Paramount Anterior Cervical Cage System

K173175 · Spine Wave, Inc. · OVE · Nov 1, 2017 · Orthopedic

Device Facts

• Record ID: K173175
• Device Name: Paramount Anterior Cervical Cage System
• Applicant: Spine Wave, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Nov 1, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Paramount® Anterior Cervical Cage System is indicated for 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 history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. Paramount® Anterior Cervical Cage System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.

Device Story

Paramount® Anterior Cervical Cage System is a sterile, single-use interbody fusion device. Components include cage body, anchor plate, and graft containment plate. Surgeon inserts cage into disc space via open anterior approach using dedicated inserter; deploys anchor plate into adjacent vertebral bodies; packs cage with autogenous bone graft; snaps graft cap in situ. Device provides structural support for fusion. Used in clinical settings by surgeons. Benefits include stabilization of cervical spine segment in DDD patients.

Clinical Evidence

No clinical data. Bench testing only. Sterilization validated per ISO 11137; biocompatibility per ISO 10993; shelf life per ASTM F1980; bacterial endotoxin testing per ANSI/AAMI ST72:2011.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V, ASTM F136), commercially pure titanium (ASTM F67), PEEK-OPTIMA with 6% BaSO4. Mechanical interbody fusion cage with integrated anchor plate. Sterile, single-use. Gamma sterilization.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) and radicular symptoms at one level (C2-T1). Requires 6 weeks of failed non-operative treatment. Contraindicated in patients without skeletal maturity or those not requiring supplemental posterior fixation.

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

• Spine Wave Anterior Cervical Spine System (K162760)

Submission Summary (Full Text)

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November 1, 2017

Spine Wave, Inc. Yvonne Riley-Poku Associate Regulatory Affairs Specialist 3 Enterprise Drive Suite 210 Shelton, Connecticut 06484

Re: K173175

Trade/Device Name: Paramount® Anterior Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: September 28, 2017 Received: September 29, 2017

Dear Yvonne Riley-Poku:

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) 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 (DICE) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K173175

Device Name

Paramount® Anterior Cervical Cage System

#### Indications for Use (Describe)

The Paramount® Anterior Cervical Cage System is indicated for 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 history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. Paramount® Anterior Cervical Cage System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="font-family: Arial;"> X Prescription Use (Part 21 CFR 801 Subpart D)</span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary Paramount® Anterior Cervical Cage System Sterile Implants

## 1. Submitter Information

| Submitter: | Spine Wave, Inc. |
|----------------|----------------------------------------------------------|
| Address: | Three Enterprise Drive<br>Suite 210<br>Shelton, CT 06484 |
| Contact: | Yvonne Riley-Poku |
| Date Prepared: | September 28, 2017 |

## 2. Device Information

| Trade Name: | Paramount® Anterior Cervical Cage System |
|----------------------|--------------------------------------------------------------------|
| Common Name: | Intervertebral Fusion Device with Integrated Fixation,<br>Cervical |
| Classification: | Class II (special controls) per 21 CFR 888.3080 |
| Classification Name: | Intervertebral Body Fusion Device |
| Product Code: | OVE |

### 3. Purpose of Submission

The purpose of this submission is to provide the implant as a sterile packed option.

## 4. Predicate Device Information

The Paramount® Anterior Cervical Cage System described in this submission is substantially equivalent to the following:

| Primary Predicate Device | Manufacturer | 510(k) No. |
|-------------------------------------------|------------------|------------|
| Spine Wave Anterior Cervical Spine System | Spine Wave, Inc. | K162760 |

# 5. Device Description

The Paramount® Anterior Cervical Cage System consists of a selection of sterile, single use cervical interbody cages indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1.

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The Paramount® Anterior Cervical Cage System cages are multi-component devices comprised of a cage body, anchor plate and graft containment plate. Spine Wave supplies the cage body and anchor plate as a paired combination, and the surgeon assembles the graft cap in situ. The Paramount® Anterior Cervical Cage system cages are offered in a variety of sizes and shapes to accommodate different patient anatomies and manufactured from titanium alloy (Ti-6Al-4V per ASTM F136), commercially pure titanium (ASTM F67) and PEEK-OPTIMA with 6% BaSO4.

Using the Paramount® Anterior Cervical Cage Inserter, the surgeon places the cage body with undeployed anchor plate into the disc space. After placement, the surgeon uses the cage inserter to deploy the superior and inferior portions of the anchor plate into the adjacent vertebral bodies and pack the open end of the cage with autograft. Once grafting is complete, the surgeon snaps the graft cap into the open end of the cage.

#### 6. Indications for Use

The Paramount® Anterior Cervical Cage System is indicated for 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 history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. The Paramount® Anterior Cervical Cage System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.

### 7. Comparison of Technological Characteristics

The substantial equivalence of the Paramount® Anterior Cervical Cage System to the listed predicate is shown by similarity in intended use, indications for use, materials and performance.

### 8. Performance Testing

No performance testing was required, because the proposed level of gamma sterilization to the modified device does not change the strength and performance characteristics of the materials present in the modified device. The subject device is therefore substantially equivalent to the predicate in performance testing. The sterile-pack implants was evaluated in accordance with the following standards:

- Sterilization validation in accordance with ISO 11137
- Biocompatibility assessment per ISO 10993 ●
- Shelf life validation in accordance with ASTM F1980 ●

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- Bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST-● 72:2011
## 9. Conclusion

Based on the indications for use, technical characteristics, performance testing, and comparison to the predicate, the Paramount® Anterior Cervical Cage System is substantially equivalent to the predicate device identified in this submission and does not present any new issues of safety or effectiveness.