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 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.

AI/ML Overview

The Aurora Spine ZIPTM MIS Interspinous Fusion System is a medical device that adds new sizes and configurations to the Aurora Spine ZIPTM MIS Interspinous Fusion System. This device is a posterior, non-pedicle supplemental fixation device. It is intended for use in the non-cervical spine (T1-S1). This device 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.

Here's an analysis of the provided information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary is for a Special 510(k) submission, which typically means adding new sizes and configurations to an already cleared device (predicate device K133091). For such submissions, the primary acceptance criteria revolve around demonstrating that the modifications do not alter the fundamental safety and effectiveness of the device compared to the predicate. This is often achieved through comparative analysis and engineering testing.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Equivalence	The modified components' materials are substantially equivalent to the predicate device's materials. This is an implicit criterion for Special 510(k)s unless stated otherwise.	The document explicitly states: "The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K133091) with respect to indications, design, function, performance and materials."
Design Equivalence	The modified components' design is substantially equivalent to the predicate device's design, ensuring no adverse impact on function or safety.	"The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K133091) with respect to indications, design, function, performance and materials."
Functional Equivalence	The modified components perform their intended function similarly to the predicate device.	"The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K133091) with respect to indications, design, function, performance and materials."
Performance Equivalence	The mechanical performance (e.g., strength, durability, stability) of the modified components meets or exceeds that of the predicate device, especially under simulated physiological loads. Specifically, in accordance with relevant ASTM standards.	"Finite element analysis (FEA) was performed, in additional to engineering rationales, on the modified components compared to the predicate ZIPTM components, and the results demonstrate that they are substantially equivalent to the predicate device. The analysis included static compression loading, static torsion, and dynamic compression per ASTM F1717-13 and axial disassociation loading." This directly addresses the performance of the new sizes/configurations matching/exceeding the predicate. Performance is deemed substantially equivalent.
Intended Use	The modifications do not change the indications for use or the fundamental scientific technology of the device.	"There have been no changes to the intended use of the device or its fundamental scientific technology." and "The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K133091) with respect to indications..."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of clinical or image-based test sets. The study involved finite element analysis (FEA) and engineering rationales of the modified components. This means computational models were used, not patient data or physical test samples in the traditional sense of a "test set" for AI/software.
Data Provenance: Not applicable. This is a mechanical/computational study, not a clinical data study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts & Qualifications: Not applicable. For FEA and engineering rationales, the "ground truth" is established by adherence to engineering principles, material science, and validated computational methods, often overseen by qualified engineers and biomechanics specialists. No human experts in the context of clinical review were used to establish ground truth for this type of study.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This was a mechanical/computational study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

MRMC Study: No. This submission describes a mechanical engineering study, not an MRMC study related to AI or human reader performance. This device is a physical implant, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Study: Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone performance does not apply.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this engineering study is based on established mechanical engineering principles, material properties, and the validated performance of the predicate device. The FEA models are built upon these principles, and their results are compared against the expected performance derived from the predicate and relevant ASTM standards (ASTM F1717-13).

8. The Sample Size for the Training Set

Sample Size: Not applicable. This is not an AI/machine learning study that would involve a "training set." The "training" in this context is the validation of the FEA models and engineering methodologies against known physical properties and standards.

9. How the Ground Truth for the Training Set was Established

How Ground Truth for Training was Established: Not applicable. There isn't a "training set" in the sense of data labeled by experts. The "ground truth" for ensuring the accuracy of the computational methods (FEA) would be established through:
- Validation of FEA models: Comparing FEA predictions to physical test results of components (either the predicate or test coupons) where experimental data is available.
- Adherence to ASTM standards: Ensuring the simulation parameters and failure criteria align with recognized industry standards for spinal implant testing (e.g., ASTM F1717-13).
- Engineering principles: The underlying equations and assumptions in finite element analysis are based on well-established principles of mechanics and material science.

Summary

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510(k) Summary

	APR 1 7 2014
Contact:	Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Date Prepared:	March 20, 2014
Device Trade Name:	ZIPTM MIS Interspinous Fusion System
Manufacturer:	Aurora Spine, Inc.1920 Palomar Point WayCarlsbad, CA 92008
Common Name:	Interspinous Fusion Device
Classification:	21 CFR 888.3050; Spinal interlaminal fixation orthosis
Class:	II
Product Code:	PEK

Reason for Special 510(k) Submission:

The purpose of this Special 510(k) is to add new sizes and configurations to the Aurora Spine ZIPM MIS Interspinous Fusion System. There have been no changes to the intended use of the device or its fundamental scientific technology.

Indications For Use:

Device Description:

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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 (K133091) with respect to indications, design, function, performance and materials.

Substantial Equivalence:

Finite element analysis (FEA) was performed, in additional to engineering rationales, on the modified components compared to the predicate ZIPTM components, and the results demonstrate that they are substantially equivalent to the predicate device. The analysis included static compression loading, static torsion, and dynamic compression per ASTM F1717-13 and axial disassociation loading.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, with three curved lines representing its wings or feathers.

Public Health Service

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

April 17, 2014

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

Re: K140715

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: March 20, 2014 Received: March 21, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 (800) 638-2041 or (301) 796-7100 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Ronald P. Jean -S for

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

K140715 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Aurora Spine ZIP™ MIS Interspinous Fusion System

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-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.

V Prescription Use (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 IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

James P. Bertram -S 2014.04.17 12:54:00 -04'00'

(Division Sign-Off) Division or Orthopedic Devices 510(k) Number: K140715

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
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.(b)
Classification. Class II.