SYNTHES ORACLE SPACER

K062933 · Synthes Spine Co.Lp · MQP · Jan 31, 2007 · Orthopedic

Device Facts

• Record ID: K062933
• Device Name: SYNTHES ORACLE SPACER
• Applicant: Synthes Spine Co.Lp
• Product Code: MQP · Orthopedic
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oracle Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures for the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Oracle Spacer is intended to be used with Synthes internal fixation systems, e.g., Pangea, USS (including Click'X), Small Stature USS, ATLP, TSLP, and Ventrofix. The interior of the spacer can be packed with bone (autograft or allograft). The Oracle Spacer 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.

Device Story

Radiolucent vertebral body replacement device; used in thoracolumbar spine (T1-L5) following corpectomy; provides structural stability; restores vertebral height; facilitates anterior decompression. Oval-shaped spacer; open architecture for bone graft packing (autograft/allograft); available in various heights, sizes, and lordosis angles. Used in conjunction with supplemental internal fixation systems (e.g., Pangea, USS, ATLP, TSLP, Ventrofix). Implanted by surgeons during spinal procedures; restores biomechanical integrity of spinal column.

Clinical Evidence

Bench testing only; mechanical test data presented in conformance with the 'Guidance for Spinal System 510(k)s' (May 3, 2004).

Technological Characteristics

Radiolucent polymer and titanium alloy materials conforming to ASTM standards. Open architecture design for bone graft packing. Available in various heights, cross-sectional sizes, and lordosis angles. Mechanical device; no software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) following partial or total vertebrectomy due to tumor or trauma (fracture).

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

• Synthes Vertebral Spacer (K011037)
• Interpore Cross Geo™ Structure (K010530)

Submission Summary (Full Text)

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L062933

## 5.0 510 (k) Summary

| JAN 3 1 2007 | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
| 510 (k) Contact: | Bonnie Smith, RAC<br>Synthes Spine Regulatory Affairs |
| Trade Name: | Oracle |
| Common /<br>Classification Name: | Vertebral Body Replacement Device |
| Device Product<br>Code and<br>Classification: | MQP<br>21 CFR 888.3060: Class II |
| Predicate: | K011037 - Synthes Vertebral Spacer<br>K010530 - Interpore Cross Geo™ Structure |
| Device Description: | The Synthes Oracle Spacer is a radiolucent vertebral body replacement<br>device used in conjunction with supplemental fixation that provides<br>structural stability in skeletally mature individuals following partial or<br>total corpectomy.<br><br>The Oracle Spacer has an oval shape and may be used to accommodate<br>the anatomical requirements of the space created by the corpectomy.<br>The spacer has an open architecture for packing bone graft material and<br>it is available in various heights, cross-sectional sizes and lordosis<br>angles to suit individual pathology and anatomical conditions. |
| Intended Use/<br>Indications for Use: | The Oracle Spacer is a vertebral body replacement device intended for<br>use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral<br>body resected or excised during partial and total vertebrectomy<br>procedures for the treatment of tumor or trauma (i.e., fracture), to<br>achieve anterior decompression of the spinal cord and neural tissues,<br>and to restore the height of the collapsed vertebral body. The Oracle<br>Spacer is intended to be used with Synthes internal fixation systems,<br>e.g., Pangea, USS (including Click'X), Small Stature USS, ATLP,<br>TSLP, and Ventrofix. The interior of the spacer can be packed with<br>bone (autograft or allograft).<br>The Oracle Spacer is designed to restore the biomechanical integrity of<br>the anterior, middle, and posterior spinal column even in the absence of<br>fusion for a prolonged period. |
| Substantial<br>Equivalence: | Documentation has been provided that demonstrates that the Synthes<br>Oracle Spacer is substantially equivalent to the previously cleared<br>Synthes Vertebral Spacer (K011037) and the Interpore Cross Geo™<br>Structure (K010530). |
| Material: | Radiolucent polymer and titanium alloy materials in conformance with<br>ASTM Standards. |
| Performance Data: | Mechanical test data is presented in conformance with the “Guidance<br>for Spinal System 510(k)s”, issued May 3, 2004. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 logo is black and white and appears to be a simple, clean design. The eagle is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SYNTHES Spine Co., L.P. % Ms. Bonnie Smith, RAC Regulatory Affairs Project Manager 1302 Wrights Lane East West Chester, Pennsylvania 19380

JAN 3 1 2007

Re: K062933

Trade/Device Name: Synthes Oracle Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 8, 2006 Received: December 11, 2006

Dear Ms. Smith:

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 - Ms. Bonnie Smith, 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/industry/support/index.html.

Sincerely yours.

Sarbare Boucher

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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## 4.0 Indications for Use Statement

510(k) Number (if known):

Device Name: Oracle Spacer

Indications for Use:

The Oracle Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures for the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Oracle Spacer is intended to be used with Synthes internal fixation systems, e.g., Pangea, USS (including Click'X), Small Stature USS, ATLP, TSLP, and Ventrofix. The interior of the spacer can be packed with bone (autograft or allograft).

K062933

The Oracle Spacer 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.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE).

AND/OR

Barbara Buettner

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K062933

000015 1 of 1

Synthes Spine Co., L.P. Oracle Spacer 510(k)

CONFIDENTIAL