ZIP MIS INTERSPINOUS FUSION SYSTEM

K133091 · Aurora Spine · PEK · Nov 27, 2013 · Orthopedic

Device Facts

• Record ID: K133091
• Device Name: ZIP MIS INTERSPINOUS FUSION SYSTEM
• Applicant: Aurora Spine
• Product Code: PEK · Orthopedic
• Decision Date: Nov 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process 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), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

Device Story

Bilateral locking plate system for posterior non-cervical spine; attaches to spinous processes to provide immobilization and stabilization as an adjunct to fusion. Implants feature superior/inferior surfaces and central chamber for bone graft. Available in various cylinder sizes to accommodate patient anatomy. Used by surgeons in clinical settings to treat degenerative disc disease, spondylolisthesis, trauma, or tumors. Provides supplemental fixation to support bone graft fusion; not intended for stand-alone use.

Clinical Evidence

Bench testing only. Performance evaluated via static compression bending, static torsion, dynamic compression bending, and disassociation testing in UHMWPE test blocks per ASTM F1717 standards.

Technological Characteristics

Bilateral locking plate system; titanium alloy (Ti-6Al-4V ELI per ASTM F136 or ISO 5832-3). Features central chamber for bone graft. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for patients requiring supplemental spinal fusion at a single level in the non-cervical spine (T1-S1) due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), or tumor. Must be used with bone graft; 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

• Lanx Spinous Process Fusion Plate (K071877)
• NuVasive Affix (K073278)

Submission Summary (Full Text)

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### 510(k) Summary

| Contact: | Justin Eggleton<br>Musculoskeletal Clinical & Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800 | NOV 27 2013 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Date Prepared: | November 26, 2013 | |
| Device Trade Name: | Aurora Spine ZIPTM MIS Interspinous Fusion System | |
| Manufacturer: | Aurora Spine, Inc.<br>1920 Palomar Point Way<br>Carlsbad, CA 92008 | |
| Common Name: | Interspinous Fusion Device | |
| Classification: | 21 CFR §888.3050; Spinal interlaminal fixation orthosis | |
| Class: | II | |
| Product Code: | PEK | |

#### Indications For Use:

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T)-SI). It is intended for plate fixation/attachment to the spinous process 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), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

#### Device Description:

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Aurora Spine ZIP™ MIS Interspinous Fusion System is manufactured from titanium alloy (Ti-6A1-4V ELI in accordance with ASTM F136 or ISO 5832-3).

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#### Predicate Device(s):

The Aurora Spine ZIP™ MIS Interspinous Fusion System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These devices include the Lanx Spinous Process Fusion Plate (K071877) and the NuVasive Affix (K073278).

#### Performance Standards:

Testing performed on this device indicates that the Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met. This testing included static compression bending, static torsion, dynamic compression bending, and disassociation testing in UHMWPE test blocks.

#### Conclusion:

The Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to predicate devices with respect to safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the top half of the circle. Inside the circle is a stylized symbol resembling three abstract human figures or forms, with flowing lines suggesting movement or connection. The symbol is black, contrasting with the white background.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 27, 2013 Aurora Spine. Incorporated % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K133091

Trade/Device Name: Aurora Spine ZIP™ MIS Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 27, 2013 Received: September 30. 2013

Dear Mr. Eggleton:

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. Iisting 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-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 – Mr. Justin Eggleton

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 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/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/ResourcesforYou/Industry/default.htm.

Sincercly 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): K133091

Device Name: Aurora Spine ZIPTM MIS Interspinous Fusion System

The Aurora Spine ZIPTM MIS Interspinous Fusion is a posterior, non-pedicie supplemental fixation device, intended for use at a single level in the non-cervical spinc (TI-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with deveneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.c., fracture or dislocation), and/or tumor. The Aurora Spine ZIPTM MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

Prescription Usc (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: K133091