Cavetto-SA Cervical Cage System

K173077 · Neurostructures, Inc. · OVE · Feb 23, 2018 · Orthopedic

Device Facts

• Record ID: K173077
• Device Name: Cavetto-SA Cervical Cage System
• Applicant: Neurostructures, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Feb 23, 2018
• Decision: SESE
• Submission Type: Traditional
• 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 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.

Device Story

Intervertebral body fusion device; provides structural support for cervical spine fusion. Implanted via open, anterior approach; packed with autograft or allogenic bone graft. System includes PEEK cage, titanium components, and tantalum markers; utilizes integrated bone screws for fixation. Used by surgeons in clinical settings to treat degenerative disc disease. Device stabilizes vertebral segments to facilitate fusion; eliminates need for supplementary fixation systems. Benefits patients by providing mechanical stability during bone healing process.

Clinical Evidence

Bench testing only. Performance evaluated via static and dynamic axial compression, compressive shear, and torsion per ASTM F2077; static subsidence per ASTM F2267; and expulsion testing per ASTM F-04.25.02.02. Results demonstrate mechanical strength sufficient for intended use.

Technological Characteristics

Materials: PEEK (ASTM F2026), titanium (ASTM F560), tantalum markers (ASTM F560). Form factor: Intervertebral cage with integrated bone screws. Principle: Mechanical stabilization for spinal fusion. No energy source or software.

Indications for Use

Indicated for spinal fusion at one level (C2-T1) in skeletally mature patients with degenerative disc disease of the cervical spine, following six weeks of failed 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

• Optio-CTM (K132894)
• Tesera (K153250)
• STALIF C® (K150053)
• TOMCAT™ (K152515)
• AVS Anchor-C (K102606)

Submission Summary (Full Text)

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February 23, 2018

NeuroStructures, Inc. % Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, California 80918

Re: K173077

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: January 19, 2018 Received: January 22, 2018

Dear Mr. Maxwell:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173077 Device Name Cavetto®-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 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.

| Type of Use (Select one or both, as applicable) | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><span> <div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" src="checkbox_checked.png" style="width:15px; height:15px; vertical-align:middle;"/> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span> <div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width:15px; height:15px; vertical-align:middle;"/> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" src="checkbox_checked.png" style="width:15px; height:15px; vertical-align:middle;"/> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width:15px; height:15px; vertical-align:middle;"/> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
| <span> <div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" src="checkbox_checked.png" style="width:15px; height:15px; vertical-align:middle;"/> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width:15px; height:15px; vertical-align:middle;"/> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |

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### 510(K) SUMMARY

| Submitter's Name: | Neurostructures, Inc. |
|----------------------------|------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 16 Technology Drive, Suite 165<br>Irvine, CA 92618 |
| Submitter's Telephone: | Kathleen Wong<br>[e-mail]<br>949.370.4497 |
| Contact Person: | Kenneth C. Maxwell II<br>Empirical Testing Corp.<br>719.291.6874<br>[e-mail] |
| Date Summary was Prepared: | 20 February 2018 |
| Trade or Proprietary Name: | Cavetto®-SA Cervical Cage System |
| Common or Usual Name: | 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 PEEK per ASTM F2026, titanium per ASTM F560, and tantalum markers per ASTM F560. 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

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effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- . Indications for Use
- Principle of operation ●
- Implant material PEEK ●
- Implant material titanium ●
- Screw implant diameter and length ●
- Structural support mechanism .
- . Cage implant sizes

Table 5-1: Predicate Devices

| 510k<br>Number | Trade or Proprietary<br>or Model Name | Manufacturer | Predicate<br>Type |
|----------------|---------------------------------------|----------------|-------------------|
| K132894 | Optio-CTM | Zimmer Spine | Primary |
| K153250 | Tesera | Renovis | Additional |
| K150053 | STALIF C® | Centinel Spine | Additional |
| K152515 | TOMCAT™ | Choice Spine | Additional |
| K102606 | AVS Anchor-C | Stryker Spine | Additional |

# PERFORMANCE DATA

The Cavetto®-SA Cervical Cage System has been tested in the following test modes:

- Static axial compression per ASTM F2077 ●
- Static compressive shear per ASTM F2077 .
- Static torsion per ASTM F2077 ●
- Dynamic axial compression per ASTM F2077 .
- Dynamic compressive shear per ASTM F2077 .
- Dynamic torsion per ASTM F2077 ●
- Static subsidence per ASTM F2267 .
- Expulsion per ASTM F-04.25.02.02 ●

The results of this non-clinical testing show that the strength of the Cavetto®-SA Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

# CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Cavetto@-SA Cervical Cage System is substantially equivalent to the predicate device.