COUGAR® LS Lateral Cage System and COUGAR® System

K162327 · Medos International SARL · MAX · Dec 12, 2016 · Orthopedic

Device Facts

• Record ID: K162327
• Device Name: COUGAR® LS Lateral Cage System and COUGAR® System
• Applicant: Medos International SARL
• Product Code: MAX · Orthopedic
• Decision Date: Dec 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

COUGAR® LS Lateral Cage System: The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine (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 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 from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. Additionally, the COUGAR LS Lateral Cage System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be sketally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and may be implanted via an open or a minimally invasive lateral approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When use as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation. COUGAR® System: The COUGAR System is indicated for use as 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). Additionally the COUGAR System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products. 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 tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Spine supplemental internal fixation products.

Device Story

COUGAR and COUGAR LS Lateral Cage Systems are intervertebral body fusion and vertebral body replacement devices; constructed from carbon fiber reinforced PEEK (CFRP) with tantalum x-ray markers; available in parallel or lordotic configurations. Implants feature teeth to resist migration/rotation and cavities for bone graft packing. COUGAR LS implanted via open or minimally invasive lateral approach; COUGAR implants via anterior approach. Used in clinical settings by surgeons to restore spinal column biomechanical integrity, facilitate fusion, or replace diseased/collapsed vertebral bodies. Requires use with DePuy Spine supplemental internal fixation. Output is structural support for spinal column; aids clinical decision-making by providing stability for fusion or reconstruction; benefits patients by restoring height and spinal integrity.

Clinical Evidence

No new clinical testing performed. Evidence consists of a literature analysis of published clinical data demonstrating that lumbar interbody fusion devices similar to the subject systems are as safe and effective as predicates for the indicated uses.

Technological Characteristics

Materials: Carbon Fiber Reinforced PEEK-OPTIMA LT1 Compound (CFRP); Tantalum x-ray markers (ASTM F-560). Configuration: Parallel or lordotic cages with teeth and graft cavities. Energy: None (mechanical implant). Connectivity: N/A.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain, confirmed by history/radiography) at 1-2 contiguous lumbar levels (L2-S1), potentially with Grade I spondylolisthesis/retrolisthesis; patients with spinal deformities requiring fusion (after 6 months non-operative treatment); patients requiring vertebral body replacement for tumors or fractures (T1-L5).

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

• K140759
• COUGAR (K081917)
• COUGAR (K113348)
• COUGAR LS Lateral Cage System (K082128)
• COUGAR LS Lateral Cage System (K110454)
• COUGAR LS Lateral Cage System (K122896)
• Concorde Bullet Lumbar Interbody System (K151773)
• Medtronic CAPSTONE Spinal System (K123027)
• NuVasive CoRoent Lumbar System (K151472)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

December 12, 2016

Medos International, Sarl % Mr. Eric Zhu Regulatory Affairs Specialist DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K162327

Trade/Device Name: COUGAR® LS Lateral Cage System, COUGAR® System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, MQP Dated: November 9, 2016 Received: November 10, 2016

Dear Mr. Eric Zhu:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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/ResourcesforYou/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,

## Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K162327

#### Device Name

COUGAR® LS Lateral Cage System and COUGAR® System

Indications for Use (Describe) COUGAR® LS Lateral Cage System:

The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine (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 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 from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the COUGAR LS Lateral Cage System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be sketally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and may be implanted via an open or a minimally invasive lateral approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When use as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

## COUGAR® System:

The COUGAR System is indicated for use as 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). Additionally the COUGAR System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products.

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 tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Spine supplemental internal fixation products.

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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Medos International. The logo consists of a red caduceus symbol on the left, followed by the word "medos" in black, and the word "international" in gray. There is a gray line underneath the words.

## 510(k) SUMMARY

#### Submitter Information A.

| Manufacturer: | Medos International Sárl<br>Chemin-Blanc 38<br>2400 Le Locle, Switzerland |
|---------------|---------------------------------------------------------------------------|
|---------------|---------------------------------------------------------------------------|

| Submitter: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 |
|------------|---------------------------------------------------------------|
|------------|---------------------------------------------------------------|

| Contact Person: | Eric Zhu |
|-------------------|---------------------|
| Address: | 325 Paramount Drive |
| | Raynham, MA 02767 |
| Telephone number: | [phone] |
| Fax number: | [phone] |
| Email: | [e-mail] |

B. Date Prepared

#### C. Device Name

| Trade/Proprietary Name: | COUGAR® LS Lateral Cage System<br>COUGAR® System |
|--------------------------------|------------------------------------------------------------------------------------|
| Common/Usual Name: | Intervertebral Body Fusion Device;<br>Spinal Intervertebral Body Fixation Orthosis |
| Classification and Regulation: | Class II per 21 CFR 888.3080 |

August 17, 2016

Classification Product and Panel Code:

MAX, MQP; Orthopedic

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Medos International. The logo consists of a red caduceus symbol on the left, followed by the word "medos" in black bold font and the word "international" in gray font. A thin gray line runs underneath the text.

#### D. Predicate Device Name

The subject devices are substantially equivalent to the primary predicate devices cleared under K140759, and the following additional predicate devices: COUGAR® (K081917, K113348), COUGAR® LS Lateral Cage System (K082128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K151773), Medtronic CAPSTONE® Spinal System (K123027) and NuVasive CoRoent® Lumbar System (K151472).

#### Device Description E.

The COUGAR and COUGAR LS Lateral Cage Systems consists of 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 cage structure is radiolucent with tantalum x-ray markers 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 bone graft material. The COUGAR LS Lateral Cage System may be implanted via an open or a minimally invasive lateral approach. The COUGAR implants are placed via an anterior approach.

#### Indications for Use F.

## COUGAR LS Lateral Cage System:

The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine(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 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 from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the Cougar LS Lateral Cage System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and may be implanted via an open or a minimally invasive lateral approach using autogenous bone and/or allogenic bone graft

{6}------------------------------------------------

# s interr

comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

## COUGAR System:

The COUGAR System is indicated for use as 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). Additionally the COUGAR System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products.

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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Spine supplemental internal fixation products.

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

The technological characteristics of the subject devices remain unchanged from their currently marketed predicate versions in their design, material, performance, and intended use.

#### H. Materials

The materials of the subject devices remain unchanged from the currently marketed predicate devices. Both the COUGAR and COUGAR-LS Lateral Cage implants are manufactured from Carbon Fiber Reinforced PEEK-OPTIMA LT1 Compound (CFRP) with tantalum x-ray markers that conform to ASTM F-560.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Medos International. The word "medos" is in black font, while "international" is in gray font. There is a red medical symbol to the left of the word "medos". A gray line is underneath the entire logo.

#### I. Performance Data

A literature analysis of published clinical data is provided to support the modified Indications for Use. The clinical and radiographic outcomes demonstrate that lumbar interbody fusion devices similar to the COUGAR and COUGAR LS Lateral Cage System are as safe and effective as the predicate devices for the modified Indications for Use. No additional testing was required as there were no changes to the technological characteristics of the Subject Cage Systems.

#### J. Conclusion

Based on the technological characteristics, comparison to predicate devices and clinical performance data from the clinical literature, the subject COUGAR and COUGAR LS Lateral Cage Systems are as safe and as effective as the predicate devices due to similar intended use and technological characteristics.