The BASIS™ anterior cervical plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

The BASIS™ anterior Thoracic and Lumbar plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

When used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS™ components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

Device Description

The BASIS™ Spinal System components included in this submission consist of screws, bolts, nuts and plates as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The BASIS™ Spinal System implant components are made from titanium alloy.

AI/ML Overview

The provided document is a 510(k) premarket notification for the BASISTM Spinal System. This type of regulatory submission establishes substantial equivalence to a legally marketed predicate device, rather than proving device performance through a standalone study with specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

No acceptance criteria or reported device performance are presented. The document focuses on regulatory approval based on equivalence.
No sample size for a test set or data provenance is mentioned.
No information on experts or ground truth establishment is provided for a performance study.
No adjudication method is described.
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is discussed.
No standalone (algorithm only) performance study is mentioned.
No type of ground truth used for a performance study is specified.
No sample size for a training set or how ground truth was established for it is provided.

The document indicates that the BASISTM Spinal System was determined to be "substantially equivalent" to several predicate devices, including:

SYNTHES® Cervical Vertebrae Plates (K792352)
SYNTHES® Spinal Implant System (K802462)
ORION® Anterior Cervical Plate System (K973854)
ZPLATE-ATL™ Anterior Fixation System and ZPLATE-ATL™ Anterior Fixation System ZPLATE-II (K922543 and K990603)
VANTAGE™ Anterior Fixation System Plate (K023797)

The indications for use for the BASISTM Spinal System are the same as those for the predicate devices, covering various spinal conditions such as spinal stenosis, spondylolisthesis, spinal deformities, fracture, pseudarthrosis, tumor resection, and failed previous fusion.

Summary

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MAY 1 2 2005

BASISTM Spinal System Summary of Safety and Effectiveness May 2005

Medtronic Sofamor Danek, Inc. USA Company: I. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Richard W. Treharne, PhD Contact: Senior Vice President Regulatory Affairs
Proposed Proprietary Trade Name: BASIS™ Spinal System II.
Classification Name(s)/Product Code(s): III. Classification Name: Spinal Intervertebral Body Fixation Orthosis (per 21 CFR Section 888.3060) Product Codes: KWQ

Product Description IV.

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.

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Indications V.

BASIS™ Cervical Plates

BASIS™ Thoracic/Lumbar Plates

BASIS™ Components

Substantial Equivalence VI.

Documentation was provided which demonstrated the BASIS™ Spinal System to be substantially equivalent to the following systems: SYNTHES® Cervical Vertebrae Plates

(K792352), SYNTHES® Spinal Implant System (K802462), ORION® Anterior Cervical Plate System (K973854), ZPLATE-ATL™ Anterior Fixation System and ZPLATE-ATL™ Anterior Fixation System ZPLATE-II (K922543 and K990603) and the VANTAGE™ Anterior Fixation System Plate (K023797).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, placed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the upper portion of the circle.

MAY 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051039

Trade/Device Name: BASIS™ Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 22, 2005 Received: April 25, 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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your of substantial equivalence of your device to a legally premits to the time 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 If you desire specific acvies in 1 3 % (240) 276-0120. 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 other general mionnairen val and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stupt Clurdon

A Miriam 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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KOSIO34 CONFIDENTIAl

Page 1 of of 1 l April 2005

510(k) Number (if known):

Device Name: _______________________________________ BASISTM Spinal System

Indications For Use

BASIS™ Cervical Plates

BASIS™ Thoracic/Lumbar Plates

BASIS™ Components

Prescription Use	X
(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)

Hurt Chords
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number ................................................................................................................................................................

000000

(

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Regulation Number and Section

N/A