SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)

K024364 · Synthes (Usa) · MQP · Mar 17, 2003 · Orthopedic

Device Facts

• Record ID: K024364
• Device Name: SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
• Applicant: Synthes (Usa)
• Product Code: MQP · Orthopedic
• Decision Date: Mar 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vertebral Spacer Ti System is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Vertebral Spacer Ti can be packed with bone. The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Story

Vertebral Spacer Ti is a titanium implant for vertebral body replacement in the thoracolumbar spine (T1-L5). Used following corpectomy or vertebrectomy to provide anterior spinal column support for tumor or trauma patients. Implant consists of fixed-height, cross-section components; interior may be packed with bone. Requires supplemental internal fixation (e.g., ATLP, VentroFix, USS). Implanted by surgeons using manual surgical instrumentation. Provides structural stability; designed for prolonged support even without fusion.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s' (September 27, 2000).

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295). Form factor: Fixed height and cross-section vertebral body replacement implants. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used 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

• Synthes Vertebral Spacer, Ti (K020152)

Submission Summary (Full Text)

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Ko 2456 Premarket Notification - Vertebral Spacer Ti

## Summary of Safety and Effectiveness Information 3.0

| SPONSOR: | MAR 1 7 2003<br>Synthes Spine Company, L. P.<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Jonathan Gilbert |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes Vertebral Spacer Ti |
| CLASSIFICATION: | Per CFR 21, §888.3060: Implant, fixation, spinal intervertebral<br>body fixation orthosis devices. Class II.<br>Product code is MQP. The Panel code is 87. |
| PREDICATE DEVICE: | Vertebral body replacement device:<br>Synthes Vertebral Spacer, Ti: K020152<br>SE date: April 16, 2002. |
| DEVICE<br>DESCRIPTION: | The Vertebral Spacer Ti is a titanium vertebral body<br>replacement device used in conjunction with supplemental<br>internal fixation to provide structural stability in skeletally<br>mature individuals following corpectomy or vertebrectomy and<br>consists of:<br>vertebral body replacement devices comprised of a variety<br>of fixed heights and cross-sections.supplemental fixation currently cleared for use in treating<br>patients for tumor, trauma or fractures of the vertebral body<br>andmanual surgical instrumentation used to prepare the<br>anatomy and implant the Vertebral Spacer Ti.There are no unique surgical instruments required for<br>implantation of the submitted device system. |
| INTENDED USE: | The Vertebral Spacer Ti is a vertebral body replacement device<br>intended for use in the thoracolumbar spine (T1-L5) to replace<br>a collapsed, damaged, or unstable vertebral body due to tumor<br>or trauma (i.e., fracture). The Vertebral Spacer Ti System is<br>intended to be used with Synthes supplemental internal fixation<br>systems, e.g., ATLP, VentroFix, USS and Small Stature USS.<br>The interior of the spacer component of the Vertebral Spacer Ti<br>can be packed with bone.<br>The Vertebral Spacer Ti is designed to provide anterior spinal<br>column support even in the absence of fusion for a prolonged<br>period. |

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All components of the Vertebral Spacer Ti are manufactured MATERIAL: from commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295).

Mechanical testing in accordance with the "Guidance for PERFORMANCE Industry and FDA Staff, Guidance for Spinal System 510(k)s", DATA: September 27, 2000 was presented.

The Vertebral Spacer Ti implants are similar to the predicate BASIS OF Synthes Vertebral Spacer Ti body replacement device(s), SUBSTANTIAL (K020152) with respect to technical characteristics and EQUIVALENCE: performance. The supplemental fixation devices intended for use with the Vertebral Spacer Ti implants are currently cleared for use in patients with either tumor, trauma or fractures.

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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 three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2003

Mr. Jonathan Gilbert RA Project Manager Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301

Re: K024364

> Trade/Device Name: Synthes Vertebral Spacer Ti Regulatory Number: 21, CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 30, 2002 Received: December 31, 2002

Dear Mr. Gilbert:

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

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Page 2 - Mr. Jonathan Gilbert

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. 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 M. Millenn

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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Page 1 of 1

## 2.0 Indications for Use Statement

510(k) Number (if known):

Synthes Vertebral Spacer Ti Device Name:

## Indications:

The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vertebral Spacer Ti is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the 7i Spacer System can be packed with bone.

The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

for Mark N. Milliken
Division Sign-Off

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

024364 510(k) Number_

Synthes Spine Company, L. P. Vertebral Spacer Ti 510(k)