Consulting Corp. % Jeena Mathai President Eerkie Corporation 4027 Runnymeade Drive Collegeville, Pennsylvania 19426 ### Re: K233332 Trade/Device Name: Statera-CTM Spinal System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: September 28, 2023 Received: September 29, 2023 ### Dear Jeena Mathai: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/6 description: The image contains the text "Colin O'neill -S" in a simple, sans-serif font. The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. The text is black, and the background is white. Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233332 Device Name Statera-CTM Spinal System #### Indications for Use (Describe) The Statera-CM Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. It is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Statera-C™ Spinal System may be connected to the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-MTM Spinal System using corresponding connectors and/or transition rods. Type of Use (Select one or both, as applicable) | <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </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}------------------------------------------------ # 510(k) SUMMARY # K&J Consulting Statera-C™ Spinal System | Submitter: | K&J Consulting Corp.<br>2260 Glenview Dr, Lansdale PA 19446<br>Phone: (716) 465-5551<br>Email: kj.eng.consulting.services@gmail.com | |---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Jeena Mathai<br>Eerkie Corporation<br>4027 Runnymeade Dr, Collegeville, PA 19426<br>Phone: (760) 521-5870<br>Email: mgsharemg@gmail.com | | Date Prepared: | November 15, 2023 | | Device Name: | Statera-C™ Spinal System | | Common Name: | Posterior Cervical Screw System<br>Spinal Interlaminal Fixation System | | Classification<br>Name: | Posterior Cervical Screw System<br>Spinal Interlaminal fixation orthosis | | Classification<br>Number:<br>Product Code/<br>Classification: | 21 CFR 888.3075<br>21 CFR 888.3050<br>NKG, KWP, Class II | | Description: | The Statera-C™ Spinal System is a posterior cervico-thoracic fixation<br>system intended to provide stabilization to promote fusion of the cervical<br>spine and upper thoracic spine. The Statera-C™ Spinal System contains<br>rods, polyaxial screws, hooks, set screws, connectors and cross connectors<br>that are made from Titanium alloy and Cobalt Chrome alloy and are<br>available in multiple shapes and sizes. Connecting components can be<br>locked to the rod in various configurations to accommodate individual<br>patient anatomy. | | Indications for<br>Use: | The Statera-C™ Spinal System is intended to provide immobilization and<br>stabilization of spinal segments as an adjunct to fusion for the following:<br>acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic<br>spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations;<br>instability or deformity; failed previous fusions (e.g. pseudoarthrosis);<br>tumors involving the cervical/thoracic spine; and degenerative disease,<br>including intractable radiculopathy and/or myelopathy, neck and/or arm<br>pain of discogenic origin as confirmed by radiographic studies, and<br>degenerative disease of the facets with instability. It is also intended to<br>restore the integrity of the spinal column even in the absence of fusion for | {4}------------------------------------------------ a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Statera-C™ Spinal System may be connected to the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System using corresponding connectors and/or transition rods. Performance Data: Non-clinical testing was performed to demonstrate that the subject Statera-C™ Spinal System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F1717: - Static compression bending - Dynamic compression bending - Static Torsion The nonclinical tests demonstrate that the Statera-C™ Spinal System is substantially equivalent to the legally marketed predicate devices. - Primary predicate: Globus Medical ELLIPSE® and PROTEX® CT Spinal Predicate Device: Systems (K150552) Reference Device: K&J Consulting – Fortis And Hana Anterior Cervical Plate System, Rex Anterior Cervical Plate System, Balteum™ & Balteum-One™ Lumbar Plate System, And Osprey™ Anterior Cervical Plate System (K231460) - Substantial The Statera-C™ Spinal System is identical to the predicate device and is as Equivalence: safe and effective as the Globus Medical – ELLIPSE® and PROTEX® CT Spinal Systems. The Subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its There are no technological differences between predicate device. the Subject device and its predicate devices. Thus, the Statera-C™ Spinal System is substantially equivalent to the predicate. The Statera-C™ Spinal System have the same intended uses and Conclusion: similar indications, technological characteristics, and principles of operation as the predicate device. Thus, the subject device is substantially equivalent to the predicate devices.