MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM

K090507 · Ldr Spine USA · MAX · Jun 25, 2009 · Orthopedic

Device Facts

• Record ID: K090507
• Device Name: MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM
• Applicant: Ldr Spine USA
• Product Code: MAX · Orthopedic
• Decision Date: Jun 25, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. When used as a vertebral body replacement device, The ROI System of implants is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone. The ROI-A implants are intended to be implanted singularly.

Device Story

ROI-A Implant System consists of interbody fusion and partial vertebral body replacement implants; designed for lumbar spine fusion or thoracolumbar vertebral body replacement. Implants are placed surgically by a physician; used with supplemental internal fixation and bone graft (autograft/allograft) to facilitate fusion. Device provides structural support to the spinal column following disc degeneration, tumor resection, or trauma. Benefits include stabilization of the spinal segment and promotion of fusion. System is intended for singular implantation.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical (laboratory) validation testing.

Technological Characteristics

Intervertebral body fusion and vertebral body replacement system. Materials, processing, and packaging are identical to the predicate. Designed for use with supplemental internal fixation. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring lumbar intervertebral body fusion (L2-S1) for degenerative disc disease with up to Grade I spondylolisthesis after 6 months of failed non-operative treatment, or for partial vertebral body replacement in the thoracolumbar spine (T1-L5) following resection due to tumor or trauma/fracture. Requires supplemental internal fixation and use of autograft or allograft bone.

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

• ROI-A Implant System (K090507)

Submission Summary (Full Text)

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K090507

JUN 2 5 2009

## LDR Spine ROI Interbody Fusion System ROI-A Implant System

## 510(k) Summary of Safety and Effectiveness

#### SUBMITTED BY

LDR Spine USA 4030 W. Braker Lane, Suite 360 Austin, TX 78759

#### FOREIGN ESTABLISHMENT REGISTRATION NUMBER

3004788213

## US AGENT ESTABLISHMENT REGISTRATION NUMBER

3004903783

## CONTACT PERSON

Noah Bartsch Manager, Clinical, Regulatory and Quality Affairs Phone: [phone] Fax: [phone]

#### DATE PREPARED

February 24, 2009

CLASSIFICATION NAME

MAX 888.3080- Intervertebral Fusion Device with Bone Graft, Lumbar MQP 888,3060 - Spinal Intervertebral Body Fixation Orthosis

#### COMMON NAME

Intervertebral Body Fusion Device (MAX) Spinal Vertebral Body Replacement Device (MQP)

## PROPRIETARY NAME

LDR Spine ROI Interbody Fusion System ROI-A Implant System

## DEVICE DESCRIPTION

The ROI-A System is part of the ROI Interbody Fusion System family, and is comprised of various sizes and configurations of implants to accommodate individual patient anatomy. The ROI-A is intended to be used for interbody fusion of the lumbar spine, and is also indicated for use as a partial vertebral body replacement of the thoraco-lumbar spine.

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#### INDICATIONS:

When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device. The ROI System of implants is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

The ROI-A implants are intended to be implanted singularly.

## COMPARISON TO THE PREDICATE:

Minor design modifications were made to the Predicate ROI-A System, resulting in the Proposed device design. The Predicate and Proposed devices have the identical intended uses, indications, materials of manufacture, processing, packaging, and surgical technique.

#### PERFORMANCE DATA:

Clinical performance data was not required to support this submission.

The results of non-clinical (laboratory) validation testing demonstrate that the proposed design changes provide reasonable assurance of safety and effectiveness.

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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) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

Public Health Service

JUN 25 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LDR Spine USA % Noah Bartsch, M.S., R.A.C. 4030 W. Braker Lane, Suite 360 Austin, TX 78759

Re: K090507

Trade/Device Name: LDR Spine ROI Interbody Fusion System; ROI-A Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, MQP Dated: May 22, 2009 Received: May 26, 2009

Dear Mr. Bartsch:

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.

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 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.

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Page 2 - Mr. Noah Bartsch, M.S., R.A.C.

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,
Mark A. Milliken

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: LDR Spine RQI Interbody Fusion System - ROI-A Implant System

#### Indications for Use:

When used as an intervertebral body fusion device, the RO! Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device, The RO! System of implants is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

The implants are intended to be implanted singularly (for ROI-A).

| Prescription Use | AND/OR | Over-The-Counter Use |
|----------------------------------|--------|------------------------|
| X<br>(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)

-バ (EXT for MXM) 6/24109

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

510(k) Number_ K090507