ZIP MIS INTERSPINOUS FUSION SYSTEM

K141317 · Aurora Spine, Inc. · PEK · Nov 17, 2014 · Orthopedic

Device Facts

• Record ID: K141317
• Device Name: ZIP MIS INTERSPINOUS FUSION SYSTEM
• Applicant: Aurora Spine, Inc.
• Product Code: PEK · Orthopedic
• Decision Date: Nov 17, 2014
• 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 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

The ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system designed for posterior attachment to the spinous processes of the thoracic, lumbar, and sacral spine. It features a central chamber to house bone graft material, facilitating spinal fusion. The device is used by surgeons in an operating room setting to provide immobilization and stabilization of spinal segments as an adjunct to fusion. The system includes various cylinder sizes and plate geometries to accommodate patient-specific anatomy and lordosis. By stabilizing the spinal segment, the device supports the fusion process, potentially reducing pain and improving stability in patients with degenerative disc disease, spondylolisthesis, trauma, or tumors.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, specifically Finite Element Analysis (FEA) comparing the modified components to the predicate system.

Technological Characteristics

Bilateral locking plate system for posterior spinous process fixation. Features a central chamber for bone graft. Includes flared plates with varying angles and spike orientations to accommodate lordosis. Non-cervical (T1-S1) application. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients requiring supplemental spinal fixation in the non-cervical spine (T1-S1) for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), or tumor. Not for stand-alone use; must be used with bone graft.

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

• Aurora Spine ZIP™ MIS Interspinous Fusion System (K140715)
• Aurora Spine ZIP™ MIS Interspinous Fusion System (K133091)

Submission Summary (Full Text)

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

November 17, 2014

Aurora Spine. Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K141317

Trade/Device Name: 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 17, 2014 Received: September 18, 2014

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, 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. 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 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" (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 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.

Sincerelv vours.

# 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K141317

Device Name ZIPTM MIS Interspinous Fusion System

#### Indications for Use (Describe)

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (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 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

| Contact: | Justin Eggleton<br>Director, Spine Regulatory Affairs<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800<br>[e-mail] |
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| Date Prepared: | November 17, 2014 |
| Device Trade Name: | ZIP™ MIS ULTRA Interspinous Fusion System<br>ZIP™ 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 |

# Summary of Technological Characteristics:

The purpose of this Special 510(k) is to introduce a line extension (ZIP™ Flared) to the Aurora Spine ZIP™ MIS Interspinous Fusion System that accommodates spinal level between T1 and S1 with greater lordosis. There have been no changes to the intended use of the device or its fundamental scientific technology.

# Indications For Use:

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use 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.

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### Device Description:

The Aurora Spine ZIPIM MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical 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.

# Predicate Device:

The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K140715, K133091) with respect to indications, design, function, performance and materials.

# Non-Clinical Testing:

Finite Element Analysis (FEA) testing was provided to demonstrate substantial equivalence of the modified components compared to the predicate ZIP™ MIS system. FEA testing showed the additional geometries of the subject device do not offer a worst-case scenario as compared to the predicate ZIPTM MIS Interspinous Fusion System components.

# Conclusion:

The Aurora Spine ZIP™ MIS Interspinous Fusion System has been modified to include modified spinous process fusion plates with different angles and spike orientations to accommodate varying degrees of lordosis. Substantial equivalence has been demonstrates to predicate ZIP™ MIS Interspinous Fusion System 510(k)s.