LAMINOPLASTY PLATING SYSTEM

K090354 · Aesculap Implant System, Inc. · NQW · May 12, 2009 · Orthopedic

Device Facts

• Record ID: K090354
• Device Name: LAMINOPLASTY PLATING SYSTEM
• Applicant: Aesculap Implant System, Inc.
• Product Code: NQW · Orthopedic
• Decision Date: May 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap Implant Systems Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

Device Story

Implant system for spinal stabilization; consists of titanium alloy plates and screws; used in lower cervical and upper thoracic spine (C3-T3) following laminoplasty. Plates feature screw holes for attachment to vertebral body and allograft; screws available in 2mm length with various diameters. Device functions as mechanical fixation to hold or buttress allograft; prevents allograft expulsion and spinal cord impingement. Used by surgeons in clinical/OR settings. Benefits patient by maintaining structural integrity of spinal reconstruction.

Clinical Evidence

Bench testing only. Biomechanical testing performed per FDA guidance for orthopedic and spinal systems to demonstrate safety and effectiveness comparable to predicate devices.

Technological Characteristics

Materials: Titanium alloy. Components: Plates with screw holes and screws (2mm length, various diameters). Form factor: Spinal interlaminal fixation orthosis. Sterilization: Provided sterile or non-sterile.

Indications for Use

Indicated for patients undergoing laminoplasty in the lower cervical and upper thoracic spine (C3-T3) to secure allograft and prevent expulsion or spinal cord impingement.

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

• Synthes Arch Fixation System (K032534)

Submission Summary (Full Text)

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K090354

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#### 510(k) SUMMARY (as required by 21 CFR 807.92) B.

Aesculap Implant Systems Laminoplasty Plating System

January 15, 2009

| COMPANY: | Aesculap® Implant Systems (AIS), Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 6005673311 | MAY 12 2009 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT: | Lisa M. Boyle<br>800-258-1946 (phone)<br>610-791-6882 (fax) | |
| TRADE NAME: | AIS Laminoplasty Plating System | |
| COMMON NAME: | Appliance, Fixation, Interlaminal | |
| CLASSIFICATION NAME: | Orthosis, Spine, Plate, Laminoplasty, Metal | |
| REGULATION NUMBER: | 21 CFR 888.3050 | |
| PRODUCT CODE: | NQW | |

## SUBSTANTIAL EQUIVALENCE

Aesculap® Implant Systems (AIS) believes that the Laminoplasty Plating System is substantially equivalent to the Synthes Arch Fixation System (K032534).

### DEVICE DESCRIPTION

The AIS Laminoplasty Plating System is an implant system comprised of various sizes of plates that are designed to fit anatomy of the elevated lamina. The plates have screw holes, which allow for attachment to the vertebral body and the allograft. The screws to be used with the plates are available in a 2mm length with various diameters and are designed to match the anatomical requirements. The AIS Laminoplasty Plating System is manufactured from Titanium Alloy and will be provided non-sterile and or sterile.

#### INDICATIONS FOR USE

The AIS Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The AIS Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impinqement of the spinal cord.

## TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The AIS Laminoplasty Plating System is considered substantially equivalent to other leqally marketed predicate systems. Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications.

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# PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the "Spinal System 510(k)s" was completed where relevant. Testing results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems currently on the market.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

Public Health Service

Aesculap® Implant Systems (AIS), Inc. % Ms. Lisa M. Boyle 3773 Corporate Parkway Center Valley, Pennsylvania 18034

MAY 12 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K090354

Trade/Device Name: Aesculap Implant System Laminoplasty Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NOW Dated: February 9, 2009 Received: February 11, 2009

Dear Ms. Stanners:

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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requircments 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.

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Page 2- Ms. Mary Stanners

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Chateau buchnu

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

Enclosure

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#### A. INDICATIONS FOR USE STATEMENT

510(k) Number:

# Device Name: Aesculap Implant Systems Laminoplasty Plating System

#### Indications for Use:

The Aesculap Implant Systems Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

Prescription Use and/or Over-the-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

him Hici for MLM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090354