The Statera-C™ 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-M™ Spinal System using corresponding connectors and/or transition rods.

Device Description

The Statera-C™ Spinal System is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and upper thoracic spine. The Statera-C™ Spinal System contains rods, polyaxial screws, hooks, set screws, connectors and cross connectors that are made from Titanium alloy and Cobalt Chrome alloy and are available in multiple shapes and sizes. Connecting components can be locked to the rod in various configurations to accommodate individual patient anatomy.

AI/ML Overview

The provided text is related to an FDA 510(k) clearance for a spinal system and does not contain any information about an AI/ML-driven medical device. Therefore, I cannot extract the requested details about acceptance criteria, study performance, sample sizes, ground truth establishment, or expert involvement for an AI medical device from this document.

The document describes the Statera-C™ Spinal System as a physical medical device (rods, screws, hooks, etc.) used for spinal stabilization and fusion, with its performance demonstrated through non-clinical testing according to ASTM F1717 standards (static compression bending, dynamic compression bending, static torsion).

To address your request, information about an AI/ML medical device's performance study would need to be provided.

Summary

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November 27, 2023

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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).

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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

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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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

K&J Consulting Statera-C™ Spinal System

Submitter:	K&J Consulting Corp.2260 Glenview Dr, Lansdale PA 19446Phone: (716) 465-5551Email: kj.eng.consulting.services@gmail.com
Official Contact	Jeena MathaiEerkie Corporation4027 Runnymeade Dr, Collegeville, PA 19426Phone: (760) 521-5870Email: mgsharemg@gmail.com
Date Prepared:	November 15, 2023
Device Name:	Statera-C™ Spinal System
Common Name:	Posterior Cervical Screw SystemSpinal Interlaminal Fixation System
ClassificationName:	Posterior Cervical Screw SystemSpinal Interlaminal fixation orthosis
ClassificationNumber:Product Code/Classification:	21 CFR 888.307521 CFR 888.3050NKG, KWP, Class II
Description:	The Statera-C™ Spinal System is a posterior cervico-thoracic fixationsystem intended to provide stabilization to promote fusion of the cervicalspine and upper thoracic spine. The Statera-C™ Spinal System containsrods, polyaxial screws, hooks, set screws, connectors and cross connectorsthat are made from Titanium alloy and Cobalt Chrome alloy and areavailable in multiple shapes and sizes. Connecting components can belocked to the rod in various configurations to accommodate individualpatient anatomy.
Indications forUse:	The Statera-C™ Spinal System is intended to provide immobilization andstabilization of spinal segments as an adjunct to fusion for the following:acute and chronic instabilities of the cervical spine (C1-C7) and the thoracicspine (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 armpain of discogenic origin as confirmed by radiographic studies, anddegenerative disease of the facets with instability. It is also intended torestore the integrity of the spinal column even in the absence of fusion for

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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.

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.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are 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.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.