BASIS VERTEBRAL BODY SPACER

K051105 · Medtronic Sofamor Danek · MQP · Jun 9, 2005 · Orthopedic

Device Facts

• Record ID: K051105
• Device Name: BASIS VERTEBRAL BODY SPACER
• Applicant: Medtronic Sofamor Danek
• Product Code: MQP · Orthopedic
• Decision Date: Jun 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Additionally, BASIS™ Vertebral Body Spacers are intended to be used with bone graft.

Device Story

BASIS™ Spinal System consists of titanium alloy vertebral body spacers and ancillary instruments. Used in partial corpectomy procedures to replace and restore height of resected vertebral bodies in the thoracolumbar spine (T1-L5). Implanted by surgeons during spinal stabilization procedures. Requires supplemental anterior/posterior fixation and bone graft to augment stability. Provides structural support to the spine following excision of bone due to tumor or trauma.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy. Form factor: Vertebral body spacers of various lengths and widths. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring partial corpectomy in the thoracolumbar spine (T1-L5) for treatment of tumor or trauma (fracture). Must be used with supplemental 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

• HOURGLASS™ VBS (K033926)

Submission Summary (Full Text)

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## BASISTM Spinal System -- Vertebral Body Spacers Summary of Safety and Effectiveness May 2005

- I. Company: Medtronic Sofamor Danek, Inc. USA 1800 Pyramid Place Memphis, TN 38132 [phone]
Contact: Richard W. Treharne, PhD Senior Vice President Regulatory Affairs

- Proposed Proprietary Trade Name: BASIS™ Spinal System II.
- III. Classification Name(s)/Product Code(s): Classification Name: Spinal Intervertebral Body Fixation Orthosis (per 21 CFR Section 888.3060) Product Codes: MQP

#### IV. Product Description

The BASIS™ Spinal System components included in this submission consist of various lengths and widths of vertebral body spacers as well as ancillary instrument sets. The BASIS™ Device is a spacer that inserts between vertebral bodies in the anterior thoracic and lumbar spine.

The BASIS™ Spinal System implant components are made from titanium alloy. No warranties express, or implied are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct.

BASIS™ Vertebral Body Spacers must be used with additional anterior and/or posterior spinal instrumentation to augment stability.

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#### V. Indications

When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Additionally, BASIS™ Vertebral Body Spacers are intended to be used with bone graft.

#### Substantial Equivalence VI.

Documentation was provided which demonstrated the BASIS™ Spinal System to be substantially equivalent to the following systems: HOURGLASS™ VBS (K033926).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol resembling a caduceus, with three lines representing the branches of government and a wavy line at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 9 - 2005

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K051105

Trade/Device Name: BASIS M Spinal System - Vertebral Body Spacers Regulation Number: 21 CFR 888 3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 24, 2005 Received: May 31, 2005

Dear Dr. Treharne:

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 10 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 - Richard W. Treharne, Ph.D.

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,

Miriam C. Provost, Ph.D.

Acting 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_ April 2005

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use

When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-LS) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.c., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Additionally, BASIS™ Vertebral Body Spacers are intended to be used with bone graft.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hyatt Clurder

(Division Sign-1 Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

COUSS

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