COROENT XL-F SYSTEM

K140479 · Nu Vasive, Incorporated · OVD · Jul 28, 2014 · Orthopedic

Device Facts

• Record ID: K140479
• Device Name: COROENT XL-F SYSTEM
• Applicant: Nu Vasive, Incorporated
• Product Code: OVD · 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 XL-F 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 XL-F 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 screws.

Device Story

The NuVasive CoRoent XL-F System is an intervertebral body fusion device designed for lumbar spinal surgery. Implants are available in various shapes and sizes to accommodate patient anatomy and pathology. The device is implanted by a surgeon during spinal fusion procedures to stabilize the disc space and facilitate fusion when used with autogenous bone graft. It is intended for use in conjunction with supplemental internal spinal fixation systems, such as pedicle or facet screws. The device provides structural support to the intervertebral space, aiding in the treatment of degenerative disc disease and spondylolisthesis. It is a mechanical implant system and does not involve electronic or software components.

Clinical Evidence

No clinical studies were conducted. Evidence consists of bench testing, including axial compression and compression shear finite element analysis, wear debris analysis, subsidence analysis, and a cadaveric study. Clinical literature analysis was also performed.

Technological Characteristics

Constructed from PEEK-Optima LT-1 (ASTM F2026), MP35N (ASTM F562), and titanium alloy (ASTM F136, ISO 5832-3). The device is a mechanical intervertebral body fusion implant. No software or electrical components are present.

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 prior non-operative treatment. Must be used with autogenous bone graft and supplemental 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 Single Tab System (K131723)
• NuVasive Brigade Hyperlordotic System (K123045)
• Globus Medical 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 leaf-like shape 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.

Traditional 510(k) Premarket Notification NuVasive® CoRoent® XL-F 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:

#### Submitted by: A.

Cynthia Adams Regulatorv Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone]

Date Prepared: July 23, 2014

#### B. Device Name

NuVasive® CoRoent® XL-F System Trade or Proprietary Name: Common or Usual Name: Intervertebral Body Fusion Device Spinal Intervertebral Body Fixation orthosis Classification Name:

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

#### C. Predicate Devices

The subject NuVasive CoRoent XL-F System is substantially equivalent to the following predicate devices: NuVasive Single Tab System (K131723), NuVasive Brigade Hyperlordotic System (K123045), and Globus Medical InterContinental Plate-Spacer (K103382).

#### D. Device Description

The NuVasive CoRoent XL-F 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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#### E. Intended Use

The NuVasive CoRoent XL-F 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 XL-F 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 screws.

#### Technological Characteristics F.

As was established in this submission, the subject CoRoent XL-F 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

The following activities were performed to demonstrate that the subject CoRoent XL-F System is substantially equivalent to other predicate devices for the following:

- Axial Compression Finite Element Analysis .
- Compression Shear Finite Element Analysis .
- Wear Debris Analysis .
- Subsidence Analysis .
- Clinical literature analysis .
- Cadaveric study .

The results demonstrate that the subject CoRoent XL-F System presents no new worst-case for performance testing, and a cadaveric study did not identify any new risks associated with the subject device. The subject device was therefore found to be substantially equivalent to its predicate devices. No clinical studies were conducted.

#### H. Conclusions

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health 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

Rc: K140479

Trade/Device Name: NuVasive® CoRoent® XL-F System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: June 17, 2014 Received: June 18, 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/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 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) KI40479

Device Name NuVasive® CoRoent® XL-F System

### Indications for Use (Describe)

The NuVasive CoRoent XL-F 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 XL-F 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 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 screws.

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

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 . . . . . . . . . . . .. 11.15

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

# Katherine D. Kavlock, PhD

## Division of Orthopedic Devices

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