ESCALATE LAMINOPLASTY SYSTEM

K113802 · Stryker Spine · NQW · Apr 16, 2012 · Orthopedic

Device Facts

• Record ID: K113802
• Device Name: ESCALATE LAMINOPLASTY SYSTEM
• Applicant: Stryker Spine
• Product Code: NQW · Orthopedic
• Decision Date: Apr 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Escalate™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The system is intended to hold the lamina open following a laminoplasty procedure.

Device Story

Escalate™ Laminoplasty System is a set of spinal implants and instruments for cervical laminoplasty. Components include expandable laminoplasty plates, hinge (base) plates, and bone screws. System is used by surgeons to stabilize the lamina in an open position following decompression in the lower cervical and upper thoracic spine (C3-T3). Implants are attached to the vertebral body via screws. Device provides mechanical fixation to maintain spinal canal expansion, potentially benefiting patients by relieving pressure on the spinal cord. System is provided non-sterile and requires surgical implantation.

Clinical Evidence

Bench testing only. Performance data included static and dynamic compression loading (modified ASTM 1717-11a), screw driving insertion torque (ASTM F543-07), screw removal torque (ASTM F543), screw torque to failure (ASTM F543-07), and axial screw pull-out (ASTM F543-07).

Technological Characteristics

Titanium alloy implants. Includes expandable plates, hinge plates, and bone screws. Mechanical testing performed per ASTM F1717-11a (modified) and ASTM F543-07. Non-sterile delivery.

Indications for Use

Indicated for patients undergoing laminoplasty procedures in the lower cervical and upper thoracic spine (C3-T3) to hold the lamina open.

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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KII3802

Stryker Spine Escalate™ Laminoplasty System

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Traditional 510(k) Premarket Notification

APR 1 6 2012

| 510(k) Summary: Escalate™ Laminoplasty System | |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
| Contact Person | Ms. Simona Voic<br>Sr. Regulatory Affairs Project Manager<br>Phone: [phone]/ Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | April 13, 2012 |
| Trade Name | Escalate™ Laminoplasty System |
| Proposed Class | Class II |
| Classification Name<br>and Number | Spinal interlaminal fixation orthosis, 21 CFR §888.3050 |
| Product Code | NQW |
| Predicate Devices | The Escalate™ Laminoplasty System was shown to be substantially<br>equivalent to the devices listed below:<br>Medtronic Centerpiece™ Plate Fixation System (K050082) Synthes Arch™ Fixation System (K032534) |
| Device Description | The Escalate™ System consists of a comprehensive set of implants and instruments designed for a systematic approach to cervical laminoplasty procedures. The system features an expandable laminoplasty plate, a hinge (“Base”) plate, bone screws for fixation, and a set of instrumentation to assist in the implantation and removal of the implants. The plates have screw holes, which allow for attachment to the vertebral body. The screws to be used with the plates are available in a variety of lengths and diameters and are designed to match the anatomical requirements. The Escalate™ Laminoplasty plates and screws are manufactured from Titanium alloy and will be provided non-sterile. |
| 510(k) Summary: Escalate™ Laminoplasty System | |
| Intended Use/<br>Indications for Use | The Escalate™ Laminoplasty System is intended for use in the lower<br>cervical and upper thoracic spine (C3-T3) in laminoplasty procedures.<br>The system is intended to hold the lamina open following a<br>laminoplasty procedure. |
| Summary of the<br>Technological<br>Characteristics | The technological characteristics of the Escalate™ Laminoplasty<br>System are the same or similar to the predicate devices commercially<br>distributed. |
| Performance Data | The performance testing conducted to demonstrate substantial<br>equivalence to the predicate devices included: static and dynamic<br>compression loading (modified ASTM 1717-11a), screw driving<br>insertion torque (ASTM F543-07), screw removal torque (ASTM F543),<br>screw torque to failure (ASTM F543-07), and axial screw pull-out<br>(ASTM F543-07).<br>The performance data verifies that the subject devices are substantially<br>equivalent to the predicate devices currently on the market and have met<br>all mechanical test requirements based on the engineering rationale. |
| Substantial<br>Equivalence | The Escalate™ Laminoplasty System was determined to be<br>substantially equivalent to the above referenced predicate devices. The<br>subject system does not present any new issues of safety and<br>effectiveness. |
| Conclusion | The Escalate™ Laminoplasty System is substantially equivalent to its<br>predicate devices. Mechanical testing as well as other supporting<br>information sufficiently demonstrates the substantial equivalence of the<br>Escalate™ Laminoplasty System to the other laminoplasty fixation<br>systems. Based on this information, the subject system does not raise<br>any new issues regarding the safety or efficacy. |

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### Stryker Spine Escalate™ Laminoplasty System

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### Traditional 510(k) Premarket Notification

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Stryker Spinc % Ms. Simona Voic Senior Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

#### Re: K113802

Trade/Device Name: Escalate™ Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: March 22, 2012 Received: March 23, 2012

APR 1 6 2012

#### Dear Ms. Voic:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 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. Simona Voic

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 yours,

Mark N. Melkerson Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

OR

Enclosure

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Stryker Spine Escalate™ Laminoplasty System

Traditional 510(k) Premarket Notification

# Indications for Use

510(k) Number (if known): K | 113802

Device Name: Stryker Spine Escalate™ Laminoplasty System

Indications For Use:

The Escalate™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The system is intended to hold the lamina open following a laminoplasty procedure.

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 Surgical, Orthopedic, and Restorative Devices

510(k) Number k113802