LDR SPINE ROI INTERBODY FUSION SYSTEM

K082262 · Ldr Spine USA · MAX · Feb 2, 2009 · Orthopedic

Device Facts

• Record ID: K082262
• Device Name: LDR SPINE ROI INTERBODY FUSION SYSTEM
• Applicant: Ldr Spine USA
• Product Code: MAX · Orthopedic
• Decision Date: Feb 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 while the ROI-T implants may be implanted singularly or in pairs.

Device Story

ROI Interbody Fusion System consists of spinal implants for intervertebral fusion or partial vertebral body replacement. Configurations include ROI-T (transforaminal) and ROI-A (anterior) approaches. Implants are placed surgically by a physician; ROI-A used singularly; ROI-T used singularly or in pairs. System requires supplemental internal fixation and use of autograft or allograft bone to facilitate fusion. Device provides structural support to the spine to stabilize segments or replace resected vertebral bodies, aiming to alleviate pain and restore spinal stability in patients with degenerative disc disease, tumors, or traumatic fractures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Spinal interbody fusion and vertebral body replacement implants; available in two configurations (ROI-T and ROI-A) for different surgical approaches; requires supplemental internal fixation; intended for use with autograft or allograft bone.

Indications for Use

Indicated for skeletally mature patients with lumbar DDD (L2-S1) with up to Grade I spondylolisthesis after 6 months of failed non-operative treatment, or for partial vertebral body replacement (T1-L5) following resection/excision due to tumor or trauma/fracture.

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.

Submission Summary (Full Text)

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

K82a262

ea

FEB -2 2009

### LDR Spine ROI Interbody Fusion System

### 510(k) Summary of Safety and Effectiveness

| SUBMITTED BY | LDR Spine USA<br>4030 W. Braker Lane, Suite 360<br>Austin, TX 78759 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| FOREIGN ESTABLISHMENT<br>REGISTRATION NUMBER | 3004788213 |
| US AGENT ESTABLISHMENT<br>REGISTRATION NUMBER | 3004903783 |
| CONTACT PERSON | Noah Bartsch<br>Manager, Clinical, Regulatory and Quality Affairs<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED | December 2, 2008 |
| CLASSIFICATION NAME | MAX 888.3080- Intervertebral Fusion Device with<br>Bone Graft, Lumbar<br>MQP 888.3060 - Spinal Intervertebral Body Fixation<br>Orthosis |
| COMMON NAME | Intervertebral Body Fusion Device (MAX)<br>Spinal Vertebral Body Replacement Device (MQP) |
| PROPRIETARY NAME | LDR Spine ROI Interbody Fusion System |

#### DEVICE DESCRIPTION

The proposed ROI: Interbody Fusion System will be offered in two: (2) configurations of various sizes. The configurations are designed based on surgical approach, and consist of: 1) ROI-T, transforaminal approach and-2) ROI-A, antentor approach.

#### INDICATIONS:

When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the tumbar spine, from 1,2 to St, 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 discodisease (DDD) with up to Grade I spandyklisthesis: DDD is defined es back pain of discogenic origin with degeneration of the disc confirmed by history and rediographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

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

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 turnor of trauma/fracture: The device is intended for use as a partial vertebral body: replacement in the thoracolumbar spine (from 74 to 15) 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 bane.

The ROI-A implants are intended to be implanted singularly while the ROF-T implantsmay be implanted singularly or in pairs.

# MECHANICAL TEST DATA

.

.

Mechanicalitest results demonstrate that the proposed RQI: Interbody Fusion System is substantially equivalent to the predicate device ..

. ਕੁਹ

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

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

SEP 12 2011

LDR Spine USA % Mr. Noah Bartsch Manager, Clinical, Regulatory and Quality Affairs 4030 W. Braker Lane, Suite 360 Austin, Texas 78759

Re: K082262

> Trade/Device Name: LDR Spine ROI Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX, MQP Dated: December 2, 2008 Received: December 4, 2008

Dear Mr. Bartsch:

This letter corrects our substantially equivalent letter of February 2, 2009.

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 (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

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

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,
Mark N. Mulkern

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

Enclosure

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

## INDICATIONS FOR USE

# 510(k) Number (if known): K082262

Device Name:

LDR Spine RO! Interbody Fusion System

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 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 while the ROI-T implants may be implanted singularly or in pairs.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

71

(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 General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K082262 |