NuVasive CoRoent Small Interlock II System

K170961 · Nu Vasive, Incorporated · OVE · Jun 8, 2017 · Orthopedic

Device Facts

• Record ID: K170961
• Device Name: NuVasive CoRoent Small Interlock II System
• Applicant: Nu Vasive, Incorporated
• Product Code: OVE · Orthopedic
• Decision Date: Jun 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Device Story

Anterior cervical interbody fusion system; consists of PEEK-OPTIMA implant cage with titanium coating, tantalum radiographic markers, titanium alloy washers, and three titanium alloy bone fixation screws. Used in cervical spine surgery to facilitate fusion; standalone for 7°-15° lordotic angles; requires supplemental fixation for 20°-30° angles. Implanted by surgeons to stabilize vertebral segments; bone graft (autogenous/allogeneic) packed into cage to promote fusion. Benefits include spinal stabilization and disc disease symptom relief.

Clinical Evidence

No clinical data. Bench testing only: static/dynamic compression and torsion (ASTM F2077), wear debris/mass change analysis (ASTM F1877/F1714), subsidence/push-out analysis, and bacterial endotoxin testing (ANSI/AAMI ST72).

Technological Characteristics

Materials: PEEK-Optima LT-1 (ASTM F2026), commercially pure titanium (ASTM F1580), titanium alloy (ASTM F136), tantalum (ASTM F560/ISO 13782). Implant cage with titanium coating and fixation screws. No software or electrical components.

Indications for Use

Indicated for skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1 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

• NuVasive CoRoent Small Interlock System (K161442)
• NuVasive CoRoent Interlock System (K102547)
• NuVasive CoRoent Interlock System (K142299)
• NuVasive CoRoent Ti-C System (K163707)
• NuVasive CoRoent Small Ti-C System (K162138)
• NuVasive CoRoent System (K081611)

Submission Summary (Full Text)

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Public Health Service

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

NuVasive, Incorporated Cynthia Adams Senior Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121

June 8, 2017

Re: K170961

Trade/Device Name: NuVasive CoRoent Small Interlock II System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: March 30, 2017 Received: March 31, 2017

Dear Ms. Adams:

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

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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.

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

K170961

Device Name

NuVasive CoRoent Small Interlock II System

### Indications for Use (Describe)

The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

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

| <div> <span style="font-size:100%;">☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|---------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:100%;">☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

#### A. Submitted by:

Cynthia Adams Sr. Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone]

Date Prepared: March 30, 2017

#### B. Device Name

| Trade or Proprietary Name: | NuVasive CoRoent Small Interlock II System |
|----------------------------|-------------------------------------------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Integrated<br>Fixation, Cervical |
| Device Class: | Class II |

| Device Class: | Class II |
|-----------------|-------------------|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | OVE |

#### C. Predicate Devices

The subject CoRoent Small Interlock II System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interlock System (K161442) serves as the primary predicate device, while NuVasive CoRoent Interlock System (K102547), NuVasive CoRoent Interlock System (K142299). NuVasive CoRoent Ti-C System (K163707). NuVasive CoRoent Small Ti-C System (K162138), and NuVasive CoRoent System (K081611) are additional predicate devices.

#### D. Device Description

The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody device consisting of a PEEK-OPTIMA® (poly-ether-ether-ketone) implant cage with commercially pure titanium coating, tantalum radiographic markers, titanium allov washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, titanium alloy conforming to ASTM F136 and tantalum conforming to ASTM F560 or ISO 13782. The implants are available in a variety of sizes to accommodate anatomical conditions.

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#### E. Indications for Use

The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

#### F. Technological Characteristics

As was established in this submission, the subject CoRoent Small Interlock II System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.

#### G. Performance Data

Nonclinical testing was performed to demonstrate that the subject CoRoent Small Interlock II System is substantially equivalent to other predicate devices. The following testing and analysis was performed:

- Static and dynamic compression testing per ASTM F2077 ●
- Static and dynamic torsion testing per ASTM F2077
- Wear debris/mass change analysis during ASTM F2077, per ASTM F1877 and ● ASTM F1714
- Subsidence and push-out analysis
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016 ●

The results of these studies show that the subject CoRoent Small Interlock II System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.

## H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CoRoent Small Interlock II System has been shown to be substantially equivalent to legally marketed predicate devices.