SPINEOLOGY FACET SCREW by SPINEOLOGY, INC.

The Spineology Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation.
The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Device Description

The Spineology Facet Screw System is designed to provide bilateral transfacet fixation of the lumbar facet joints. The cannulated screw is available partially or fully threaded in a range of lengths and is made from medical grade titanium alloy that complies with ASTM F-136.

AI/ML Overview

The provided document is a 510(k) summary for the Spineology Facet Screw System, a medical device. It does not describe the acceptance criteria or a study proving the device meets those criteria, as an AI/ML device would need to.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, which is a different type of approval process. The criteria typically discussed in such a summary are related to device design, materials, intended use, and performance characteristics, comparing them to already approved devices rather than establishing novel performance metrics for AI.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, AI/ML study details (test set, ground truth, experts, MRMC, standalone performance, training set) because this submission is for a physical medical device (facet screws) and does not involve AI/ML technology or associated performance studies.

Summary

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K092464
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Appendix C	NOV - 9 2009
	510(k) Summary
Applicant:	Spineology Inc.7200 Hudson Blvd NorthSuite 205St Paul, MN 55128-7055Phone: 651-256-8500Fax: 651-256-8505
Contact Person:	Karen Roche
Date Prepared:	August 3, 2009
Trade Name:	Spineology Facet Screw System
ProductClassification andCode:	Unclassified, Product Code MRW
Predicate Device(s):	K071420 ChameleonTM Fixation System (SpineFrontierTM, Inc.)K073515 TranS1 Facet Screws (TranS1, ® Inc.)
Device Description:	The Spineology Facet Screw System is designed to provide bilateraltransfacet fixation of the lumbar facet joints. The cannulated screwis available partially or fully threaded in a range of lengths and ismade from medical grade titanium alloy that complies with ASTMF-136.
Intended Use:	The Spineology Facet Screw System is intended to stabilize thespine as an aid to fusion by transfacet fixation.The device is indicated for posterior surgical treatment ofany or all of the following at the L1 to S1 (inclusive) spinallevels: Spondylolisthesis, Pseudoarthrosis or failed previousfusions which are symptomatic; Degenerative Disc Disease(DDD) as defined by back pain of discogenic origin withdegeneration of disc confirmed by history and radiographicstudies and/or degenerative disease of the facets withinstability.
Summary ofTechnologicalCharacteristics:	The device is shown to be substantially equivalent to the intendeduse, materials, configuration, and performance characteristics of thepredicate products.
Conclusion:	The information submitted in this premarket notification supports adetermination that the Spineology Facet Screw System issubstantially equivalent in technological characteristics andintended use to the predicate devices.

NOV - 9 2009

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an emblem. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The emblem is a stylized depiction of an eagle, with its wings spread and head turned to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Spineology, Inc. % Ms. Karen Roche, Vice President Operations and Technology 7200 Hudson Boulevard, N., Suite 205 Saint Paul, Minnesota 55128-7055

Re: K092464

Trade/Device Name: Spineology Facet Screw System Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: MRW Dated: August 3, 2009 Received: August 11, 2009

Dear Ms. Roche:

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.

NOV - 9 2009

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

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Page 2 - Ms. Karen Roche

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Mark H. Millbern

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix D Indications for Use Form

Device Name: Spineology Facet Screw System

Indications for Use:

The Spineology Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation.

The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milliken

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092464

Regulation Number and Section

N/A