SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM

K040096 · Spinal Concepts, Inc. · KWP · Jul 1, 2004 · Orthopedic

Device Facts

• Record ID: K040096
• Device Name: SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
• Applicant: Spinal Concepts, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-L5) as an adjunct to anterior interbody fusion and bone graft. The indications for the spinous process plate include spinal trauma, degenerative spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.

Device Story

Tandem Spinous Process Plate System provides posterior spinal fixation. Device consists of metal plates with rows of spikes and interconnecting male/female grommets. Plates feature slim profile and holes with spherical seats for grommet attachment. Spikes resist rotation and aid fixation to intraspinous ligament/bone graft. Used by surgeons in clinical settings as an adjunct to anterior interbody fusion and vertebral body replacement (e.g., InFix System). Provides mechanical stability to adjacent spinous processes (L1-L5) under physiologic loads, supporting fusion and treating spinal trauma, degenerative spondylolisthesis, and degenerative disc disease.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated the system exhibits functional requirements to support use under normal physiologic loads in the spine.

Technological Characteristics

System comprises spinous process plates and interconnecting male/female grommets. Plates feature slim profile, multiple rows of spikes for bone/ligament fixation, and holes with spherical seats. Mechanical fixation principle. No software or energy source.

Indications for Use

Indicated for patients requiring spinal fixation at L1-L5 levels for spinal trauma, degenerative spondylolisthesis, or degenerative disc disease. Must be used as an adjunct to anterior interbody fusion and bone graft, and only in conjunction with a vertebral body replacement device (e.g., InFix System).

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

• Meurig-Williams Plate

Reference Devices

• Spinal Concepts, Inc. InFix System

Submission Summary (Full Text)

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

### K040096 Page 1 of 1

# Spinal Concepts, Inc. Tandem Spinous Process Plate System

# 510(k) Summary of Safety and Effectiveness

JUL 0 1 2004

| SUBMITTED BY | Spinal Concepts, Inc.<br>5301 Riata Park Court, Bldg. F<br>Austin, TX 78727 |
|--------------------------------------|-----------------------------------------------------------------------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | 1649384 |
| CONTACT PERSON | Lisa Peterson<br>Regulatory Affairs Specialist |
| DATE PREPARED | January 14, 2004 |
| CLASSIFICATION NAME | Spinal interlaminal fixation orthosis, 21 CFR 888.3050. Class II. |
| COMMON NAME | Posterior Spinal Fixation System |
| PROPRIETARY NAME | Spinal Concepts, Inc. Tandem Spinous Process Plate System |
| PREDICATE DEVICES | Meurig-Williams Plate |

### DEVICE DESCRIPTION

The Tandem system consists of spinous process plates and interconnecting male and female grommets. The implants are used in combination with a vertebral body replacement device such as the Spinal Concepts, Inc. InFix System. The plates feature a slim profile, several rows of spikes, and holes on each end with a spherical seat for grommet attachment. The spikes around the plate holes resist plate rotation after implantation, while a row of spikes over the intraspinous ligament aids in fixation to any optional bone graft.

### INDICATIONS

The Tandem Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-L5) as an adjunct to anterior interbody fusion and bone graft. The indications for the spinous process plate include spinal trauma, degenerative spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.

### MECHANICAL TEST DATA

Mechanical testing demonstrated that the Tandem System exhibits the functional requirements to support its use as a spinous process plate system under normal physiologic loads in the spine.

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

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The overall design is simple and conveys a sense of authority and national identity.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 01 2004

Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727

Re: K040096

> Trade Name: Tandem Spinous Process Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: April 15, 2004 Received: April 20, 2004

Dear Ms. Peterson:

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.

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

Page 2 - Ms. Lisa Peterson

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. 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 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/cdrl/dsma/dsmamain.html.

Sincerely yours,

Miriam C. Provost.

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

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

# INDICATIONS FOR USE STATEMENT

Page 1 of 1

K040096 510(k) Number (if known):

Spinal Concepts, Inc. Tandem Spinous Process Plate System Device Name:

Indications for Use:

The Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-I no adjunct to anterior interbody fusion and bone graft. The indications for the E7 as an adjance to ancerior issinal trauma, spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: (Per 21 CFR 801.109) | X |
|----------------------------------------|--------------------------------------------|
| | OR |
| | Over-The-Counter: (Optional Format 1-2-96) |

Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K040096