COROENT INTERLOCK SYSTEM

K102547 · Nuvasive, Inc. · OVE · Feb 7, 2011 · Orthopedic

Device Facts

• Record ID: K102547
• Device Name: COROENT INTERLOCK SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Feb 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoRoent® Small Interlock System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.

Device Story

Standalone anterior cervical interbody fusion system; consists of PEEK implant cage, titanium alloy markers/washers, and three titanium alloy bone fixation screws. Used in surgical setting by physicians to treat degenerative disc disease. Implant provides structural support and stabilization at one cervical level (C2-T1) to facilitate fusion; requires no additional supplementary fixation. Autograft is packed into the cage to promote bone growth. Benefits include stabilization of the spinal segment and potential reduction of discogenic pain.

Clinical Evidence

No clinical data. Substantial equivalence established via nonclinical bench testing: static and dynamic torsion (ASTM F2077), static and dynamic compression (ASTM F2077), subsidence (ASTM F2267), and wear debris (ASTM F2077 & ASTM F1877).

Technological Characteristics

Standalone anterior cervical interbody fusion cage. Materials: PEEK (polyetheretherketone) cage, titanium alloy (ASTM F136) markers, washers, and bone screws. Mechanical testing per ASTM F2077 and F2267. No energy source or software.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1, defined as discogenic back pain with radiographic confirmation. Requires at least 6 weeks of prior non-operative treatment. Intended for use with autograft.

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

• Surgicraft Limited STALIFTM C (K072415)
• Synthes Spine Synthes Zero-P (K072981)
• Globus Medical Coalition™ Spacer (K083389)
• Medtronic Sofamor Danek PEEK PREVAIL™ Cervical Interbody Device (K094042)
• NuVasive, Inc. CoRoent XLR Standalone System (K100043)

Reference Devices

• SeaSpine, Inc. Zuma-CTM (K092521)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic on the left and the word "NUVASIVE" in a bold, sans-serif font on the right. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font. The graphic on the left appears to be an abstract representation of a curved shape.

# 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.

Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Fax: [phone]

FEB - 7 2011

Date Prepared: August 30, 2010

#### Device Name B.

Common or Usual Name: Classification Name: Device Class: Classification: Product Code:

Trade or Proprietary Name: NuVasive® CoRoent® Small Interlock™ System Intervertebral Body Fusion Device Intervertebral Body Fusion Device Class II 8888.3080 ODP

## Predicate Devices C.

The subject CoRoent Small Interlock System is substantially equivalent to the following devices previously cleared by FDA:

- · K072415 Surgicraft Limited STALIFTM C
- · K072981- Synthes Spine Synthes Zero-P
- · K083389 Globus Medical Coalition™ Spacer
- · K094042- Medtronic Sofamor Danek PEEK PREVAIL™ Cervical Interbody Device
- · K092521- SeaSpine, Inc. Zuma-CTM
- · K100043- NuVasive, Inc. CoRoent XLR Standalone System

## Device Description D.

The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with titanium alloy Sevious markers and washers, and three (3) titanium alloy bone fixation screws. The de roos alloy conforming to ASTM F136. The implants are available in a variety of sizes The CoRoent Small Interlock System is a to accommodate anatomical conditions. standalone system intended to be used with the bone screws provided, and when used as such requires no additional supplementary fixation systems.

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K102547

Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized abstract shape on the left, followed by the word "NUVASIVE" in a blocky, outlined font. Below the word "NUVASIVE" is the tagline "speed of innovation" in a smaller, sans-serif font.

# 510(k) Premarket Notification K102547 NuVasive® CoRoent® Small Interlock™ System

# E. Intended Use

The CoRoent® Small Interlock System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.

# F. Technological Characteristics

As was established in this submission, the subject CoRoent Small Interlock 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, function, and range of sizes.

## G. Performance Data

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

- Static and dynamic torsion per ASTM F2077 .
- Static and dynamic compression per ASTM F2077 .
- . Subsidence per ASTM F2267
- Wear Debris per ASTM F2077 & ASTM F1877 .

The results of these studies showed that the subject CoRoent Small Interlock System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

## Conclusions H.

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

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

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

NuVasive, Inc. % Ms. Sheila Bruschi Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

.............................................................................................................................................................................. SEF

Re: K102547

Trade/Device Name: NuVasive® CoRoent® Small Interlock™ System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: January 10, 2011 Received: January 11, 2011

Dear Ms. Bruschi:

This letter corrects our substantially equivalent letter of February 7, 2011.

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 (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.

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

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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 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A Millberson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K102547

Device Name: NuVasive® CoRoent® Small Interlock™ System

Indications For Use:

The CoRoent Small Interlock™ System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease TODD at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorauve ذنت:د:ندن

ל X102547 510(k) Number_

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