LDR SPINE ROI-A IMPLANT

K080572 · Ldr Spine USA · MQP · Apr 7, 2008 · Orthopedic

Device Facts

• Record ID: K080572
• Device Name: LDR SPINE ROI-A IMPLANT
• Applicant: Ldr Spine USA
• Product Code: MQP · Orthopedic
• Decision Date: Apr 7, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ROI-A 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. The ROI-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.

Device Story

Cylinder-shaped implant for partial vertebral body replacement; features closed graft space and surface teeth for stability; includes two-part anchoring plate. Implanted surgically in thoracolumbar spine (T1-L5) to replace bone removed due to tumor or trauma. Requires supplemental internal fixation. Provides structural support to spine; inhibits movement via surface teeth and anchoring plate.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cylinder-shaped implant with lordosis angles; features surface teeth for stability and two-part anchoring plate. Mechanical performance verified via bench testing.

Indications for Use

Indicated for patients requiring partial vertebral body replacement in the thoracolumbar spine (T1-L5) following resection or excision due to tumor or trauma/fracture. Requires supplemental internal fixation.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• LDR Spine ROI System (K043349)
• LDR Spine MC+ System (K043479)

Submission Summary (Full Text)

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K080572
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a pession for innovation

APR - 7 2008

510(k) Summary LDR Spine ROI-A Implant

#### 1. Owner's Name & Address

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

Phone: [phone] Fax: [phone]

#### 2. Contact Person

#### Noah Bartsch, MS, RAC

Manager, Clinical, Regulatory & Quality Affairs LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: [phone] Fax: [phone] Email: [e-mail]

## 3. Date 510(k) Summary Prepared: February 27, 2008

- 4. Trade Name: LDR Spine ROI-A Implant Common Name: Spinal Partial Vertebral Body Replacement Device Classification: MQP: Spinal Intervertebral Body Fixation Orthosis - Class II per 888.3060
#### 5. Legally Marketed Equivalent Predicate Device: LDR Spine ROI System (K043349) LDR Spine MC+ System (K043479)

#### 6. Device Description

The ROI-A implants are cylinder shaped blocks in a variety of footprints, heights and lordosis angles.

The ROI-A implants feature a closed graft space. The inferior and superior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. An anchoring plate in two parts is associated to the device to further enhance its stability.

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K080572
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### 7. Intended Use of the device

The ROI-A is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. 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. The ROI-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.

#### 8. Non-Clinical Performance Data

Mechanical test results demonstrate that the proposed ROI-A Implant is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR - 7 2008

LDR Spine USA, Incorporated c/o Mr. Noah Bartsch Manager of Clinical, Regulatory, and Quality Affairs 4030 West Braker Lane, Suite 360 Austin, TX 78759

Re: K080572

> Trade/Device Name: ROI-A Partial Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: March 28, 2008 Received: March 31, 2008

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 such 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); 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 - Mr. Noah Bartsch

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millman

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

Enclosure

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K080572
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## Indications for Use Statement

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1080592 510(k) Number (if known):

Device Name: LDR Spine ROI-A Implant

Indications for Use:

The ROI-A Implant 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. The ROI-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.

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

Over-The-Counter Use (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)

Nirl R.S. Qal firmen

Division of General, Restorative, and Neurological Devices

**510(k) Number** K080572