The Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used for posterior non-cervical screw fixation in pediatric patients, the Rexious System, Statera™ Spinal Fixation System, and Statera-MTM System are indicated as an adjunct to fusion to treat: adolescent idiopathic scoliosis, progressive spinal deformities (i.e., scolosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, spondylolisthesis, spondylolysis, pseudarthrosis, failed prior fusion, and fracture caused by tumor and/or trauma in pediatric patients. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

When used as an anterolateral thoracolumbar system, the Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended for anterolateral screw (with staples) fixation for the following indications: degenerative discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

Device Description

The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, set screws, connectors, hooks, washers, staples, and transverse (cross) linking mechanisms.

The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

AI/ML Overview

This document describes the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System, which are spinal fixation systems. However, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study for AI/software devices.

Instead, this is a 510(k) summary for a medical device (spinal hardware), which focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than fulfilling specific performance acceptance criteria through clinical trials or software validation studies. The "performance data" referred to is primarily mechanical testing of the physical implants, comparing them to the predicate device.

Therefore, many of the requested sections (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of device and submission.

Here's an analysis based on the provided text, while acknowledging its limitations for the requested AI/software-centric details:

1. Table of Acceptance Criteria and Reported Device Performance

For this spinal fixation system, "acceptance criteria" and "reported device performance" are primarily focused on mechanical integrity and equivalence to the predicate device, not on diagnostic accuracy or AI performance.

Acceptance Criteria (Implied for Substantial Equivalence via Mechanical Testing)	Reported Device Performance (Mechanical Testing)
Material Equivalence: Materials of construction meet established standards (ASTM F67, F136, F1295, F1537) for titanium/titanium alloy and Cobalt-Chromium-Molybdenum.	The implants are fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295, and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537.
Mechanical Performance Equivalence: Static and dynamic mechanical properties (compression bending, torsion) are equivalent to the predicate device per ASTM F1717.	Non-clinical testing was performed in accordance with ASTM F1717 for: - Static compression bending - Dynamic compression bending - Static Torsion These tests "demonstrate that the Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the legally marketed predicate devices."
Design and Functionality Equivalence: The device design (components, principle of operation) is substantially equivalent to the predicate device.	The subject device has "the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device." "There are no technological differences between the Subject device and its predicate devices."

Note: For the Rexious Spinal Fixation System (part of the submission), no performance testing was required because it is identical to a system already cleared under K222415.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not applicable in the context of clinical/AI test sets. For mechanical testing, the "sample size" would refer to the number of physical implants tested. This specific number is not provided in the document, but it would have followed the requirements of ASTM F1717 for mechanical samples.
Data Provenance: The data is from non-clinical bench testing of physical device components, performed to demonstrate mechanical equivalence. Country of origin is not specified, but it's typically internal lab testing or third-party accredited labs. It is not prospective or retrospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This submission does not involve ground truth established by medical experts for diagnostic or AI performance. The "ground truth" for mechanical testing is adherence to engineering standards and comparison to the predicate device's mechanical properties.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method in the context of expert consensus or diagnostic disagreements, as this is bench testing of physical hardware.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a hardware medical device, not an AI/software device intended to assist human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical spinal fixation system, not a standalone algorithm.

7. The Type of Ground Truth Used

Mechanical Performance Standards and Predicate Device Data: The "ground truth" for this device's performance demonstration is based on established ASTM mechanical testing standards (specifically ASTM F1717) and comparative data from the legally marketed predicate devices. The goal is to show that the subject device performs similarly to or better than the predicate device in these mechanical tests.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

Summary

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October 24, 2023

Image /page/0/Picture/1 description: The image shows 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.

K&J Consulting Corp. Jeena Mathai 4027 Runnymeade Drive Collegeville, Pennsylvania 19426

Re: K232586

Trade/Device Name: Rexious Spinal Fixation System, Statera™ Spinal Fixation System, Statera-M™ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: August 23, 2023 Received: August 25, 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,

Eileen
Digitally signed
by Eileen Cadel -S
Date: 2023.10.24
Cadel -S 14:34:37 -04'00'

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

for

Enclosure

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Indications for Use

510(k) Number (if known) K232586

Device Name

Rexious Spinal Fixation System, Statera™ Spinal Fixation System, Statera-M™ Spinal Fixation System

Indications for Use (Describe)

The Rexious Spinal Fixation System, Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion

(pseudarthrosis).

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

Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ 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:	August 23, 2023
Device Name:	Rexious Spinal Fixation SystemStatera™ Spinal Fixation SystemStatera-M™ Spinal Fixation System
Common Name:	Pedicle Screw Spinal Fixation System
ClassificationName:	Thoracolumbosacral Pedicle Screw SystemSpinal Intervertebral Body Fixation OrthosisSpinal Interlaminal Fixation Orthosis
ClassificationNumber:	21 CFR 888.307021 CFR 888.306021 CFR 888.3050
Product Code/Classification:	NKB, KWP, KWQ, class II
DeviceDescription:	The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are top-loading multiple component, posterior spinalfixation systems which consist of pedicle screws, rods, set screws,connectors, hooks, washers, staples, and transverse (cross) linkingmechanisms.
	The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System will allow surgeons to build a spinal implant constructto stabilize and promote spinal fusion. The implant components aresupplied non-sterile, single use and fabricated from titanium or titaniumalloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and fromCobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537.Various sizes of these implants are available.
Indications forUse:	The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are intended to provide immobilization and stabilizationof spinal segments in skeletally mature patients as an adjunct to fusion in

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the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used for posterior non-cervical screw fixation in pediatric patients, the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are indicated as an adjunct to fusion to treat: adolescent idiopathic scoliosis, progressive spinal deformities (i.e., scoliosis, kyphosis, lordosis) including infantile and juvenile idiopathic scoliosis, or neuromuscular scoliosis, and congenital scoliosis, spondylolisthesis, spondylolysis, pseudarthrosis, failed prior fusion, and fracture caused by tumor and/or trauma in pediatric patients.

Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

When used as an anterolateral thoracolumbar system, the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are intended for anterolateral screw (with staples) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

Performance Data: Non-clinical testing was performed to demonstrate that the subject Statera™ Spinal System, and Statera-M™ Spinal System are 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™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the legally marketed predicate devices.

For the remaining subject devices, submission is only transferring name of a system that has already been cleared under K222415. As those subject devices are identical to the predicate devices, no performance testing is required.

Predicate Device: Primary predicate: Dio Medical - Rexious Spinal Fixation System (K222415) Additional predicates: Globus Medical - Revere Stabilization System (K133350)

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Substantial The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the predicate device, Equivalence: the Dio Medical - Rexious Spinal Fixation System. The Subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. There are no technological differences between the Subject device and its predicate devices. Thus, the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the predicates.
The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-Conclusion: M™ Spinal System have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. Thus, the subject devices are substantially equivalent to the predicate devices.

Regulation Number and Section

N/A