NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM

K142050 · Nu Vasive, Incorporated · ODP · Oct 29, 2014 · Orthopedic

Device Facts

• Record ID: K142050
• Device Name: NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM
• Applicant: Nu Vasive, Incorporated
• Product Code: ODP · Orthopedic
• Decision Date: Oct 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K142050 · Oct 29, 2014	NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM	Nu Vasive, Incorporated	Published clinical literature	A systematic literature review of published clinical data for cervical interbody fusion devices was used to support the expanded indications for use and demonstrate that the use of allogeneic bone graft with the device poses no new risks.	Literature review; Cervical interbody fusion; Clinical outcomes

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Systematic literature analysis of published clinical data; Systematic literature review	Patients with cervical degenerative pathologies undergoing anterior cervical interbody fusion	Not applicable for this study	Clinical outcomes of cervical interbody fusion using allogeneic bone graft

Indications for Use

The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - T1. The System is intended to be used with 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

Hollow interbody cage implant; manufactured from PEEK-Optima LT-1; features surface teeth to resist migration/expulsion; includes radiopaque marker pins (titanium alloy or tantalum) for radiographic positioning. Used in anterior cervical interbody fusion procedures; implanted by surgeons. Device provides structural support for spinal fusion; packed with bone graft to promote fusion; used with supplemental fixation. Benefits include stabilization of spinal segment in DDD patients. Provided non-sterile; requires user sterilization.

Clinical Evidence

No clinical trials performed. Evidence consists of a systematic literature review of published clinical data for similar cervical interbody fusion devices. Literature supports the safety and efficacy of using allogeneic cancellous, cortical, and corticocancellous bone graft with the subject device for cervical degenerative pathologies.

Technological Characteristics

Materials: PEEK-Optima LT-1 (ASTM F2026), titanium alloy (ASTM F136/ISO 5832-3), or tantalum (ASTM F560/ISO 13782). Principle: Intervertebral body fusion cage with hollow core for bone graft. Form factor: Various shapes/sizes with flat or contoured endplates. Sterilization: User-performed. No software or electrical components.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-T1. Requires supplemental fixation and use of autogenous/allogeneic bone graft. Patients must 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 Interbody System (K140003)
• NuVasive CoRoent System (K081611)
• Medtronic Anatomic PEEK Cervical Fusion System (K130177)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern.

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

October 29, 2014

NuVasive, Incorporated Ms. Michelle Cheung Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121

Re: K142050

Trade/Device Name: NuVasive® CoRoent® Small Contoured Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 1, 2014 Received: October 2, 2014

Dear Ms. Cheung:

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. Michelle Cheung

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/Resourcesfor You/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. Dean -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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# Indications for Use

## 510(k) Number (if known) K142050

Device Name

Nu Vasive® CoRoent® Small Contoured Interbody System

### Indications for Use (Describe)

The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - TI. The System is intended to be used with 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.

## 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

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

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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:

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

Date Prepared: October 27, 2014

#### B. Device Name

| Trade or Proprietary Name: | NuVasive® CoRoent® Small Contoured Interbody System |
|----------------------------|-----------------------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | 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 Contoured Interbody System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interbody System (K140003) serves as the primary predicate device; while NuVasive CoRoent System (K081611) and Medtronic Anatomic PEEK Cervical Fusion System (K130177) are referenced predicates.

#### D. Device Description

The NuVasive CoRoent Small Contoured Interbody System is a hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. The implant contains a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782. The pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation.

The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device will be packaged and initially provided non-sterile, and is designed to be sterilized by the user before each use.

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Image /page/4/Picture/0 description: The image contains the logo for Nuvasive. The logo features a stylized, curved shape in purple and gray on the left side. To the right of the shape is the company name "NUVASIVE" in gray, with the tagline "Speed of Innovation" in purple underneath.

#### E. Intended Use

The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured 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 System is intended for use with autogenous and/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.

#### F. Technological Characteristics

The subject CoRoent Small Contoured 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

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

- Static and dynamic axial compression per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- Subsidence Analysis per ASTM F2267 ●
- Clinical literature review ●

A systemic literature analysis of published clinical data for cervical interbody fusion devices similar to the CoRoent Small Contoured 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.

#### H. Conclusions

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