Release Laminoplasty Fixation System

K153735 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · NQW · Jan 21, 2016 · Orthopedic

Device Facts

• Record ID: K153735
• Device Name: Release Laminoplasty Fixation System
• Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
• Product Code: NQW · Orthopedic
• Decision Date: Jan 21, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Release® Laminoplasty Fixation System consists of implantable titanium plates and screws; used in laminoplasty or laminectomy procedures to secure graft material to the lamina. Prevents graft expulsion or spinal cord impingement. Operated by surgeons in clinical/OR settings. System includes manual surgical instruments. Device provides mechanical stabilization of the spine post-procedure.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical bench testing including ASTM F543 (screw insertion torque, torque to failure, pull-out), ASTM F2193 (cantilever bend testing), and Finite Element Analysis.

Technological Characteristics

Materials: ASTM F 136 Titanium alloy. Components: Implantable plates and screws. Manual surgical instruments (Class I exempt). Principle: Spinal interlaminal fixation orthosis. No software or electronic components.

Indications for Use

Indicated for patients undergoing laminoplasty procedures in the lower cervical and upper thoracic spine (C3 to T3) requiring graft material stabilization.

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

• Pioneer Release Laminoplasty Plating System (K113218)
• DePuy Spine, Inc. MOUNTAINEER® Laminoplasty System (K091994)

Submission Summary (Full Text)

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January 21, 2016

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

Pioneer Surgical Technology, Incorporated (DBA RTI Surgical, Incorporated) Ms. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855

Re: K153735

Trade/Device Name: Release® Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: December 22, 2015 Received: December 28, 2015

Dear Ms. Pleaugh:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

510(k) Number (if known)

## K153735

Device Name Release® Laminoplasty Fixation System

#### Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the logo for "rti surgical". The "rti" is in white text on a blue rounded square. The "i" in "rti" has a green dot above it. To the right of the blue square, the word "surgical" is written in gray.

# 510(k) Summary As required per 21 CFR Section 807 92

| Date: | December 22, 2015 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner /<br>Manufacturer: | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855 USA<br>Telephone: [phone]<br>Fax: [phone] |
| Contact Person: | Sarah Pleaugh, Regulatory Affairs Specialist |
| Device trade/<br>proprietary name: | Release® Laminoplasty Fixation System |
| Classification<br>regulation: | 21 CFR 888.3050; Spinal interlaminal fixation orthosis |
| Device class: | 2 |
| Product code: | NQW |
| Review panel: | Orthopedic |
| Predicate device | Pioneer Release Laminoplasty Plating System (K113218)<br>DePuy Spine, Inc. MOUNTAINEER® Laminoplasty System<br>(K091994) |
| Description: | The Release Laminoplasty Fixation System consists of a<br>variety of sizes of implantable plates and screws that are<br>attached to the lamina after a laminoplasty or laminectomy<br>procedure. The implantable components are manufactured<br>from medical grade ASTM F 136 Titanium alloy. The system<br>also contains Class I manual surgical instruments and<br>cases that are considered exempt from premarket<br>notification. |
| Purpose of this<br>submission: | To modify the previously cleared Pioneer Release<br>Laminoplasty Plating System (Primary Predicate - K113218). |
| Intended Use/<br>Indications for<br>Use: | The Release Laminoplasty Fixation System is intended for<br>use in the lower cervical and upper thoracic spine (C3 to<br>T3) in laminoplasty procedures. The Release Laminoplasty<br>Fixation System is used to hold the graft material in place in<br>order to prevent the graft material from expulsion, or<br>impinging the spinal cord. |
| Technological<br>characteristics: | The subject system has the same technological<br>characteristics (overall design, material, principles of<br>operation, and anatomical location of use) as the predicate.<br>The subject modifications do not impact the technological<br>characteristics as compared to K113218 |
| Substantial<br>Equivalence: | The 510(k) includes a summary of the technological<br>characteristics of the subject device as compared to the<br>predicate device. The device has the same technological<br>characteristics (i.e., design, material, principles of operation,<br>intended use) as the predicate device. The modifications to<br>the predicate K113218 system do not raise new issues of<br>safety or effectiveness. |
| Non-Clinical<br>Performance Data: | ASTM F543 (screw insertion torque, torque to failure, pull-<br>out), ASTM F2193 cantilever bend testing, and Finite<br>Element Analysis were provided to show equivalent<br>mechanical performance. The subject device, as evaluated,<br>has demonstrated substantial equivalence to the predicates. |
| Clinical<br>Performance Data: | Clinical performance data was not provided in this<br>submission for a determination of substantial equivalence. |

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