DEPUY SPINE LATERAL SYSTEM

K090899 · Depuy Spine, Inc. · MAX · May 19, 2009 · Orthopedic

Device Facts

• Record ID: K090899
• Device Name: DEPUY SPINE LATERAL SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The 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 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 contiquous 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

Lateral Cage System; spinal implant for vertebral body replacement (VBR) or intervertebral body fusion. Implants feature open architecture for autograft/allograft packing; available in various heights and lordotic configurations. Used in thoracolumbar spine (T1-L5 for VBR; L2-S1 for fusion). Implanted via open or minimally invasive lateral approach by surgeons. Requires supplemental internal fixation. Restores spinal column height and biomechanical integrity; facilitates fusion in DDD patients. Benefits include decompression of neural tissues and stabilization of spinal segments.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing characterizing the device performance.

Technological Characteristics

Carbon Fiber Reinforced Polymer construction. Open architecture design for bone graft packing. Various heights and lordotic configurations. Implanted via lateral approach. Requires supplemental internal fixation.

Indications for Use

Indicated for skeletally mature patients with thoracolumbar (T1-L5) vertebral body disease (tumors, fractures, collapsed height) or degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with up to Grade 1 spondylolisthesis/retrolisthesis. DDD patients must have 6 months of failed non-operative treatment. Contraindications include skeletal immaturity.

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

• Lateral Cage System (K082128)
• Concorde VBR Spinal System (K041722, K052746)
• Stackable Cage System (K001340, K013382)

Submission Summary (Full Text)

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K090899

# 510(k) Summary SUBMITTER:

DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02780

CONTACT PERSON: Hande Tufan

MAY 19 2009

DATE PREPARED: March 31, 2009

CLASSIFICATION NAME: Spinal Vertebral Body Replacement Device \$888.3060

> Intervertebral Body Fusion Device 888.3080

PROPRIETARY NAME: Lateral Cage System

PREDICATE DEVICES: Lateral Cage System (K082128) Concorde VBR Spinal System (K041722, K052746) Stackable Cage System (K001340, K013382)

DEVICE DESCRIPTION: The Lateral Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of allograft and/or autogenous bone graft (autograft), depending on intended use.

> The Lateral Cage System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The Lateral Cage System is indicated for use in the INTENDED USE: 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 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 contiquous

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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.

### MATERIALS:

Manufactured from Carbon Fiber Reinforced Polymer.

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# PERFORMANCE DATA:

Performance data were submitted to characterize the Lateral 1 Cage System.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAY 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Depuy Spine, Inc. % Ms. Hande Tufan Sr. Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K090899

Trade Name: Lateral Cage System Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MOP Dated: March 31, 2009 Received: April 3, 2009

Dear Ms. Tufan:

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 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 (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.

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Page 2 - Ms. Hande Tufan -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

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 IV.

510(k) Number (if known):

Lateral Cage System Device Name:

Indications For Use:

The 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 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: OR Over-The-Counter Use: (Per 21 CFR 801.109)

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S 88390 1931 1 Concurrence of CDRH, Office of Device Evaluation (ODE

16 09 0899

1999 margist.

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