SYNTHES VERTEBRAL SPACER TI

K020152 · Synthes (Usa) · MQP · Apr 16, 2002 · Orthopedic

Device Facts

• Record ID: K020152
• Device Name: SYNTHES VERTEBRAL SPACER TI
• Applicant: Synthes (Usa)
• Product Code: MQP · Orthopedic
• Decision Date: Apr 16, 2002
• 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 Ti Spacer 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 vertebral body replacement implant; used in thoracolumbar spine (T1-L5) following corpectomy or vertebrectomy. Device provides anterior spinal column support for collapsed, damaged, or unstable vertebrae due to tumor or trauma. Implanted by surgeons in clinical settings; requires supplemental internal fixation (e.g., ATLP, VentroFix, USS). Interior may be packed with bone graft. Device provides structural stability; designed to support spine even without fusion. Manual surgical instrumentation used for preparation and implantation.

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). No clinical data presented.

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295). Form factor: Fixed heights and cross-sections. Energy source: None (mechanical implant). 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 SynMesh System (K003275)

Submission Summary (Full Text)

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# APR 1 6 2002

Premarket Notification - Vertebral Spacer Ti

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#### 3.0 Summary of Safety and Effectiveness Information

SPONSOR:

Synthes Spine Company, L. P. 1690 Russell Road Paoli, PA 19301 [phone] Contact: Jonathan Gilbert

DEVICE NAME: Synthes Vertebral Spacer Ti

CLASSIFICATION: Per CFR 21, §888.3060: Implant, fixation, spinal intervertebral body fixation orthosis devices. Class II. Product code is MQP. The Panel code is 87.

PREDICATE DEVICE:

Vertebral body replacement device: Synthes SynMesh System: K003275 SE date: April 23, 2001.

DEVICE DESCRIPTION: The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy and consists of:

- vertebral body replacement devices comprised of a variety . of fixed heights and cross-sections.
- supplemental fixation currently cleared for use in treating . patients for tumor, trauma or fractures of the vertebral body and
- manual surgical instrumentation used to prepare the . anatomy and implant the Vertebral Spacer Ti.

There are no unique surgical instruments required for implantation of the submitted device system.

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 turnor or trauma (i.e., fracture). The Ti Spacer 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.

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Premarket Notification - Vertebral Spacer Ti

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MATERIAL:

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

PERFORMANCE DATA:

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

BASIS OF SUBSTANTIAL EQUIVALENCE: The Vertebral Spacer Ti implants are similar to the predicate Synthes SynMesh vertebral body replacement device(s), (K003275) with respect to technical characteristics and 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administrațion 9200 Corporate Boulevard Rockville MD 20850

Jonathan Gilbert Regulatory Affairs Project Manager Synthes Spine 1690 Russell Road Paoli, Pennsylvania 19301

APR 1 6 2002

Re: K020152

> Trade Name: Vertebral Spacer Ti Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral Body Replacement Regulatory Class: II Product Code: MQP Dated: January 16, 2002 Received: January 17, 2002

Dear Mr. Gilbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Mr. Jonathan Gilbert

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and it your dine of substantial equivalence of your device to a legally marketed predication: "The PDF monty of its a classification for your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

for Mark A. Mellers

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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#### Indications for Use Statement 2.0

Page 1 of 1

510(k) Number (if known):

K020152

Device Name:

Synthes Vertebral Spacer Ti

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

510(k) Number ***_***_ K020152