GLAXY 3.2 SPINAL SYSTEM

K043020 · Medtronic Sofamor Danek · KWP · Jan 7, 2005 · Orthopedic

Device Facts

• Record ID: K043020
• Device Name: GLAXY 3.2 SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWP · Orthopedic
• Decision Date: Jan 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GALAXY™ 3.2 Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, cervical and/or sacral spine. The GALAXY™ 3.2 Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the GALAXY™ 3.2 Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Device Story

GALAXY™ 3.2 Spinal System is a posterior spinal interlaminal fixation orthosis; consists of titanium/titanium alloy screws, hooks, rods, and connectors. Surgeon-assembled construct; tailor-made for individual patient anatomy; provides immobilization and stabilization as adjunct to spinal fusion. Used in thoracic, lumbar, cervical, and sacral spine. Compatible with other Medtronic spinal systems (TSRH®, CD HORIZON®, DYNALOK™, VERTEX™) and ATLAS™ cable. Operates via rigid locking of components to rods. Intended for prescription use by surgeons in clinical settings to treat degenerative conditions, trauma, and tumors.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and intended use compared to predicate device.

Technological Characteristics

Materials: medical grade titanium or titanium alloy. Components: screws, hooks, rods, connectors. Configuration: modular, rigid locking. Connectivity: compatible with existing Medtronic spinal systems via rod connectors. Sterilization: not specified. Energy source: none (mechanical).

Indications for Use

Indicated for patients requiring fusion of cervical and thoracic spine (C1-T3) for DDD (discogenic neck pain), spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, or tumors. Hooks/rods indicated for stabilization following reduction of fracture/dislocation or trauma in cervical/upper thoracic spine. Screws limited to T1-T3 thoracic conditions; not for posterior cervical spine.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• VERTEX™ Reconstruction System (K042402)

Reference Devices

• TSRH® spinal system
• CD HORIZON® spinal system
• DYNALOK™ PLUS spinal system
• DYNALOK CLASSIC™ spinal system
• ATLAS™ cable

Submission Summary (Full Text)

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K043020

# GALAXY™ 3.2 Spinal System Summary of Safety and Effectiveness October 2004

Medtronic Sofamor Danek, Inc. USA 1. Company: 1800 Pyramid Place Memphis, TN 38132 [phone]

### Proposed Proprietary Trade Name: GALAXY(M 3.2 Spinal System II.

#### III. Spinal Interlaminal Fixation Orthosis

#### IV. Product Description

The GALAXY™ 3.2 Spinal System consists of a variety of shapes and sizes of screws, hooks, rods and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. This system is intended for posterior use only.

Titanium implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with the GALAXY™ 3.2 Spinal System. These systems include the TSRH®, CD HORIZON®, DYNALOK™ PLUS, DYNALOK CLASSIC™ spinal systems and VERTEX™ Reconstruction Systems. Additionally, titanium ATLAS cable may be used with this system at the surgeon's discretion.

The GALAXY™ 3.2 Spinal System is fabricated from medical grade titanium or titanium alloy.

The GALAXY™ 3.2 Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, cervical and/or sacral spine. The GALAXY™ 3.2 Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the GALAXY™ 3.2 Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

### V. Indications

When intended to promote fusion of the cervical spine and the thoracic spinc, (CI-T3), the GALAXYTM 3.2 Spinal System is indicated for the following:

DDD (neck pain of discogenic origin with degencration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

# Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

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# Screws/Connectors

The use of screws is limited to placement in T1-T3 only. Screws are not labeled to be placed in the posterior cervical spine.

Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.

### VI. Substantial Equivalence

VI. substantially equivalent to VERTEX™ Reconstruction System components previously cleared in K042402.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

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

Re: K043020

Trade/Device Name: Galaxy™ 3.2 Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: November 1, 2004 Received: November 3, 2004

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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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 presticated 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/dsma/dsmamain.html

Sincerely yours,

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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510(k) Number (if known): | 043020

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the GALAXY™ 3.2 Spinal System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

### Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

### Screws/Connectors

The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.

Screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.

AND/OR Over-The-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number K043020 0000003