MOUNTAINEER LAMINOPLASTY SYSTEM

K091994 · Depuy Spine, Inc. · NQW · Jan 7, 2010 · Orthopedic

Device Facts

• Record ID: K091994
• Device Name: MOUNTAINEER LAMINOPLASTY SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: NQW · Orthopedic
• Decision Date: Jan 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MOUNTAINEER® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord.

Device Story

MOUNTAINEER Laminoplasty System is a spinal fixation implant system consisting of titanium plates and screws. Used in lower cervical and upper thoracic spine (C3-T3) laminoplasty procedures. Plates are available in Inline, Inline Side-By-Side, and Offset Side-By-Side configurations, plus a Hinge Plate. Plates feature slots for allograft or autograft material attachment. Surgeons secure plates to lamina and lateral mass using bone screws. System includes manual surgical instruments (drivers, drill bits, plate benders, etc.). Device functions to hold or buttress bone graft material, preventing graft expulsion or spinal cord impingement. Operated by surgeons in clinical/OR settings.

Clinical Evidence

Bench testing only. Performance data was submitted to characterize the system; no clinical data was required or provided.

Technological Characteristics

Implant system composed of commercially pure titanium plates and titanium alloy screws. Plates available in Inline, Inline Side-By-Side, and Offset Side-By-Side configurations (6mm-18mm lengths) and a Hinge Plate. Screws available in 2.30mm and 2.60mm diameters (4mm-12mm lengths). Manual surgical instrumentation included. Non-active, mechanical fixation device.

Indications for Use

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

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

• Medtronic CENTERPIECE™ Plate Fixation System (K050082)
• Synthes ARCH™ Fixation System (K032534)

Submission Summary (Full Text)

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DePuy Spine MOUNTAINEER® Laminoplasty System

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### 510(k) Summary VI.

::============================================================================================================================================================================

| SUBMITTER: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 | JAN - 7 2010 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Daphney Germain | |
| DATE PREPARED: | July 1, 2009 | |
| CLASSIFICATION NAME: | Orthosis, Spine, Plate, Laminoplasty, Metal<br>§888.3050 | |
| PROPRIETARY NAME: | MOUNTAINEER® Laminoplasty System | |
| PREDICATE DEVICES: | Medtronic CENTERPIECE™ Plate Fixation System<br>(K050082)<br>Synthes ARCH™ Fixation System (K032534) | |
| DEVICE DESCRIPTION: | The proposed MOUNTAINEER Laminoplasty System<br>is an implant system that consists of various sizes of<br>plates and screws. | |
| | The proposed plates are available in various<br>configurations to address surgeon and patient needs<br>as necessary similar to the predicate devices, the<br>Medtronic CENTERPIECE Plate Fixation System<br>(K050082) and Synthes ARCH Fixation System<br>(K032534). The proposed plates are available in the<br>Inline, Inline Side-By-Side, and Offset Side-By-Side<br>configurations. The proposed plate devices come in a<br>preformed shape with holes for bone screws. The<br>plates also contain a slot in the middle portion of the<br>plate for allograft or autograft material<br>attachment. The allograft or autograft material is<br>secured to the plate using bone screws that are<br>inserted through the middle slot on the top portion of<br>the plate. The Inline, Inline Side-By-Side, and Offset<br>Side-By-Side plates are available in 6mm to 18mm<br>lengths in increments of 2mm. The three<br>configurations are manufactured from commercially<br>pure titanium as specified on the attached<br>engineering drawing. | |

displaced sectioned lamina. The proposed plate

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# DePuy Spine MOUNTAINEER® Laminoplasty System

device comes in a preformed shape with holes for bone screws. The Hinge Plate is attached to both the lamina and lateral mass using bone screws that are inserted through the holes on the top portion of the plate. The Hinge Plate is available in one length. The Hinge Plate is manufactured from commercially pure titanium as specified on the attached engineering drawing.

The screws intended for use with the plates are available in 2.30mm and 2.60mm diameters and in 4mm to 12mm lengths in increments of 2mm. The screws attach the plates to the lamina and lateral mass through the holes incorporated within the plates. The screws are manufactured from titanium alloy as specified on the attached engineering drawing.

The proposed MOUNTAINEER Laminoplasty System includes manual surgical instruments such as drivers, drill bits, graft loading block, plate holders, plate benders, rongeur, trials, and cases that are considered exempt from premarket notification.

The MOUNTAINEER® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord.

> Manufactured from Commercially Pure Titanium and Titanium Alloy.

> Performance data was submitted to characterize the MOUNTAINEER Laminoplasty System. Test data is available in Exhibit D (of the original submission).

DePuy Spine, Inc. Response to K091994

INTENDED USE:

MATERIALS:

DATA:

PERFORMANCE

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of flowing lines.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JAN - 7 2010

DePuy Spine, Inc. % Ms. Daphney Germain Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 027.67

Re: K091994

Trade/Device Name: Mountaineer Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: November 5, 2009 Received: November 6, 2009

Dear Ms. Germain:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Daphney Germain

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Obarbareluekup

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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## DePuy Spine MOUNTAINEER® Laminoplasty System

#### Indications for Use IV.

510(k) Number (if known): K091994

MOUNTAINEER® Laminoplasty System Device Name:

Indications For Use:

The MOUNTAINE:ER® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograff material from expulsion or impinging the spinal cord.

AND/OR Over-The-Counter Use __
AND/OR (21 CFR 801 Subpart C) Prescription Use (Part 21 CFR 801 Subpart D)

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

K091994 510(k) Number_

DePuy Spine, Inc. Response to Traditional 510(k) Page 1