ACTIVE ANTERIOR CERVICAL PLATE SYSTEM by SANACOR

The Active "10 Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-11) with removal of the implants after the attainment of a solid fusion mass. The Active ™ Anterior Cervical Plate System is intended for use under the following indications:

· Degenerative disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Spondylolisthesis
· Trauma (i.e., fracture or dislocation)
· Spinal stenosis
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

• Tumor

• Pseudoarthrosis

· Failed previous fusion

Device Description

The Active " Anterior Cervical Plate System is a fixation system designed to allow for settling of the bone graft during fusion. Plates are provided in various lengths to accommodate fusions from 1 to 4 Ievels. Fixed and variable angle locking unicortical screws are provided in lengths of 12, 14, 16, and 18mm and diameters of 4mm and 4.5mm.

AI/ML Overview

The provided text describes the 510(k) summary for the "Active Anterior Cervical Plate System" (K073500), a medical device intended for spinal fixation. This submission focuses on establishing substantial equivalence to previously marketed predicate devices, primarily through mechanical performance testing and comparison of technological characteristics.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical performance attributes per ASTM F1717	Found to be substantially equivalent to those of predicate devices.

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

The document does not specify a separate "test set" in the context of clinical data or patient samples. The evaluation of this device is based on mechanical performance attributes per ASTM F1717. For such testing, the "sample size" would refer to the number of devices or components tested. This information is not provided in the given text.

Similarly, the data provenance (country of origin, retrospective/prospective) is not applicable as the study described is a mechanical engineering test, not a clinical study involving human subjects or their data.

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

This information is not applicable. The "ground truth" for mechanical testing is typically established by the specifications of the ASTM F1717 standard and the results of the physical tests themselves. It does not involve human expert consensus in the way clinical studies do.

4. Adjudication Method for the Test Set

This is not applicable for mechanical performance testing. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where human interpretation or consensus is required to establish ground truth or resolve discrepancies in evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

This information is not applicable. The submission describes a spinal fixation system, which is a physical implant, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily mechanical performance standards (ASTM F1717). The device's performance was compared to existing predicate devices based on these standards.

8. The Sample Size for the Training Set

This information is not applicable as the evaluation is based on mechanical performance testing, not a machine learning model that requires a "training set."

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

This is not applicable for the same reasons as #8.

Summary of the Study and Device Performance:

The study described for the Active Anterior Cervical Plate System is largely a technical and mechanical performance evaluation to demonstrate substantial equivalence to legally marketed predicate devices. The primary "study" involved:

Comparison of Technological Characteristics: The device's features (augmenting stability, segmented plate for screw translation, use of titanium alloys, compression application) were compared and found to be substantially equivalent to features present in various predicate devices.
Mechanical Testing per ASTM F1717: The device underwent mechanical performance testing according to the ASTM F1717 standard. The results of this testing demonstrated that its mechanical attributes were "substantially equivalent" to those of the predicate devices.

The FDA's review concluded that the device is substantially equivalent to predicate devices for its stated indications for use, primarily based on these comparative analyses and mechanical testing. No clinical studies with human participants, expert consensus for diagnosis, or AI performance evaluations are mentioned in this 510(k) summary.

Summary

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KO73500

510(k) Summary

JUL - 3 2008

Submitter: Sanacor LLC Contact Person: Mr. Michael D. Ensign Sanacor LLC 765 E 340 S Suite 204 American Fork, UT 84003 Telephone: (801) 756-6249 Fax: (801) 756-8286 Date Prepared: March 13, 2008 Trade Name: Active Anterior Cervical Plate System Classification: Class II Classification Name: Appliance, fixation, spinal intervertebral body Number: 21 CFR 888.3060 Product Code: KWO Predicate Device(s): The subject device is substantially equivalent to the following systems which are currently marketed and distributed in the US: PreView Anterior Cervical Plate (K062371), Sanacor CSLP (K030866), Synthes DOC VCSS (K982443), DePuy Spine C-Jaws Cervical Compression Mini Frame (K062181) Medicrea Technologies OSStaple Staple System (K061385), BioMedical Enterprises, Inc. Pioneer Anterior Cervical Plate System (K043066) Pioneer Surgical Technology Ant-Cer Dynamic Anterior Cervical Plate System (K024326) Spinal Concepts. Inc. Synthes Vectra-T System (K051665), Synthes Spine C3 Anterior Cervical Plate System (K012881), Spine Vision

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K073500
Page 2 of 2

Device Description: The Active " Anterior Cervical Plate System is a fixation system designed to allow for settling of the bone graft during fusion. Plates are provided in various lengths to accommodate fusions from 1 to 4 Ievels. Fixed and variable angle locking unicortical screws are provided in lengths of 12, 14, 16, and 18mm and diameters of 4mm and 4.5mm.

The Active™ Anterior Cervical Plate System is intended for the treatment Intended Use: of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The Active "10 Anterior Cervical Plate System is intended for use under the following indications:

· Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Spondylolisthesis
· Trauma (i.e., fracture or dislocation)
· Spinal stenosis

· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

Tumor
· Pseudoarthrosis
· Failed previous fusion

Basis of Substantial

Equivalence:

The Active Anterior Cervical Plate System is substantially equivalent to the above listed predicate devices.

The substantially equivalent technological characteristics found in the Active Anterior Cervical Plate System include the following:

Augment stability of grafted segment PreView (K062371), CSLP (K030866)
Segmented plate to allow screw translation via carriages DOC (K982443), Vectra (K051665), Ant-Cer (K024326)
Combined use of two titanium alloys: Nitinol and Ti-6Al-4V Pioneer (K043066)
Compression applied to bone graft OSStaple (K061385), C-JAWS (K062181), C3 (K012881)

All of these technologies are substantially equivalent to those found among the predicate devices.

Mechanical performance attributes per ASTM F1717 were found to be substantially equivalent to those of predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sanacor, LLC % Mr. Michael Ensign Regulatory Manager 765 East 340 South, Suite 204 American Fork, Utah 84003-3348

JUL - 8 2008

Re: K073500

Trade/Device Name: Active™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: II Product Code: KWQ Dated: May 2, 2008 Received: May 5, 2008

Dear Mr. Ensign:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael Ensign

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Active™ Anterior Cervical Plate System

Indications for Use:

· Degenerative disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Spondylolisthesis
· Trauma (i.e., fracture or dislocation)
· Spinal stenosis
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

• Tumor

• Pseudoarthrosis

· Failed previous fusion
Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign Off

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

K0031

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.