MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM

K050117 · Medtronic Sofamor Danek · KWQ · Feb 17, 2005 · Orthopedic

Device Facts

• Record ID: K050117
• Device Name: MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEDTRONIC SOFAMOR DANEK PYRAMID® ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Device Story

The PYRAMID® ANTERIOR PLATE Fixation System is a spinal orthosis consisting of titanium alloy plates and screws. It provides temporary stabilization for the lumbosacral spine to facilitate solid fusion. The system is used by surgeons in an operating room setting. Components are configured and implanted anteriorly to address various spinal pathologies, including deformities, fractures, and degenerative conditions. The device acts as a mechanical support structure; it does not involve electronic processing or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ASTM F136 or ISO 5832-3. Components: Plates and screws. Configuration: Tailor-made constructs for individual cases. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring anterior supplemental spinal fixation at the lumbosacral level below vascular bifurcation. Conditions include degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fracture, neoplasm, failed prior fusion, lordotic deformities, idiopathic scoliosis, deformities with deficient posterior elements (laminectomy, spina bifida, myelomeningocele), and neuromuscular deformity with pelvic obliquity.

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

• PYRAMID® ANTERIOR PLATE Fixation System (K013665)

Submission Summary (Full Text)

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# PYRAMID® ANTERIOR PLATE Fixation System Summary of Safety and Effectiveness January 2005

- Medtronic Sofamor Danek, Inc. USA Company: I. 1800 Pyramid Place Memphis, TN 38132 [phone]
- Richard W. Treharne, PhD Contact: Sr. Vice President, Regulatory Affairs
- Proposed Proprietary Trade Name: PYRAMID® ANTERIOR PLATE Fixation II. System
- Classification Name: Spinal Intervertebral Body Fixation Orthosis, Class II III.

Regulation Number: 21 CFR Sections 888.3050

Code: KWQ

### Product Description IV.

The PYRAMID® ANTERIOR PLATE Fixation System consists of a variety of plates and screws, as well as ancillary products and instrument sets. The PYRAMID® ANTERIOR PLATE Fixation System implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.

The Medtronic Sofamor Danek PYRAMID® ANTERIOR PLATE Fixation System is intended for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.

The purpose of this 510(k) submission is to include modified screws to the PYRAMID® ANTERIOR PLATE Fixation System.

#### V. Indications

The MEDTRONIC SOFAMOR DANEK PYRAMID® ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.

When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) anoogento engin >> Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) I bouccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida,

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or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity

## Substantial Equivalence VI.

Documentation was provided which demonstrated the PYRAMID" ANTERIOR PLATE Fixation Documentation was provided with the PYRAMID® ANTERIOR PLATE Fixation System components previously cleared in K013665.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Public Health Service

FEB 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050117

K050117
Trade Name: PYRAMID™ Anterior Plate Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: January 14, 2005 Received: January 18, 2005

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device in indicati we have reviewed your bection 9 ro(if) premium is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to tegans actment date of the Medical Device Amendments, or to commerce program to May 20, 1978, the encordance with the provisions of the Federal Food, Drug. devices that have occh recuire approval of a premarket approval application (PMA). and Cosmetic 71ct) that to neviews subject to the general controls provisions of the Act. The r ou may, merciore, market the act include requirements for annual registration, listing of general controls provisions 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 If your device to such additional controls. Existing major regulations affecting your device can thay be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may ov loand nrther announcements concerning your device in the Federal Register.

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Page 2 - Richard W. Treharne, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 ibsudited by our device complies with other requirements of the Act that I DA has made a acterimistions administered by other Federal agencies. You must of any I cut al statures and regulations and limited to: registration and listing (21 Compry with an the Hot 6 requirements) 01); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) by sound of Sections 531-542 of the Act); 21 CFR 1000-1050. product thanation control po begin marketing your device as described in your Section 510(k) I mis ictier with anow you to ogin mailing of substantial equivalence of your device to a legally premaince notineation. The 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 as not any and [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 other general informational 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,

Mark A. Mellarson

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 __ of _ January 2005

### 510(k) Number (if known): K050117

Device Name:

# PYRAMID® ANTERIOR PLATE Fixation System

# Indications for Use

The MEDTRONIC SOFAMOR DANEK PYRAMID® ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.

When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

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)

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

K050117