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,
Pseudoarthrosis; and
Previous failed fusion.
The Innovasis Opteryx™ Anterior Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.

Device Description

The Innovasis 'Optervx' Anterior Cervical Plate System is a 6AI-4V ELI Titanium Alloy device comprised of an anterior cervical fixation plate and various screws. The purpose of this device is to stabilize the anatomical positioning of the cervical vertebrae after surgery. The cervical plates will be available in a variety of sizes to allow for the treatment of a wide variety of differing cases. Screws of different types will be included in the sets as well. Fixed angle screws will be included for cases when it is important to maximize stability. Variable angle screws will be included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae. Differing lengths of screws will be provided in both the fixed and variable configurations, to allow for Unicortical or bicortical purchase.

AI/ML Overview

The Innovasis Opteryx™ Anterior Cervical Plate System is a medical device designed for anterior cervical fixation. It is composed of a titanium alloy plate and various screws, intended to stabilize the cervical vertebrae after surgery.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Static and Fatigue Testing: Characterize stiffness, strength, and fatigue life.	Performed. Properties of stiffness, strength, and fatigue life were characterized.
Biocompatibility: Device material must be biocompatible.	Made from 6AI-4V ELI Alloy Titanium per ASTM F136, a material proven to be biocompatible as an implant material.
Substantial Equivalence: Demonstrate substantial equivalence to predicate devices in indications for use, technology, and performance.	Subjected to risk analysis and testing per ASTM F1717 and shown to be substantially equivalent to Synthes 'CSLP' Cervical Spine Locking Plate (K000536), Theken 'Tether' Anterior Cervical Fixation System (K050451), and Medtronic 'Zephir' Anterior Cervical Plate System (K994239).
Safety and Effectiveness: Demonstrated to be safe and effective for use in anterior cervical fixation and associated indications.	Summary states the device is shown to be safe and effective.

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

The provided document describes non-clinical performance testing (static and fatigue testing) and a demonstration of substantial equivalence to predicate devices based on mechanical characteristics and intended use. There is no mention of a test set involving human subjects or clinical data in this 510(k) summary. The testing focused on the physical and mechanical properties of the device itself.

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

Not applicable. As noted above, the primary testing described is non-clinical performance data and a comparison to predicate devices, not human-centered testing requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is mentioned.

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 not an AI-enabled device; it is a physical medical implant. Therefore, no MRMC study or AI-related comparative effectiveness was performed.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance data, the "ground truth" would be established by engineering standards and specifications (e.g., ASTM F1717) for stiffness, strength, and fatigue life, and material composition standards (ASTM F136). For the substantial equivalence claim, the ground truth refers to the established safety and effectiveness of the identified predicate devices the new device is compared against.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore no "training set" in that context is used. The "training" for the device's design and manufacturing would come from established engineering principles and prior device knowledge.

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

Not applicable. (See point 8).

Summary

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JUN 3 0 2006

KOGHY7 Pg Lot 2

INNOVASIS, Inc.

614 East 3900 South Salt Lake City, UT 84107 801-261-2236 Fax 801-261-0573

Opteryx™ Anterior Cervical Plate System 510(k) Summary March 24, 2006

Company: Innovasis Inc 614 East 3900 South Salt Lake City, UT 84107 David N. McKean Contact: Phone: (801)261-2236 Fax: (801) 261-0573 Opteryx™ Anterior Cervical Plate System Trade Name: Anterior cervical fixation system and Instrumentation Common Name: KWQ 888.3060 - Spinal intervertebral body fixation Orthosis. Panel code: 87 Classification: Substantially Synthes 'CSLP' Cervical Spine Locking Plate (K000536), Equivalent Devices: -Theken 'Tether' Anterior Cervical Fixation System (K050451), --Medtronic 'Zephir' Anterior Cervical Plate System (K994239),

Device Description:

Performance Data:

Non-clinical: Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized.

Material:

The Innovasis Opteryx™ Anterior Cervical Plate System is made from 6AI-4V ELI Alloy Titanium per ASTM F136. This material has been proven to be biocompatible as an implant material.

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K06 1147 P3 2 of 2.

INNOVASIS, Inc.

614 East 3900 South Salt Lake City, UT 84107 801-261-2236 Fax 801-261-0573

Intended Use:

Indications for use are as follows:

The Innovasis Opteryx™ Cervical Plate System is intended for use in anterior cervical fixation for the following indications:

Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies),
Spondylolisthesis, l
Trauma (i.e., fracture or dislocation) .
. Spinal stenosis,
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
Tumor, .
Pseudoarthrosis; and .
Previous failed fusion. #

The Innovasis Opteryx™ Anterior Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.

Basis for Substantial Equivalence:

Anterior cervical plate fixation systems are a commonly used product in spinal orthopedics and the mechanical aspects and performance characteristics of such devices are widely known. The 'Opteryx' Anterior Cervical Plate System has been subjected to risk analysis and testing per ASTM F1717 and been shown to be substantially equivalent to the predicates:

Synthes 'CSLP' Cervical Spine Locking Plate (K000536), -
Theken 'Tether' Anterior Cervical Fixation System (K050451), -
Medtronic 'Zephir' Anterior Cervical Plate System (K994239), -

with regards to indications for use, technology and performance.

Summary of Safety and Effectiveness:

The Innovasis Opteryx™ Anterior Cervical Plate System is shown to be safe and effective for use in anterior cervical fixation and the indications associated with device product code KWQ.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2006

Innovasis, Inc. % Mr. David McKean Vice President of Operations 614 East 3900 South Salt Lake City, Utah 84107

Re: K061147

Trade/Device Name: Opteryx™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: Class II Product Code: KWQ Dated: June 23, 2006 Received: June 26, 2006

Dear Mr. McKean:

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 (Avt) 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. David McKean

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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510(k) Submission Innovasis 'Opteryx' Anterior Cervical Plate System

Indications of Use Statement

510(k) Number: 1(06/147

Device Name: Opteryx™ Cervica! Plate System

Indications for use are as follows:

The Innovasis Opteryx™ Cervical Plate System is intended for use in anterior cervical fixation for the following indications:

Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin . with degeneration of the disc confirmed by history and radiographic studies),
Spondylolisthesis, u
Trauma (i.e., fracture or dislocation) .
Spinal stenosis, .
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
Tumor. .
Pseudoarthrosis, and/or .
Previous failed fusion. .

The Innovasis Opteryx™ Anterior Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.

Prescription Use X (21 CFR 801 Subpart D)

Over-The-Counter-Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K061147

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.