CAVUX CervicalCage-L SA System

K163474 · Providence Medical Technology, Inc. · OVE · Mar 10, 2017 · Orthopedic

Device Facts

• Record ID: K163474
• Device Name: CAVUX CervicalCage-L SA System
• Applicant: Providence Medical Technology, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Mar 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CAVUX™ Cervical Cage-L SA System is indicated for standalone use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device. CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.

Device Story

Intervertebral body fusion device; rectangular hollow box shape; titanium construction; includes self-drilling/self-tapping screws. Used in cervical spine surgery to facilitate fusion at one disc level. Implanted by surgeons; requires autogenous or allogenic bone graft. Provides standalone fixation; eliminates need for supplementary fixation systems. Benefits patients by stabilizing the disc space and promoting fusion in DDD cases.

Clinical Evidence

Bench testing only. Testing included static/dynamic axial compression, torsion, shear, and static expulsion per ASTM F2077-14 and ASTM Draft F-04.25.02.02. Results demonstrate mechanical strength sufficient for intended use.

Technological Characteristics

Medical grade titanium; rectangular hollow box geometry with surface teeth; standalone system with integrated bone screws; terminally sterilized; single-use.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) with radicular symptoms, who have failed at least 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

• STALIF C® (K150053, K142079, K120819)
• AVS® Anchor-C Cervical Cage System (K102606)
• TOMCAT™ Cervical Spinal System (K152515)
• ROI-C (K150765, K121103, K113559)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2017

Providence Medical Technology, Inc. % Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K163474

Trade/Device Name: CAVUX™ Cervical Cage-L SA System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: February 10, 2017 Received: February 14, 2017

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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### Indications for Use

510(k) Number (if known) K163474

Device Name CAVUX™ Cervical Cage-L SA System

#### Indications for Use (Describe)

CAVUX™ Cervical Cage-L SA System is indicated for standalone use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device.

CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(K) SUMMARY

| Submitter's Name: | Providence Medical Technology, Inc. |
|----------------------------|------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 1331 N. California Blvd Suite 320<br>Walnut Creek, CA 94596 |
| Submitter's Telephone: | 415.923.9376 |
| Contact Person: | Kenneth C. Maxwell II<br>Empirical Testing Corp.<br>719.291.6874<br>[e-mail] |
| Date Summary was Prepared: | 10 February 2017 |
| Trade or Proprietary Name: | CAVUX™ Cervical Cage-L SA System |
| Common or Usual Name: | Intervertebral Fusion Device With Integrated Fixation,<br>Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Providence Medical Technology, Inc. CAVUX™ Cervical Cage-L SA System is supplied terminally sterilized and is single-use only. The subject device is manufactured from medical grade titanium and is available in various sizes. Subject device is a rectangular hollow box shape with space for allogenic and autogenous bone graft and teeth on the inferior and superior surfaces of the implant. Self-drilling and self-tapping screws are provided as part of the subject device.

#### INDICATIONS FOR USE

CAVUX™ Cervical Cage-L SA System is indicated for standalone use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device.

CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.

The indications for use for the CAVUX™ Cervical Cage-L SA System is similar to that of the predicates listed in Table 5-1.

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| 510k Number | Trade or Proprietary<br>or Model Name | Manufacturer | Predicate<br>Type |
|---------------------------------------|---------------------------------------|----------------|-------------------|
| K150053 K142079,<br>K120819 | STALIF C® | Centinel Spine | Primary |
| K102606 | AVS® Anchor-C<br>Cervical Cage System | Stryker Spine | Additional |
| K152515 | TOMCAT™ Cervical<br>Spinal System | Choice Spine | Additional |
| K150765, K121103,<br>K113559, K113559 | ROI-C | LDR | Additional |

Table 5-1: Predicate Devices

## PERFORMANCE DATA

The CAVUX™ Cervical Cage-L SA System has been tested in the following test modes:

- ASTM F2077-14 .
- o Static Axial Compression
- O Static Torsion
- o Static Shear
- o Dynamic Axial Compression
- o Dynamic Shear
- . ASTM Draft F-04.25.02.02
- O Static Expulsion

The results of this non-clinical testing show that the strength of the CAVUX™ Cervical Cage-L SA 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 CAVUX™ Cervical Cage-L SA System is substantially equivalent to the predicate device.