COUGAR SYSTEM

K113348 · Johnson & Johnson · MAX · Dec 13, 2011 · Orthopedic

Device Facts

• Record ID: K113348
• Device Name: COUGAR SYSTEM
• Applicant: Johnson & Johnson
• Product Code: MAX · Orthopedic
• Decision Date: Dec 13, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The COUGAR System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation. The COUGAR System is indicated for use in the thoracolumbar spine (i.e., T1-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. The COUGAR System is also indicated for treating fractures of the thoracic and lumbar spine. The COUGAR 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, the COUGAR System is intended for use with DePuy Spine supplemental internal fixation.

Device Story

Cougar Implant System consists of lordotic-configured cages with open architecture for autogenous bone graft packing; used as intervertebral body fusion or vertebral body replacement device; implanted via anterior approach; requires supplemental internal fixation. Device restores spinal column biomechanical integrity, height of collapsed vertebral bodies, and facilitates fusion. Used in clinical settings by surgeons; provides structural support to spinal column.

Clinical Evidence

Bench testing only. Testing performed per ASTM F2077-11 and ASTM F2267-04, including static and dynamic compression, subsidence, and expulsion testing.

Technological Characteristics

Carbon-fiber reinforced PEEK Optima material. Open architecture cage design with varying heights and lordotic configurations. Testing standards: ASTM F2077-11, ASTM F2267-04.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain, L2-S1, 1-2 levels, 6 months failed non-operative treatment) requiring intervertebral fusion; also indicated for thoracolumbar (T1-L5) vertebral body replacement due to tumor resection, decompression, or fracture 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® System (K081917)
• DePuy Spine X-Mesh System (K080568)
• DePuy Spine Leopard® System (K031635)
• DePuy Spine Cougar LS Lateral Cage® System (K110454)
• DePuy Spine Concorde Curve® System (K101923)

Submission Summary (Full Text)

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DEC 1 3 2011

## 510(K) SUMMARY

B.

C.

#### Submitter Information A.

| | DePuy Spine, Inc. |
|--|---------------------|
| | 325 Paramount Drive |
| | Raynham, MA 02767 |

| Contact Person: | Kevin G. Stevens |
|-------------------------|------------------------------------------------------------------------------------------------------------------|
| Address: | 325 Paramount Drive |
| | Raynham, MA 02767 |
| Telephone number: | 508-977-6445 |
| Fax number: | 508-828-3797 |
| Email: | [e-mail] |
| Date Prepared | November 11, 2011 |
| Device Name | |
| Trade/Proprietary Name: | Cougar® Implant System |
| Classification Name: | Spinal Vertebral Body Replacement Device 21 CFR 888.3060, Orthosis, Spinal Intervertebral Fusion 21 CFR 888.3080 |

### Predicate Device Name D.

DePuy Spine Cougar® System (K081917) Trade name: DePuy Spine X-Mesh System (K080568) DePuy Spine Leopard® System (K031635) DePuy Spine Cougar LS Lateral Cage® System (K110454) DePuy Spine Concorde Curve® System (K101923)

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### Device Description E.

The Cougar® System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of autogenous bone graft materials.

### Intended Use F.

The COUGAR System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation.

The COUGAR System is indicated for use in the thoracolumbar spine (i.e., T1-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. The COUGAR System is also indicated for treating fractures of the thoracic and lumbar spine. The COUGAR 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, the COUGAR System is intended for use with DePuy Spine supplemental internal fixation.

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

The proposed modification to the DePuy Cougar® Implant (i.e. increase in lordotic angle) results in a device that is substantially equivalent to the predicates. The footprint of the subject devices remains unchanged from the predicate Cougar devices. The increase in lordotic angle provides the same

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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 Optima material. This material is identical to the predicate devices.

### Performance Data l.

Performance data per ASTM F2077-11, ASTM-F2267-04, and DePuy Spine internal protocols were submitted to characterize the subject Cougar® Implants that are the subject of this PreMarket notification. This testing was comprised of static and dynamic compression testing on the proposed device as well as subsidence and expulsion testing.

### J. Conclusion

DePuy Spine provided Performance Testing to demonstrate that the increase in lordotic angle (1) does not change the intended use of the device and (2) the change in scientific technology (i.e. change in lordotic angle) does not raise new questions of safety and effectiveness. The data presented in this PreMarket Notification demonstrates that the subject devices are as safe and effective as the chosen predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

DEC 1 3 2011

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

Re: K113348

Trade/Device Name: Cougar® Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: November 11, 2011 Received: November 14, 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. Iisting 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

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Page 2 – Mr. Kevin G. Stevens

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/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.

http://www.fda.gov//MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Eunice Keith

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: COUGAR™ System

Indications For Use:

The COUGAR System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation.

The COUGAR System is indicated for use in the thoracolumbar spine (i.e., T1-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. The COUGAR System is also indicated for treating fractures of the thoracic and lumbar spine. The COUGAR 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, the COUGAR System is intended for use with DePuy Spine supplemental internal fixation.

Prescription Use ______________ AND/OR Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(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 Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

· K113348 510(k) Number_