PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM

K071416 · Medtronic Sofamor Danek USA, Inc. · KWQ · Nov 1, 2007 · Orthopedic

Device Facts

• Record ID: K071416
• Device Name: PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation of the vascular structures or laterally above 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

Anterior lumbar plate system; supplemental fixation device for spinal fusion. Components made of titanium alloy. Provides temporary stabilization of lumbosacral spine until fusion occurs. Designed for anterior or anterolateral placement to avoid vascular interference. Used by surgeons in clinical/OR settings. Mechanical fixation device; no electronic or software components. Benefits patient by maintaining spinal alignment and stability during bone healing process.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium alloy spinal fixation plate system. Designed for anterior or anterolateral lumbosacral application. Mechanical fixation device; no energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring supplemental anterior or anterolateral spinal fixation at the lumbosacral level to achieve fusion. Conditions include degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fractures, neoplastic disease, 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)
• XANTUS® Anterior Lateral Supplemental Fixation System (K022070)

Submission Summary (Full Text)

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

K071416

NOV - 1 2007

# MEDTRONIC Sofamor Danek PYRAMID® +4 Anterior Lumbar Plate System 510(k) Summary May 2007

| I. | Company: | Medtronic Sofamor Danek, Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>[phone] |
|-----|----------------------|---------------------------------------------------------------------------------------------------|
| | Contact: | Christine Sciert, Regulatory Affairs Group Director |
| II. | Product Name: | PYRAMID® +4 Anterior Lumbar Plate System |
| | Classification Name: | Spinal Interaminal Fixation Orthosis |
| | Class II | Product Code: KWQ |
| | 21 CFR: | 888.3060 |

- III. Description: The subject device represents an expansion of the PYRAMID® ANTERIOR PLATE System. The prodicate system will be renamed the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. Like its predicate counterpart, the subject device is intended for use as an ant rior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons wit 1 options in the placement of the device to avoid interference with the vasculature, whil : still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.
- IV, Indications for Use: The Medtronic Sofamor Danek PYRAMID® +4 ANTERIOR LUMBAR PLATE System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral lev :l below the bifurcation of the vascular structures or as an or anteriorly lateral placed supplemental fixation device for the 1.1 -L5 region.

When properly used, this system will ielp 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) Neo )lastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scolio is, lordosis, and/or kyphosis) associated with deficient posterior elements such as t at resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.

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

- Substantial Equivalence: Documents tion, including mechanical test results, provided V. has demonstrated that the PYRAMID® +4 Anterior Lumbar Plate System is substantially equivalent to similar previously cleared devices such as the PYRAMID® Anterior Plate Fixation System (K01:665, 12/29/2002) and the XANTUS® Anterior Lateral Supplemental Fixation System (K022070, SE 07/22/02).

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

### PYRAMID® +4 ANTERIOR I UMBAR PLATE System 510(k) APPLICATION

#### NOTICE

The enclosed materials and descriptions contain information, which is trade secure or confidential under 21 CFR 20,61 and not disclosable to the public under the Freedom of Information Act (FOIA). If you are not able to assure us that the enclosed information will not be disclosed to the public, we request that this submission be handled by FDA in accordance with 21 CFR 20.44 relating to presubmission reviews. Consequently, until you hear otherwise from us, we ask that you keep our application for this device confidential. We consider this premarket notification confidential information. If we disclose this application to anyone except consultants or employe es, we will notify the FDA.

#### Submitter Information I .

Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: [phone] Telefax: 901-346-9738 Contact; Christine Scifert Director, Regulatory Affairs

#### Manufacturing Facilities

Warsaw Orthopedic, Inc. (also known as) Medtronic Sofamor Danek Manufacturing, Inc. 2500 Silveus Crossing Warsaw, Indiana 46582 Telephone: [phone]

Medtronic Puerto Rico Operations Co., med Rel Road 909, KM.0.4 Barrio Mariana Humacao, PR 00792

#### Device Name

Common or Usual Name: Metallic B< ne Fixation Appliance Proposed Proprietary or Trade Name: PYRAMIC™ +4 ANTERIOR LUMBAR PLATE System Classification Name: Spinal Interlaminal Fixation Orthosis

#### Establishment Registration Number

| 1030489 | Medtronic Sofamor Danek USA, Inc. |
|---------|-------------------------------------------------------------------------------------------------|
| 1824199 | Warsaw Orthopedic (also known as) Medtronic Sofamor Danek<br>Manufacturing (For reference onl/) |
| 2647346 | Medtronic Puerto Rico Operation: Co. |

#### Classification

Class II - 21 CFR 888.3060 (Orthopedic OR 87) Product Code - KWQ

#### Performance Standards (FD&C Act Section 514)

We are unaware of any performance standards for this device.

# 000008

© 2007 Medtronic Sofamor Danek USA, Inc. All rights reserved.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek, Inc. % Ms. Christine Scifert Regulatory Affairs Group Director 1800 Pyramid Place

Re: K071416

Memphis, TN 38132

Trade/Device Name: Pyramid® +4 Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 25, 2007 Received: September 26, 2007

Dear Ms. Scifert:

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.

NOV - 1 2007

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.

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

# Page 2 – Ms. Christine Scifert

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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Mark N. Millikan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 3 -

# Indications for Use

510(k) Number (if known): K071416

Device Name: Pyramid +4 Anterior Lumbar Plate System

Indications For Use:

The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation of the vascular structures or laterally above 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 myelcmenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic or liquity.

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) | |
|--------------------------------------------------------------------------------|---------|
| (Division Sign-Off) Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K071416 |