COROENT SINGLE TAB SYSTEM

K131723 · Nuvasive, Inc. · OVD · Sep 20, 2013 · Orthopedic

Device Facts

• Record ID: K131723
• Device Name: COROENT SINGLE TAB SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Sep 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NuVasive CoRoent Single Tab System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The CoRoent Single-Tab System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screw.

Device Story

The CoRoent Single Tab System is an intervertebral body fusion device designed for lumbar spinal fusion. It consists of implants available in various shapes and sizes to accommodate patient anatomy. The device is used in conjunction with autogenous bone graft and supplemental internal spinal fixation (e.g., pedicle or facet screws) to stabilize the spine. It is intended for use in skeletally mature patients suffering from degenerative disc disease with up to Grade I spondylolisthesis. The device is implanted by a surgeon during a spinal fusion procedure. It provides structural support to the intervertebral space to facilitate fusion, thereby addressing back pain of discogenic origin.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence was demonstrated through bench testing, including static and dynamic axial compression and compression shear (ASTM F2077) and wear debris testing (ASTM F2077, ASTM F1714, ASTM F1877).

Technological Characteristics

Materials: PEEK-Optima LT-1 (ASTM F2026), MP35N (ASTM F562), titanium alloy (ASTM F136, ISO 5832-3). Form factor: Intervertebral body fusion implant with integrated screw. No software or electrical components.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous lumbar levels (L2-L5). Requires at least six months of failed non-operative treatment. Must be used with autogenous bone graft and supplemental FDA-cleared internal spinal 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

• NuVasive CoRoent System (K071795)
• NuVasive Sage Lateral Plate System (K121815)
• Globus InterContinental Plate-Spacer (K103382)

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 letter N on the left, followed by the word "NUVASIVE" in a sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font. The logo is simple and modern, and the tagline emphasizes the company's focus on innovation.

Traditional 510(k) Premarket Notification CoRoent Single Tab System

# 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:

Jeremy Markovich Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone]

**SEP 20 2013**

Date Prepared: September 19, 2013

#### B. Device Name

| Trade or Proprietary Name: | CoRoent Single Tab System |
|----------------------------|----------------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Spinal Intervertebral Body Fixation orthosis |

| Device Class: | Class II |
|-----------------|-------------------|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | OVD, MAX |

#### C. Predicate Devices

The subject CoRoent Single TabSystem is substantially equivalent to the following predicate devices: NuVasive CoRoent System (K071795), NuVasive Sage Lateral Plate System (K121815), and Globus InterContinental Plate-Spacer (K103382).

#### D. Device Description

The NuVasive CoRoent Single Tab System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, MP35N conforming to ASTM F562, and titanium alloy conforming to ASTM F136 and ISO 5832-3. 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/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized eye-like shape on the left, followed by the word "NUVASIVE" in a simple, sans-serif font. Below the company name, there is a tagline that reads "Speed of Innovation" in a smaller font size.

### Intended Use E.

The NuVasive CoRoent Single Tab System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent Single-Tab System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screw.

### F. Technological Characteristics

As was established in this submission. the subject CoRoent Single Tab 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

Bench testing was performed to demonstrate that the subject CoRoent Single Tab System is substantially equivalent to other predicate devices. The following testing was performed:

- Static and dynamic axial compression and compression shear per ASTM F2077 .
- Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877 .

The results demonstrate that the subject CoRoent Single Tab System presents no new worstcase for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate. No animal or clinical studies were conducted.

#### H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices. the subject CoRoent Single Tab 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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines above it.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 20, 2013

NuVasive, Incorporated Mr. Jeremy Markovich Senior Specialist Regulatory Affairs 7475 Lusk Boulevard San Diego. California 92121

Re: K131723

Trade/Device Name: NuVasive * CoRent * Single Tab System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: June 21, 2013 Received: June 24, 2013

Dear Mr. Markovich:

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. Iisting of devices, good manufacturing practice. Iabeling, 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

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Page 2 - Mr. Jeremy Markovich

device-related adverse events) (21 CFR 803); good 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark 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):__K131723

Device Name: NuVasive® CoRoent® Single Tab System

Indications For Use:

The NuVasive CoRoent Single Tab System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent Single Tab System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six months of non-operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screw.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices