MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM

K021226 · Medtronic Sofamor Danek · KWQ · May 13, 2002 · Orthopedic

Device Facts

• Record ID: K021226
• Device Name: MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWQ · Orthopedic
• Decision Date: May 13, 2002
• 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, and / or kyphosis) associated with pelvic obliquity.

Device Story

Supplemental anterior spinal fixation system; consists of titanium alloy plates and screws; used for temporary stabilization until solid spinal fusion occurs. Implant components configured and tailor-made for individual cases by surgeons in clinical settings. Provides mechanical support to spine; helps maintain alignment during fusion process. Benefits patient by stabilizing spinal segments affected by degenerative disease, deformity, or trauma.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ASTM F136 or ISO 5832-3. System includes plates, screws, and ancillary instruments. Non-sterile; requires sterilization. Not for use with stainless steel components.

Indications for Use

Indicated for patients requiring anterior supplemental spinal fixation at the lumbosacral level below vascular bifurcation for conditions including degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fractures, neoplastic disease, failed fusion, lordotic deformities, idiopathic scoliosis, deformities with deficient posterior elements, or 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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KO21226e p½

# MAY 1 3 2002

## Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System 510(k) Summary April 2002

| Submitter: | Medtronic Sofamor Danek USA, Inc.<br>1800 Pyramid Place<br>Memphis, TN 38132 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Richard Treharne |
| Trade Name: | PYRAMID™ ANTERIOR PLATE Fixation System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, Class II |
| Predicate Device(s): | The PYRAMID™ ANTERIOR PLATE Fixation System is substantially<br>equivalent to K013665, Medtronic Sofamor Danek PYRAMID™ ANTERIOR<br>PLATE Fixation System, which was cleared on January 29, 2002. |
| Device Description: | The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental<br>fixation construct consisting of a variety of shapes and sizes of plates, and<br>screws, as well as ancillary products and instrument sets. The PYRAMID™<br>ANTERIOR PLATE Fixation System implant components can be locked into a<br>variety of configurations, with each construct being tailor-made for the<br>individual case. The implant components are made of titanium alloy (Ti-6A1-<br>4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and<br>titanium implant components must not be used together in a construct. |
| Intended Use: | The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation<br>System is indicated for use as an anteriorly placed supplemental fixation<br>device for the lumbosacral level below the bifurcation of the vascular<br>structures.<br>When properly used, this system will help provide temporary stabilization until<br>a solid spinal fusion develops. Specific indications include: 1) Degenerative<br>disc disease (as defined by back pain of discogenic origin with degeneration of<br>the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3)<br>Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7)<br>Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9)<br>Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis,<br>lordosis, and/or kyphosis) associated with deficient posterior elements such as<br>that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) |

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|COR1226 p2/

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

Functionality & Safety Testing:

Mechanical testing was performed on the Subject PYRAMID™ ANTERIOR PLATE Fixation System, which determined it to be substantially equivalent to the Predicate PYRAMID™ ANTERIOR PLATE Fixation System

Conclusion:

The PYRAMID™ ANTERIOR PLATE Fixation System is substantially equivalent to K013665, the PYRAMID™ ANTERIOR PLATE Fixation System .

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes, possibly representing human figures or elements of health and well-being.

### MAY 1 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021226

Trade/Device Name: PYRAMID™ Anterior Plate Fixation System Regulatory Number: 21CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 17, 2002 Received: April 18, 2002

Dear Dr. Treharne:

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 - Richard W. Treharne, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 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, (2017) 594-4639 - Radikens 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 mormation on your responsible [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N. Mibena

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): CO2 & LD2 & L

### 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.

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### Concurrence of CDRH, Office of Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109) Optional 1-2-96)

Mush N. Milkersen

ision of General, Restorative and Neurological Devices

510(k) Number K021226

Over-the-counter Use