SSP VERTEBRAL BODY REPLACEMENT

K061578 · Specialty Spine Products, LLC · MQP · Dec 26, 2006 · Orthopedic

Device Facts

• Record ID: K061578
• Device Name: SSP VERTEBRAL BODY REPLACEMENT
• Applicant: Specialty Spine Products, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Dec 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture). The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.

Device Story

Hollow cylindrical implant; provides anterior/middle column support in thoracolumbar spine (T1-L5). Used following vertebral body resection/removal due to tumor or trauma. Features open architecture with circumferential holes and notched ends for stability. Implanted by surgeons; requires supplemental internal fixation (e.g., pedicle screw system) and bone graft. Provides structural support; maintains spinal column integrity; facilitates healing. Designed for prolonged support even without fusion.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Hollow cylinder; 12mm or 14mm diameter; 7mm-13mm height; 1.5mm wall thickness. Features open architecture with circumferential holes and notched superior/inferior margins. Material not specified in text. Standalone implant requiring supplemental fixation. Non-software device.

Indications for Use

Indicated for patients requiring anterior/middle column support in the thoracolumbar spine (T1-L5) following resection or removal of damaged, collapsed, or unstable vertebral bodies due to tumor or trauma (e.g., fracture). Must be used with supplemental internal fixation and bone graft.

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

• SynMesh Spacer System (K003275)
• Blackstone Surgical Titanium Mesh System (K030744)
• Blackstone Surgical Titanium Mesh System Angled End Rings (K032700)

Submission Summary (Full Text)

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SSP Vertebral Body Replacement

# 510(k) Summary

DEC 26 2006

# Specialty Spine Products SSP Vertebral Body Replacement

# ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Specialty Spine Products, LLC |
|----------------------------|---------------------------------|
| | 4121 Tigris Way |
| | Riverside, CA 92503 |
| | Telephone [phone] |
| | Fax [phone] |
| Official Contact: | Angela Carlson |
| Representative/Consultant: | Floyd G. Larson |
| | PaxMed International, LLC |
| | 11234 El Camino Real, Suite 200 |
| | San Diego, CA 92130 |
| | Telephone [phone] |
| | FAX [phone] |

DEVICE NAME

| Classification Name: | Spinal intervertebral body fixation orthosis |
|-------------------------|----------------------------------------------|
| Trade/Proprietary Name: | SSP Vertebral Body Replacement |
| Common Name: | Spinal vertebral body replacement device |

#### ESTABLISHMENT REGISTRATION NUMBER

Specialty Spine Products will submit Establishment Registration to FDA prior to marketing the SSP Vertebral Body Replacement.

#### DEVICE CLASSIFICATION

Spinal vertebral body replacement devices are classified as Class II devices (21 CFR 888.3060). The product code for Spinal intervertebral body fixation orthosis is MQP. This device classification is reviewed by the Orthopedic Branch.

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#### INTENDED USE

The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.

## DEVICE DESCRIPTION

The SSP Vertebral Body Replacement is a hollow cylinder available in either 12 mm or 14 mm diameter, with height ranging from 7 mm to 13 mm in 1 mm increments. The various sizes of these implants accommodate individual patient anatomy and pathology. Wall thickness is approximately 1.5 mm. The wall of the device features an open architecture consisting of one or two rows of circumferential holes (depending on height). The ends are notched circumferentially to form a row of "teeth" along the superior and inferior margins.

# EQUIVALENCE TO MARKETED PRODUCT

Specialty Spine Products, LLC has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the SSP Vertebral Body Replacement is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: the SynMesh Spacer System (K003275) from Synthes, the Blackstone Surgical Titanium Mesh System (K030744) from Blackstone Medical, and the Blackstone Surgical Titanium Mesh System Angled End Rings (K032700), also from Blackstone Medical.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Specialty Spine Products, LLC % Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

DEC 9 6 2006

Re: K061578

Trade/Device Name: SSP Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: June 5, 2006 Received: June 7, 2006

Dear Mr. Larson:

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 (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. Floyd G. Larson

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Houbare Bueckup

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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## Indications for Use

510(k) Number (if known): K061578

Device Name: SSP Vertebral Body Replacement

Indications for Use:

The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 -- L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

-The-Counter Use
(CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bruchun
(Division Sign-Off)(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K061578 Rev 061222 Page 1 of 10

510(k) Number K061578