EBI CAS SPINE SPACER SYSTEM

K042268 · Ebi, L.P. · MQP · Oct 27, 2004 · Orthopedic

Device Facts

• Record ID: K042268
• Device Name: EBI CAS SPINE SPACER SYSTEM
• Applicant: Ebi, L.P.
• Product Code: MQP · Orthopedic
• Decision Date: Oct 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI CAS Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI CAS Spine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System, EBI Spinal System, or the EBI Array Spinal System.

Device Story

Vertebral body replacement device; curved implant design; pyramidal teeth on superior/inferior ends for expulsion resistance; available in flat or lordotic angles. Device features transverse plane opening for bone graft packing; anterior-posterior holes for bone ingrowth. Used in thoracolumbar spine (T1-L5) for tumor resection or fracture treatment; restores biomechanical integrity of spinal column. Requires concurrent use with EBI NGC, Omega 21, SpineLink II, or Array Spinal Systems as supplemental internal fixation. Implanted by surgeons in clinical/OR settings.

Clinical Evidence

Bench testing only. Mechanical testing compared the EBI CAS Spine Spacer System to predicate systems to demonstrate compliance with functional requirements and applicable standards.

Technological Characteristics

Material: Titanium, Ti-6Al-4V ELI (ASTM F136). Form factor: Curved vertebral body replacement implant with pyramidal teeth. Features: Transverse opening for bone graft, anterior-posterior holes for bone growth. Configuration: Flat or lordotic angles. Supplemental fixation required via external spinal systems.

Indications for Use

Indicated for patients requiring partial vertebrectomy in the thoracolumbar spine (T1-L5) due to tumors or thoracic/lumbar fractures. Used to achieve anterior decompression and restore vertebral body height. Must be used with specified EBI spinal fixation systems.

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

• EBI ESL Spine Spacer System (K040482)
• EBI Ionic Spine Spacer System (K020887)

Submission Summary (Full Text)

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1042268

# OCT 2 7 2004

## 510(k) Summary

This 510(k) Summary for the EBI AIS System is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

- 1. Submitter: Frederic Testa, RAC Regulatory Affairs Project Manager EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Frederic Testa, RAC Telephone: [phone] Fax: [phone]

Date prepared: August 13, 2004

| 2. Proprietary Name: | EBI CAS Spine Spacer System |
|---------------------------|----------------------------------------------|
| Common Name: | Spinal Fixation Device |
| Classification Name/Code: | Spinal Vertebral Body Replacement Device/MQP |

### 3. Predicate or legally marketed devices that are substantially equivalent:

- · EBI ESL Spine Spacer System (K040482)
- · EBI Ionic Spine Spacer System (K020887)
- 4. Description of the device: The CAS Spine Spacer System is design modification of the EBI ESL Spine Spacer System. The EBI CAS Spine System is a vertebral body replacement device consisting of one curved implant. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for more bone growth through the device. The EBI CAS Spine Spacer System is intended for use with the EBI NGC Spinal System, the EBI Omega21™ Spinal System, EBI SpineLink™ II Spinal System, or the EBI Array Spinal System as a supplemental internal fixation system.
- 5. Intended Use: The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI CAS Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI CAS Spine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System, EBI Spinal System, or the EBI Array Spinal System.
- 6. Materials: The CAS Spine Spacer System is manufactured from Titanium, Ti-6Al-4V ELI, per ASTM F136.

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- 7. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI CAS Spine Spacer System and other currently marketed spine systems. The EBI CAS Spine Spacer System is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Mechanical testing comparing the EBI ESL Spine Spacer System to a predicate system demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements.
* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

**MAN SERVICE**

Public Health Service

OCT 2 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederick Testa, RAC Regulatory Affairs Project Manager EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K042268

Trade/Device Name: EBI CAS Spine Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: September 28, 2004 Received: September 29, 2004

Dear Mr. Testa:

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 for abound in 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. Frederick Testa, RAC

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/dsma/dsmamain.html

Sincerely yours,

Mark A Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K0402268

Device Name: EBI CAS Spine Spacer System

Indications For Use:

The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., The LDI CAS Spille Dpacer Bystem partial vertebrectomy) of a diseased vertebral body 11- L.) 101 partial replacement (10), for promote to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral of the spinar cord and nearly asser System is also indicated for treating fractures of the body. The EDI CHO Upme Spacer System Spacer System is designed to restore the thoracic and fulliour spine. "The anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The system must be used in absence of railer for a pNGC Spinal System, EBI Omega 21 Spinal System, EBI SpineLink II Spinal System, or the EBI Array Spinal System.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mullison

Division of General, Restorative, and Neurological Devices

K042268
**510(k) Number**