COUGAR LS LATERAL CAGE SYSTEM

K110454 · Johnson & Johnson · MAX · May 13, 2011 · Orthopedic

Device Facts

• Record ID: K110454
• Device Name: COUGAR LS LATERAL CAGE SYSTEM
• Applicant: Johnson & Johnson
• Product Code: MAX · Orthopedic
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Cougar® LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation. The Cougar® LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

Device Story

Cougar® LS Lateral Cage System; PEEK/carbon fiber composite (CFRP) intervertebral body fusion/vertebral body replacement cages. Implants feature teeth for stability and cavities for autogenous bone graft; radiolucent with tantalum markers for radiographic assessment. Available in parallel or lordotic configurations; lateral surgical approach (open or minimally invasive). Used by surgeons to restore spinal height and biomechanical integrity; requires supplemental internal fixation. Benefits include spinal stabilization and fusion support in patients with DDD or vertebral body disease.

Clinical Evidence

Bench testing only. Static and dynamic compression testing performed per ASTM F2077 to characterize the device.

Technological Characteristics

Carbon-fiber reinforced PEEK (CFRP) cages; radiolucent with tantalum x-ray markers. Parallel or lordotic configurations. Dimensions include 6-10 mm heights. Mechanical testing per ASTM F2077.

Indications for Use

Indicated for skeletally mature patients requiring thoracolumbar (T1-L5) vertebral body replacement for tumors, decompression, or fracture treatment; or intervertebral body fusion (L2-S1) for degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis/retrolisthesis, following 6 months of failed 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

• DePuy Spine Cougar® LS Lateral Cage System (K081917, K090899)
• Globus Medical Patriot Spacers (K072970)
• NuVasive CoRoent System (K071795)
• DePuy Spine Concorde® Curve (K101923)

Submission Summary (Full Text)

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110454

# 510(K) SUMMARY

- A. Submitter Information
DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767

Contact Person:

Kevin G. Stevens Regulatory Affairs Project Manager [phone] [phone] [e-mail]

Cougar® LS Lateral Cage System

- B. Date Prepared
E-Mail:

Voice: Fax:

- April 15, 2011
- C. Device Name
Trade/Proprietary Name:

Common/Usual Name:

Spinal Intervertebral Body Fixation Orthosis, Spinal Intervertebral Fusion

Classification Name:

Spinal intervertebral body fixation orthosis per 21 CFR §888.3060 Intervertebral Body Fusion Device per 21 CFR §888.3080

#### D. Predicate Device Name

Trade name: DePuy Spine Cougar® LS Lateral Cage System (K081917, K090899) Globus Medical Patriot Spacers (K072970) NuVasive CoRoent System (K071795) DePuy Spine Concorde® Curve (K101923)

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### ui Device Description

The COUGAR® LS Lateral Cage System consists of the PEEK/carbon fiber composite cages (CFRP). Cages are available in parallel or lordotic configurations and are available in various sizes to match patient anatomy. The proposed devices in this submission include cages with smaller height dimensions (6-10 mm) to meet customer demand.

The cage structure is radiolucent with tantalum x-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft.

The implants may be utilized in either an open or minimally invasive surgical approach. The implants are placed using a lateral surgical approach. The implants are manufactured from PEEK Optima material.

### Intended Use F.

The Cougar® LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation.

The Cougar® LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

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# K 110454

### G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The proposed modifications to the DePuy Cougar® LS Lateral Cage Implants are the same as the predicate devices with one minor difference. The subject devices are offered in shorter heights than the predicate devices. The design has been modified slightly to provide the same strength and performance as the predicate devices. The materials, and technology remain identical to the predicate system.

### H. Materials

The proposed cages are manufactured from carbon-fiber reinforced PEEK material.

### Performance Data l.

Performance data per ASTM F2077 were submitted to characterize the subject Cougar® LS Lateral Cage Implants addressed in this notification. This testing was comprised of static and dynamic compression testing on the proposed device.

### J. Conclusion

Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

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

DePuy Spine, Inc. % Mr. Kevin G. Stevens Regulatory Affairs Project Manager 325 Paramount Drive Raynham, Massachusetts 02767

MAY 1 3 2011

Re: K110454

Trade/Device Name: Cougar® LS Lateral Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: April 15, 2011 Received: April 18, 2011

Dear Mr. Stevens:

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. Ilsting 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.

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Page 2 - Mr. Kevin G. Stevens

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 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/ReportalProblem/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.

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 STATEMENT

510(k) Number (if known):

k110454

Device Name: Cougar® LS Lateral Cage Implants

Indications For Use:

The Cougar® LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation.

The Cougar® LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

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) |
|--------------------------------------------------------------|
| (Division Sign-Off) |
| Division of Surgical, Orthopedic,<br>and Restorative Devices |

510(k) Number_________________________________________________________________________________________________________________________________________________________________

DePuy Spine, Inc., a Johnson & Johnson Company