Oryx Cervical Plate System

K192049 · Innovasis, Inc. · KWQ · Nov 8, 2019 · Orthopedic

Device Facts

• Record ID: K192049
• Device Name: Oryx Cervical Plate System
• Applicant: Innovasis, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 8, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Innovasis Oryx Cervical Plate System is intended for use in Anterior Cervical Discectomy and Fusion (ACDF) procedures. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.

Device Story

Oryx Cervical Plate System is an anterior cervical fixation device consisting of titanium alloy plates and screws. Used by orthopedic surgeons in hospitals/surgical centers for spinal stabilization (C2-C7). Plates feature lordotic and transverse curvature for anatomical fit. Device provides mechanical support to the cervical spine to facilitate fusion in patients with degenerative, traumatic, or deformity-related conditions. Surgeon selects appropriate plate/screw sizes based on patient anatomy; implants are secured to the spine to provide rigid fixation. Benefits include stabilization of the cervical column, potentially reducing pain and restoring spinal alignment.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included static and dynamic compression, bending, and torsion per ASTM F1717, and axial pull-out, insertion/removal torque, and torsional yield strength per ASTM F543.

Technological Characteristics

Implant components: Ti6Al4V (ELI) titanium alloy (ASTM F136). Instruments/accessories: Surgical Stainless Steel (ASTM F899) and medical grade Silicone. Sterilization trays: Anodized 5052 Aluminum, Nylon, Stainless Steel, Polypropylene, and Radel (ASTM D6394 SP031). Design includes lordotic and transverse curvature plates. Mechanical fixation via screws.

Indications for Use

Indicated for anterior cervical fixation in patients requiring stabilization of the cervical spine from C2 to C7 for Degenerative Disc Disease (DDD), Spondylolisthesis, Trauma (fracture/dislocation), Spinal stenosis, Deformities (scoliosis, kyphosis, lordosis), Tumor, Pseudoarthrosis, and previous failed fusion.

Regulatory Classification

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.

Predicate Devices

• Synthes Anterior CSLP System (K030866)
• Innovasis Opteryx Anterior Cervical Plate System (K061147)

Submission Summary (Full Text)

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November 8, 2019

Innovasis, Inc. Marshall C. McCarty, RAC Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107

Re: K192049

Trade/Device Name: Oryx™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 13, 2019 Received: August 14, 2019

Dear Mr. McCarty:

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

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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 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 (OS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ronald P. Jean, Ph.D. Director (Acting) 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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# Indications for Use

510(k) Number (if known) K192049

Device Name OryxTM Cervical Plate System

#### Indications for Use (Describe)

- The Innovasis Oryx Cervical Plate System is intended for use in anterior cervical fixation for the following indications: i. Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc
- confirmed by history and radiographic studies),
- ii. Spondylolisthesis,
- iii. Trauma (i.e., fracture or dislocation)
- iv. Spinal stenosis.
- v. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- vi. Tumor,
- vii. Pseudoarthrosis: and
- viii. Previous failed fusion.

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

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in a bold, sans-serif font. Below the logo is the text "INNOVATE / INVOLVE / INVENT" in a smaller font. The logo is simple and modern, and the text below it suggests that the company is focused on innovation.

510(k)

#### 510(k) Summary Report: 5.0

# Oryx™ Cervical Plate System

| Company: | Innovasis, Inc. |
|----------|--------------------------|
| | 614 E. 3900 South |
| | Salt Lake City, UT 84107 |

Contact: Marshall McCarty Alternate: Michael Thomas Phone: [phone] x8012 [e-mail]

[phone] x8002 [e-mail]

- Trade Name: Oryx™ Cervical Plate System
- Common Name: Anterior cervical fixation system

Regulation No.: 21CFR 888.3060 Spinal Intervertebral Body Fixation Orthosis Classification: Class 2 Product Code: KWQ Review Panel: Orthopedic Review Team: ISDT

- Primary Predicte: K030866 Synthes Anterior CSLP System
- Additional: K061147 Innovasis Opteryx Anterior Cervical Plate System
- Device Description: The Oryx Cervical Plate System consists of a number of plates and screws of varying lengths. The plates feature lordotic curvature and a transverse plane curvature for an anatomical fit. The set contains ancillary products and instruments. All implant components are machined from implant grade titanium alloy, Ti6Al4V (ELI) per ASTM F136.
- (Non-clinical)—Performance testing on plates per ASTM F1717 Performance Data: for Static and Dynamic Compression Bend and Static Torsion and ASTM F543 for bone screw Axial Pull-Out, Insertion and Removal Torque and Torsional Yield Strength indicates that the Oryx Cervical Plate System is substantially equivalent to the predicate device.
- Materials: The Oryx implants are machined from medical grade Ti6Al4V (ELI) per ASTM F136. The Orvx instruments/accessories are machined from Surgical Stainless Steel per ASTM F899 and some have medical grade Silicone handles.

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| INNOVASIS<br>INNOVATE / INVOLVE / INVENT | Oryx™ Cervical Plate System | 510(k)<br>July 31, 2019<br>Page 11 of 107 |
|------------------------------------------|-----------------------------|-------------------------------------------|
|------------------------------------------|-----------------------------|-------------------------------------------|

The Oryx sterilization trays are comprised of Anodized 5052 Aluminum and have components made of Nylon. Stainless Steel. Polypropylene, and Radel per ASTM D6394 SP031.

The Oryx Cervical Plate System is intended for use in Anterior Intended Use: Cervical Discectomy and Fusion (ACDF) procedures. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.

Indications for Use: The Innovasis Oryx Cervical Plate System is intended for use in anterior cervical fixation for the following indications:

> i. Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

ii. Spondvlolisthesis.

iii. Trauma (i.e., fracture or dislocation)

- iv. Spinal stenosis.
v. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).

vi. Tumor.

- vii. Pseudarthrosis; and
viii. Previous failed fusion.

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

## Comparison of the Technological Characteristics with Predicate Device:

The Innovasis Oryx Cervical Plate System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the Synthes Anterior CSLP System (K030866) predicate.

- . Design configurations are substantially equivalent.
- . Applied mechanical loads are substantially equivalent.
- . Materials used are substantially equivalent.
- Biocompatibility requirements have been demonstrated. ●
- Intended Use and Indications for Use are substantially equivalent.
- Conclusion: Performance data and rationales submitted herein demonstrate that the subject Oryx Cervical Plate System is substantially equivalent to the predicate device with regard to design, technological characteristics, materials, performance, intended use and indications for use.