COROENT SMALL INTERBODY SYSTEM

K140921 · Nu Vasive, Incorporated · ODP · Jul 28, 2014 · Orthopedic

Device Facts

• Record ID: K140921
• Device Name: COROENT SMALL INTERBODY SYSTEM
• Applicant: Nu Vasive, Incorporated
• Product Code: ODP · Orthopedic
• Decision Date: Jul 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/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.

Device Story

The NuVasive CoRoent Small Interbody System consists of spinal implants designed for anterior cervical interbody fusion. Implants are placed surgically by a physician to facilitate fusion in patients with cervical disc disease. The system requires the use of supplemental anterior cervical plate fixation and bone graft (autogenous or allogeneic). The device provides structural support to the intervertebral space to promote spinal fusion, potentially alleviating symptoms associated with degenerative disc disease. It is intended for use in a clinical/surgical setting.

Clinical Evidence

No clinical trials were performed for this submission. Evidence consists of a systemic literature analysis of published clinical data for cervical interbody fusion devices similar to the CoRoent Small Interbody System. The analysis demonstrated that the use of allogeneic cancellous, cortical, and/or corticocancellous bone graft with the subject device for cervical degenerative pathologies poses no new risks to patients.

Technological Characteristics

Implants manufactured from PEEK-Optima LT-1 (ASTM F2026), titanium alloy (ASTM F136, ISO 5832-3), or tantalum (ASTM F560, ISO 13782). Available in various shapes and sizes. Non-electrical, no software.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. Requires at least six weeks of prior non-operative treatment. Must be used with supplemental anterior cervical plate fixation and autogenous/allogeneic bone graft.

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 System (K081611)
• NuVasive CoRoent Small Interbody System (K14003)
• Medtronic Anatomic PEEK Cervical Fusion System (K130177)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized black graphic on the left, followed by the word "NUVASIVE" in a simple, sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size.

### 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 Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone]

Date Prepared: July 2, 2014

#### B. Device Name

Trade or Proprietary Name: Common or Usual Name: Classification Name:

NuVasive® CoRoent® Small Interbody System Intervertebral Body Fusion Device Intervertebral Body Fusion Device with Bone Graft, Cervical

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

#### C. Predicate Devices

The subject CoRoent Small Interbody System is substantially equivalent to the following predicate devices: NuVasive CoRoent System (K081611), NuVasive CoRoent Small Interbody System (K14003), and Medtronic Anatomic PEEK Cervical Fusion System (K130177).

#### Device Description D.

The NuVasive CoRoent Small Interbody System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, and titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

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Image /page/1/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized black and white graphic to the left of the word "NUVASIVE" in a simple sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font.

#### E. Intended Use

The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/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

The subject CoRoent Small Interbody 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 have equivalent 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

The purpose of this 510(k) is to modify the Indications for Use for the subject CoRoent Small Interbody System. A systemic literature analysis of published clinical data for cervical interbody fusion devices similar to the CoRoent Small Interbody System was provided as performance data to support the expanded Indications for Use. For treatment of cervical degenerative pathologies in anterior cervical interbody fusion surgical procedures, the published clinical outcomes demonstrate that the use of allogeneic cancellous, cortical and/or corticocancellous bone graft with the subject device poses no new risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional nonclinical testing was required or performed.

#### H. Conclusions

Based on the indications for use, technological characteristics, clinical literature analysis, and comparison to predicate devices, the subject CoRoent Small Interbody System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public I lealth Service

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

July 28, 2014

NuVasive, Incorporated Ms. Cynthia Adams Regulatory Affairs Associate 7475 Lusk Boulevard San Diego. California 92121

Re: K140921

Trade/Device Name: NuVasive® CoRoent® Small Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 2, 2014 Received: July 3. 2014

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Cynthia Adams

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/Safetv/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Ronald P. Jean -S for

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: January 31, 2017 See PRA Statement below.

### 510(k) Number (if known)

K140921

#### Device Name

NuVasive® CoRocnt® Small Interbody System

#### Indications for Use (Describe)

The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is interior cervical interbody fusion in patients with cervical disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation: the CoRoent SYL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The ccrvical 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Katherine D. Kavlock, PhD

## Division of Orthopedic Devices

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