Cavetto-SA Cervical Cage System

K200115 · Neurostructures, Inc. · OVE · Sep 24, 2020 · Orthopedic

Device Facts

• Record ID: K200115
• Device Name: Cavetto-SA Cervical Cage System
• Applicant: Neurostructures, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Sep 24, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.

Device Story

Cavetto®-SA Cervical Cage System is an intervertebral fusion device; used for single-level cervical spinal fusion (C2-T1). Device implanted via open, anterior approach; packed with autograft or allogenic bone graft. System includes integrated bone screws; requires no additional supplementary fixation. Used by surgeons in clinical settings to treat degenerative disc disease in skeletally mature patients. Provides structural support to facilitate fusion; benefits patients by stabilizing the spinal segment and alleviating discogenic pain.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by a comparison of material and technological characteristics to the predicate device in lieu of mechanical testing.

Technological Characteristics

Medical grade titanium per ASTM F136. Intervertebral fusion cage with integrated bone screws. Available in various footprints and sizes. Standalone system requiring no supplementary fixation. Mechanical/structural device; no software or energy source.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease of the cervical spine (C2-T1) requiring single-level spinal fusion. Patients must have discogenic pain confirmed by history and radiography and have failed six weeks of non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Cavetto-SA Cervical Cage System (K173077)

Reference Devices

• Ti-Diagon Oblique TLIF (K172064)
• Cavetto® Cervical Cage System (K172320)
• PorOsteon Phusion Metal Cervical Cage (K142041)
• Belvedere™ Lateral Plating System (K153097)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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.

September 24, 2020

NeuroStructures, Inc. % Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K200115

Trade/Device Name: Cavetto®-SA Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: August 26, 2020 Received: August 27, 2020

Dear Mr. Wright:

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.

{1}------------------------------------------------

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 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 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.

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K200115

Device Name Cavetto(R)-SA Cervical Cage System

#### Indications for Use (Describe)

The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D)</span> | <span style="white-space: nowrap;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C)</span> |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# K200115 - 510(K) SUMMARY

| Submitter's Name: | NeuroStructures, Inc. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 199 Technology Drive, Suite 110<br>Irvine, CA 92618 |
| Submitter's Telephone: | 800-352-6103 |
| Company Contact Person | Moti Altarac |
| Contact Person: | Nathan Wright<br>Empirical Testing Corp.<br>[e-mail]<br>719-337-7579 |
| Date Summary was Prepared: | January 15, 2020 |
| Trade or Proprietary Name: | Cavetto®-SA Cervical Cage System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Cervical<br>Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |
| Classification Panel: | Division of Orthopedic Devices |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Cavetto®-SA Cervical Cage System is an intervertebral fusion device made from medical grade titanium per ASTM F136. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.

# INDICATIONS FOR USE

The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.

# TECHNOLOGICAL CHARACTERISTICS

The Cavetto®-SA Cervical Cage System and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

{4}------------------------------------------------

- Principles of Operation ●
- Indications for Use .
- Implant Materials ●
- Implant Sizes ●
- Surgical Approach ●

| 510k<br>Number | Trade or Proprietary<br>or Model Name | Manufacturer | Predicate<br>Type |
|----------------|------------------------------------------|------------------------------|-------------------|
| K173077 | Cavetto-SA Cervical<br>Cage System | NeuroStructures | Primary |
| K172064 | Ti-Diagon Oblique<br>TLIF | Camber Spine<br>Technologies | Reference |
| K172320 | Cavetto® Cervical<br>Cage System | NeuroStructures,<br>Inc. | Reference |
| K142041 | PorOsteon Phusion<br>Metal Cervical Cage | PorOsteon, Inc. | Reference |
| K153097 | Belvedere™ Lateral<br>Plating System | Neurostructures | Reference |

Table 5-1: Predicate Devices

### PERFORMANCE DATA

A comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing.

### CONCLUSION

The overall technology and material characteristics lead to the conclusion that the Cavetto®-SA Cervical Cage System is substantially equivalent to the predicate device.