LDR SPINE ROI-C IMPLANT

K080728 · Ldr Spine USA · MQP · May 29, 2008 · Orthopedic

Device Facts

• Record ID: K080728
• Device Name: LDR SPINE ROI-C IMPLANT
• Applicant: Ldr Spine USA
• Product Code: MQP · Orthopedic
• Decision Date: May 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ROI-C 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-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.

Device Story

ROI-C system consists of D-shaped implants in various heights and dimensions; manufactured from radiolucent PEEK; features closed graft space and surface teeth for stability; compatible with titanium anchors. Used by surgeons in clinical settings for partial vertebral body replacement in thoracolumbar spine (T1-L5). Implants are placed in pairs; requires supplemental internal fixation. Provides structural support to replace resected/excised vertebral bodies; aids in spinal stabilization.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: PEEK (radiolucent) and titanium (anchors). Form factor: D-shaped blocks with surface teeth. Connectivity: None. Energy source: None. Sterilization: Not specified.

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. Must be used in pairs with 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 MC+ Partial Vertebral Body Replacement System (K043479)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for "LDR" with the tagline "a passion for innovation" underneath. The logo consists of a stylized eye-like graphic to the left of the letters "LDR", which are in a bold, sans-serif font. The tagline is in a smaller, lighter font and is centered below the "LDR" letters.

MAY 2 9 2008

## 510(k) Summary

### LDR Spine USA ROI-C Partial Vertebral Body Replacement System

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

### 3. Date 510(k) Summary Prepared

March 12, 2008

| 4. Trade Name | LDR Spine ROI-C System |
|----------------|--------------------------------------------------------------------------------|
| Common Name | Spinal Partial Vertebral Body Replacement Device |
| Classification | MQP<br>Spinal Intervertebral Body Fixation Orthosis – Class II<br>per 888.3060 |

# 5. Legally Marketed Equivalent Predicate Device

LDR Spine MC+ Partial Vertebrai Body Replacement System (K043479)

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Image /page/1/Picture/1 description: The image shows the logo for LDR, which includes a stylized eye graphic to the left of the letters "LDR" in bold, black font. Below the logo, the text "a passion for innovation" is written in a smaller, lighter font. The logo appears to be for a company or organization that values innovation and has a focus on vision or insight, as suggested by the eye graphic.

## 6. Device Description

The ROI-C Implants are D-shaped blocks in a variety of heights and length x width combinations. The ROI-C implants feature a closed graft space and the inferior and superior surface of the devices have a pattern of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchors available for use with the ROI-C system.

## 7. Intended Use of the device

The ROI-C 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-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.

### 8. Non-Clinical Performance Data

Results of the non-clinical analysis and verification activities indicate that the ROI-C system is substantially equivalent to the predicate device 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 its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LSR Spine USA, Incoporated % Mr. Noah Bartsch Manager, Clinical, Regulatory & Quality Affairs 4030 West Braker Lane, Suite 360 Austin, Texas 78759

Re: K080728 Trade/Device Name: LDR Spine ROI-C Implant Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: Class II Product Code: MQP Dated: May 2, 2008 Received: May 5, 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.

MAY 2 9 2008

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 (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

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 M. Mulhearn

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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K080728
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## Indications for Use Statement

Page 1 of 1

510(k) Number (if known): K080728

Device Name: LDR Spine ROI-C Implant

Indications for Use:

The ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to turnor 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-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.

Prescription Use _ X (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)

Neil R. Ogden for mkm

Division of Gener and Neurological Devices

510(k) Number K080728