INTEGRA INTERSPINOUS PROCESS SYSTEM

K121924 · Seaspine, Inc. · PEK · Sep 4, 2013 · Orthopedic

Device Facts

• Record ID: K121924
• Device Name: INTEGRA INTERSPINOUS PROCESS SYSTEM
• Applicant: Seaspine, Inc.
• Product Code: PEK · Orthopedic
• Decision Date: Sep 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: - degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - spondylolisthesis - trauma (i.e., fracture or dislocation) - spinal tumor The device is not intended for stand-alone use.

Device Story

Integra Spinous Process System is a posterior non-pedicle supplemental fixation implant; used for single-level fusion in non-cervical spine (T1-S1). Device consists of two plates coupled by a central hub and secured with a set screw; plates feature spikes for spinous process fixation to resist rotation. Implanted by surgeons in clinical settings to provide supplemental stability; not intended for stand-alone use. Device is provided non-sterile; requires surgical implantation. Benefits include supplemental fixation to aid fusion in patients with degenerative disc disease, spondylolisthesis, trauma, or spinal tumors.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was demonstrated through mechanical testing including compression, bending, and torsion per ASTM F1717 and ASTM F1798 standards.

Technological Characteristics

Constructed from Ti-6Al-4V ELI (ASTM F136). Multicomponent system: two clamping plates, central hub, and locking set screw. Features spikes for spinous process fixation. Non-sterile, single-use. Mechanical testing performed per ASTM F1717 and ASTM F1798.

Indications for Use

Indicated for single-level, non-cervical (T1-S1) posterior supplemental fixation in patients requiring fusion due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), or spinal tumor. Not for stand-alone use.

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

• Life Spine Interspinous Fixation System (K100407)
• NuVasive® Spinous Process Plate System (K073278)

Reference Devices

• Lanx Spinous Process Fusion Plate (SPFP) (K090252, K083581, K043484)
• Medtronic CD Horizon Spinous Process Plate (K032037)

Submission Summary (Full Text)

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Integra Spinous Process System Premarket Notification

## K121924

Page 1 of 2

.

### 510(k) Summary

| Company Name: | SeaSpine, Inc.<br>An Integra Life Sciences Company<br>2302 La Mirada Drive<br>Vista, CA 92081 |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Nicholas M. Cordaro, Director of Engineering<br>E-mail: [e-mail]<br>Phone: [phone], Fax: [phone] |
| | Michelle Willis, Director of Regulatory Affairs<br>Email: [e-mail]<br>Phone: [phone], Fax: [phone] |
| Date Prepared: | August 23, 2013 |
| Trade Name:<br>Common Name:<br>Classification Name:<br>Classification:<br>Product Codes: | Integra Spinous Process System<br>Spinous Process System<br>Spinal Interlaminal Fixation Orthosis<br>21 CFR 888.3050, Class II<br>PEK |
| Device Description: | The Integra Spinous Process System consists of an implantable spacer featuring<br>plates of varying lengths with fixed hub diameters and set screws in order to<br>clamp bilaterally to the spinous processes. It is a multicomponent device<br>consisting of two plates coupled by a central hub and locked by a set screw.<br>Each plate contains spikes for fixation to the spinous process to aid in resisting<br>rotation after implantation. The device is available in a range of sizes to<br>accommodate variations in patient pathology and anatomy. It is manufactured<br>from Ti-6Al-4V ELI per ASTM F136. The device is provided non-sterile and is<br>single use only. The complete system, including insertion and accessory<br>instrumentation for implantation, is packaged in a tray for transportation,<br>cleaning and sterilization. |
| Intended Use: | Integra Spinous Process System is a posterior non-pedicle supplemental<br>fixation system intended for use at a single level in the non-cervical spine (T1-<br>S1). It is intended for plate fixation/ attachment to the spinous processes for<br>the purpose of achieving supplemental fusion in the following conditions:<br>- degenerative disc disease (defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies)<br>- spondylolisthesis<br>- trauma (i.e., fracture or dislocation)<br>- spinal tumor |
| | The device is not intended for stand-alone use. |
| • Predicate Devices: | Integra Spinous Process System is substantially equivalent, in whole or in part,<br>to the following commercially available predicate devices in design, materials,<br>indications and performance: |
| | Life Spine Interspinous Fixation System K100407<br>NuVasive® Spinous Process Plate System K073278 |

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K121924

#### 510(k) Summary

Page 2 of 2

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Lanx Spinous Process Fusion Plate (SPFP) K090252; K083581; K043484 Medtronic CD Horizon Spinous Process Plate K032037

The technological characteristics of the Integra Spinous Process device are the Technological same as the referenced devices in that it is composed of two clamping plates, a Characteristics: locking set screw, various hub diameters and Ti-6AL-4V per ASTM F136.

Performance testing and a detailed engineering analysis were provided to Testing Summary: demonstrate substantial equivalence with respect to compression bending and torsion. Test standards referenced were ASTM F1717 and ASTM F1798. Analysis and interpretation of the test results and device comparisons demonstrate that the Integra device is substantially equivalent to the predicate devices.

The information submitted in this premarket notification supports a Conclusions: determination that the Integra Spinous Process System is substantially equivalent in technological characteristics and intended use to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 04, 2013

SeaSpine, Incorporated Mr. Nicholas M. Cordaro Director of Engineering 2302 La Mirada Drive Vista, California 92081

Re: K121924

Trade/Device Name: Integra Spinous Process System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: August 27, 2013 Received: August 28, 2013

Dear Mr. Cordaro:

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

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Page 2 - Mr. Nicholas M. Cordaro

forth in the quality systems (OS) regulation (2) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH is Office of Surveillance and Biometries/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/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): K121924

Device Name: Integra Spinous Process System

Indications for Use:

Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions:

- degenerative disc disease (defined as back pain of discogenic origin with . confirmed by history and radiographic studies) degeneration of the disc
- . spondylolisthesis
- trauma (i.e., fracture or dislocation) .
- . spinal tumor

The device is not intended for stand-alone use.

Prescription Use __ ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121924.