The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

Device Description

The CervAlign Anterior Cervical Plate System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending, and axial rotation with strength and stiffness in the cervical spine (C2-C7). The system includes implants of various sizes of screws and plates to accommodate varying patient anatomies. The plates have integrated cover-style locking mechanisms that actuate to cover each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V ELI (ASTM F136). The implants are supplied with instrumentation necessary to facilitate the insertion and removal. The implants and instruments are provided non-sterile and must be sterilized before use. Sterilization cases and trays are provided to facilitate proper sterilization and storage.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance
Mechanical Testing:
Locking Mechanism Retention	Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use.
ASTM F1717-18 static and dynamic compression bending	No specific numerical performance provided in this summary, but the document states: "Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use." (This test was included in the previously cleared K183060).
ASTM F1717-18 static torsion	No specific numerical performance provided in this summary, but the document states: "Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use." (This test was included in the previously cleared K183060).
MR Safety Evaluation:
Magnetically Induced Displacement Force (ASTM F2052-15)	The devices are determined to be MR Conditional.
Magnetically Induced Torque (ASTM F2213-17)	The devices are determined to be MR Conditional.
Radio Frequency Induced Heating (ASTM F2182-19e2)	The devices are determined to be MR Conditional.
MR Image Artifacts (ASTM F2119-07 (Reapproved 2013))	The devices are determined to be MR Conditional.
Marking for Safety in the MR Environment (ASTM F2503-20)	The devices are determined to be MR Conditional.
Other Testing:
Packaging and Sterilization	Testing and evaluations were performed.
Biological Safety (ISO 10993-1)	Evaluations were performed.

Note: The summary specifically states for the mechanical tests (ASTM F1717-18 series) and MR safety evaluations that there was "no impact to the following non-clinical performance data that was included in cleared submission K183060. This testing is not included in the subject submission." This indicates that these tests were previously conducted for the predicate device and were considered still valid for the current submission due to the device's similarity. The "Locking Mechanism Retention" test is explicitly mentioned as being part of the current submission.

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

The provided document does not mention a "test set" in the context of clinical studies for this device. The submission is based entirely on non-clinical performance data and demonstration of substantial equivalence to a predicate device. Therefore:

Sample Size for Test Set: Not applicable, as no human clinical test set was used.
Data Provenance: Not applicable for clinical data. For non-clinical data, the provenance would be from laboratory testing. The country of origin for such testing is not specified. The testing described is likely prospective in a laboratory setting.

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

Not applicable, as no human clinical test set or ground truth established by experts for such a set was used for this submission. The device equivalence is based on engineering and materials testing, not diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable, as no human clinical test set necessitating adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done, as this is a physical implant device and not a diagnostic AI/CAD system. The submission relies on non-clinical performance testing and substantial equivalence to a predicate.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable, as this is a physical medical device (spinal implant) and not an algorithm or AI system.

7. Type of Ground Truth Used

The concept of "ground truth" (e.g., pathology, outcomes data) as typically understood for diagnostic or AI devices is not directly applicable here. For this device, the "truth" is established by:

Engineering Standards: Adherence to established ASTM (American Society for Testing and Materials) standards for mechanical properties and MR compatibility.
Biological Safety Standards: Compliance with ISO 10993-1 for biocompatibility.
Predicate Device Performance: The primary "ground truth" for substantial equivalence is the known safe and effective performance of the predicate device (CervAlign Anterior Cervical Plate System K183060). The new submission aims to demonstrate that its characteristics and performance are equivalent or better than this established device.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable, as this is not an AI/ML device requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is in blue text. The seal features an emblem with a staff and serpent, symbolizing healing and medicine.

Pioneer Surgical Technology, Inc. Jaclyn Holli Sr. Specialist, Regulatory Affairs 375 River Park Circle Marquette, Michigan 49855

Re: K211408

Trade/Device Name: Cerv Align ® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: May 5, 2021 Received: May 6, 2021

Dear Jaclyn Holli:

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. 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 located 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.

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

June 23, 2021

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801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K211408

Device Name CervAlign® Anterior Cervical Plate System

Indications for Use (Describe)

The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

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

As required by 21 CFR 807.92

Company:	Pioneer Surgical Technology, Inc.375 River Park CircleMarquette, MI 49855, USAPhone: +1-906-226-9909Fax: +1-906-226-4443
Submitter/Contact:	Jaclyn HolliSr. Specialist, Regulatory AffairsPioneer Surgical Technology, Inc.jholli@rtix.com
Date Prepared	May 5, 2021
Proprietary Name	CervAlign® Anterior Cervical Plate System
Common Name	Anterior Cervical Plate System
Classification	Class II; 21 CFR 888.3060 (Product Code KWQ - Appliance, Fixation,Spinal Intervertebral Body) Spinal Intervertebral Body Fixation Orthosis
Panel	Orthopedic Device Panel
Predicate Device	CervAlign Anterior Cervical Plate System (K183060 cleared January 17,2019) - Pioneer Surgical Technology, Inc.
Device Description	The CervAlign Anterior Cervical Plate System is designed to promotecervical fusion by providing temporary resistance to flexion, extension,lateral bending, and axial rotation with strength and stiffness in thecervical spine (C2-C7). The system includes implants of various sizes ofscrews and plates to accommodate varying patient anatomies. The plateshave integrated cover-style locking mechanisms that actuate to covereach screw. Implants are manufactured from titanium alloy, Ti-6Al-4VELI (ASTM F136). The implants are supplied with instrumentationnecessary to facilitate the insertion and removal.The implants and instruments are provided non-sterile and must besterilized before use. Sterilization cases and trays are provided tofacilitate proper sterilization and storage.
Indications for Use	The CervAlign Anterior Cervical Plate System is intended for anteriorcervical fixation (C2-C7) for the following conditions: degenerative discdisease (DDD) defined as neck pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies,spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis,deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),tumor, pseudarthrosis, and failed previous fusion.
Non-clinicalPerformance Data	Performance testing showed that the mechanical strength of the subjectsystem is equivalent to or better than predicate devices and is thereforesufficient for the intended use.Mechanical Testing:Locking Mechanism Retention●There is no impact to the following non-clinical performance data thatwas included in cleared submission K183060. This testing is not includedin the subject submission:
	Mechanical Testing ASTM F1717-18 static and dynamic compression bending ASTM F1717-18 static torsion MR Safety Evaluation determined the devices are MR Conditional via the following standards: ASTM F2052-15, “Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment” ASTM F2213-17, “Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment” ASTM F2182-19e2, “Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging” ASTM F2119-07 (Reapproved 2013), “Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants” ASTM F2503-20 “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment” Packaging and sterilization testing and evaluations ISO 10993-1 Biological safety evaluation
Clinical Performance Data	No clinical performance data was required for a determination of substantial equivalence.
Summary of Technological Characteristics:	The subject system has the same or similar fundamental technology (technological characteristics, indications for use, material, principles of operation, overall implant geometry and size options, and anatomical location of use) as the predicate.
Substantial Equivalence	The supporting evidence in this submission is sufficient to justify the substantial equivalence of the subject CervAlign Anterior Cervical Plate System as compared to the predicate device referenced.

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Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.