COROENT XLR STANDALONE SYSTEM

K100043 · Nuvasive, Inc. · OVD · Jun 16, 2010 · Orthopedic

Device Facts

• Record ID: K100043
• Device Name: COROENT XLR STANDALONE SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Jun 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as an intervertebral body fusion device: The CoRoent XLR-Standalone System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent XLR-Standalone System is intended for use with autograft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent XLR-Standalone System. When used as a partial Vertebral Body Replacement (VBR): The CoRoent XLR-Standalone System is a standalone system indicated for use in the thoracolumbar spine (T1-L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CoRoent XLR-Standalone System is also indicated for treating fractures of the thoracic and lumbar spine. The CoRoent XLR-Standalone System is intended to be used with autograft or allograft.

Device Story

Implantable spinal fusion and partial vertebral body replacement system; manufactured from PEEK and titanium alloy. Available in various shapes/sizes to accommodate patient anatomy. Used by surgeons in clinical settings to stabilize the spine, restore vertebral height, and facilitate fusion. Functions as a standalone system; requires autograft (fusion) or autograft/allograft (VBR). Provides structural support for degenerative disc disease, tumor resection, or fracture treatment. Benefits include spinal stabilization and decompression of neural tissues.

Clinical Evidence

Bench testing only. Performed static and dynamic compression/torsion (ASTM F2077), wear debris analysis (ASTM F2077 & F1877), subsidence (ASTM F2267), and expulsion (ASTM Work Item Z8423Z). Results confirm performance meets or exceeds predicate devices.

Technological Characteristics

Materials: PEEK and titanium alloy. Standards: ASTM F2077 (compression/torsion/wear), ASTM F1877 (wear), ASTM F2267 (subsidence). Form factor: Implantable spinal spacer/VBR device. No software or energy source.

Indications for Use

Indicated for skeletally mature patients with lumbar DDD (L2-S1) with/without Grade 1 spondylolisthesis/retrolisthesis, or patients requiring partial VBR in the thoracolumbar spine (T1-L5) for tumors, spinal cord/neural tissue decompression, height restoration, or fractures. Requires 6 months non-operative treatment for DDD.

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 STALIF TT System (K073109)
• Blackstone Medical PILLAR SA PEEK Spacer System (K081849)
• Synthes SynFix-LR (K072253)
• Biomet Spine Solitaire Anterior Spinal System (K081501)
• Spinal Elements Lucent Magnum+ (K083475)

Submission Summary (Full Text)

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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:

JUN 1 J 2010

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

Date Prepared: June 4, 2010

#### B. Device Name

| | Trade or Proprietary Name: | NuVasive CoRoent® XLR Standalone System |
|----------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | Common or Usual Name: | Intervertebral Body Fusion Device, Spinal Partial<br>Vertebral Body Replacement Device |
| Classification Name: | Intervertebral Body Fusion Device, Spinal Partial<br>Vertebral Body Replacement Device | |
| Device Class: | Class II | |
| Classification: | §888.3060, §888.3080 | |
| Product Code: | MQP, MAX | |

#### C. Predicate Devices

The subject CoRoent® XLR Standalone System is substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:

- . K073109 - SurgiCraft STALIFTM TT System
- K081849 Blackstone Medical PILLARTM SA PEEK Spacer System ●
- K072253 - Synthes SynFix™-LR
- K081501 Biomet Spine Solitaire™ Anterior Spinal System ●
- K083475 Spinal Elements Lucent® Magnum+ ●

#### D. Device Description

The NuVasive CoRoent XLR-Standalone System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

#### E. Intended Use

When used as an intervertebral body fusion device:

The CoRoent XLR-Standalone System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or

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two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent XLR-Standalone System is intended for use with autograft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent XLR-Standalone System.

## When used as a partial Vertebral Body Replacement (VBR):

The CoRoent XLR-Standalone System is a standalone system indicated for use in the thoracolumbar spine (T1-L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CoRoent XLR-Standalone System is also indicated for treating fractures of the thoracic and lumbar spine. The CoRoent XLR-Standalone System is intended to be used with autograft or allograft.

#### F. Technological Characteristics

As was established in this submission, the subject CoRoent XLR-Standalone 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.

#### Performance Data G.

Nonclinical testing was performed to demonstrate that the subject CoRoent XLR-Standalone 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 ●
- Wear Debris per ASTM F2077 & ASTM F1877 ●
- . Subsidence per ASTM F2267
- Expulsion per ASTM Work Item Z8423Z .

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

#### H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject subject CoRoent XLR-Standalone System has

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Image /page/2/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the word "NUVASIVE" in all caps. Below the company name is the text "Creative Spine Technology" in a smaller font size.

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/3/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 image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines, and the overall design is simple and clean. The logo is often used to represent the department on official documents and websites.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

SEP 12 2011

Re: K100043 Trade/Device Name: NuVasive CoRoent® XLR Standalone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MOP Dated: May 18, 2010 Received: May 19, 2010

Dear Ms. Bruschi:

This letter corrects our substantially equivalent letter of June 16, 2010.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark A. Milkersen

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):

Device Name: NuVasive® CoRoent® XLR Standalone System

### Indications For Use:

### When used as an intervertebral body fusion device:

The CoRoene XLR-Standalone System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is delined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the invoived level(s). The CoRoent XLR-Standalone System is intended for use with autograft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent XLR-Standalone System.

### When used as a partial Vertebral Body Replacement (VBR):

The CoRoent XLR-Standalone System is a standalone system indicated for use in the thoracolumbar spine (T1-L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CoRoent XLR-Standalone System is also indicated for treating fractures of the thoracic and lumbar spine. The CoRoent XLR-Standalone System is intended to be used with autograft or allograft.

Prescription Use (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 Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________