PYRAMID ANTERIOR PLATE FIXATION SYSTEM

K013665 · Medtronic Sofamor Danek, Inc. · KWQ · Jan 29, 2002 · Orthopedic

Device Facts

• Record ID: K013665
• Device Name: PYRAMID ANTERIOR PLATE FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 29, 2002
• Decision: SESE
• Submission Type: Traditional
• 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

PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental spinal fixation construct; consists of titanium alloy plates and screws of various sizes/shapes; used to provide temporary stabilization until solid spinal fusion occurs. Implanted anteriorly at lumbosacral level by surgeons; configurations are tailor-made for individual patient cases. System provides mechanical support to the spine; benefits patient by maintaining stability during fusion process. No software or algorithmic components.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Construct consists of plates and screws made of titanium alloy (Ti-6Al-4V) per ASTM F136 or ISO 5832-3. Mechanical fixation system; modular design for patient-specific configurations. Stainless steel and titanium components are incompatible.

Indications for Use

Indicated for patients requiring anterior supplemental spinal fixation at the lumbosacral level for conditions including degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fractures, neoplastic disease, failed fusion, lordotic deformities, idiopathic scoliosis, deformities from 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

• Sofamor Danek ZPLATE-ATL™ Anterior Fixation System (K922543)
• BUTTERFLY™ PLATE Fixation System (K010632)

Reference Devices

• BONE GRAFT WASHER (K994122)

Submission Summary (Full Text)

{0}------------------------------------------------

# JAN 2 9 2002 1

KO13665 11 € 2

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

| 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 |
| | equivalent to K922543, Sofamor Danek ZPLATE-ATL™ Anterior Fixation |
| | System, which was cleared on May 19, 1993 and the BUTTERFLY™ PLATE |
| | Fixation System (K010632) which was cleared on May 31, 2001. |
| Device Description: | The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental |
| | fixation construct consisting of a variety of shapes and sizes 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-6A 1- |
| | 4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and |
| | titanium implant components must not be used together in a construct. |
| 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<br>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) |

{1}------------------------------------------------

KO13665 Of

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

## Functionality & Safety Testing: Mechanical testing was performed on the PYRAMID™ ANTERIOR PLATE Fixation System, which determined it to be substantially equivalent to the ZPLATE-ATL™ Anterior Fixation System and the BUTTERFLY™ PLATE Fixation System.

. . . . . . . . . . . . . . . . . .

The PYRAMID™ ANTERIOR PLATE Fixation System is substantially Conclusion: equivalent to K922543, Sofamor Danek ZPLATE-ATL™ Anterior Fixation System (SE 5/19/93) and to the Medtronic Sofamor Danek BONE GRAFT WASHER (K994122 SE 12/06/99).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JAN 2 9 2002

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

K013665 Re:

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: November 4, 2001 Received: November 6, 2001

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above w d we have determined the device is substantially equivalent (for the indications for use stated in and we have decemined and dered in interstate commerce prior to May 28, 1976, the enactment date aft the Medical Device Amendments, or to devices that have been reclassified in accordance with the or and the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the provisions of the Pouchal Pood, Drovisions 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 I levice 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 requlation (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 may round in the Federal Register. Please note: this response to your premarket notification your do ho me 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.

{3}------------------------------------------------

Page 2 - Dr. Richard Treharne

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, please contact the Office of Compliance 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 Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely, yours,

Mark N. Milliken

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

{4}------------------------------------------------

#### Page 1 of 1

#### 510(k) Number (if known): K013665

## 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.

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

| Prescription Use<br>per 21 CFR 801.109)<br>(Optional 1-2-96) | X | OR | Over-the-counter Use | __________ |
|--------------------------------------------------------------|---|----|----------------------|------------|
|--------------------------------------------------------------|---|----|----------------------|------------|

*for* Mark N Milkerur

| (Division Sign-Off) | |
|--------------------------------------------------------------|---------|
| Division of General, Restorative<br>and Neurological Devices | |
| 510(k) Number | K013665 |

Concurrence of CDRH, Office of Evaluation (ODE)

Pres (Per (Op