K Number
K092464
Device Name
SPINEOLOGY FACET SCREW
Manufacturer
Date Cleared
2009-11-09

(90 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

Not Found

No
The summary describes a mechanical implant (facet screw system) for spinal stabilization and fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The device description focuses solely on the physical components and materials.

Yes.
The device is intended to stabilize the spine as an aid to fusion and is indicated for conditions such as Spondylolisthesis, Pseudoarthrosis, failed previous fusions, and Degenerative Disc Disease, all of which fall under therapeutic uses aimed at treating a disease or condition.

No
The provided text describes a medical device, the Spineology Facet Screw System, which is intended to stabilize the spine as an aid to fusion. It is a surgical implant designed for physical support and treatment, not for diagnosing conditions or generating diagnostic information.

No

The device description explicitly states the device is a "cannulated screw" made from "medical grade titanium alloy," indicating it is a physical hardware device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The provided information clearly describes a surgical implant (facet screws) intended to stabilize the spine during fusion surgery. It is a physical device used in the body, not a test performed on a sample taken from the body.

The device's purpose is mechanical stabilization, not diagnostic testing of biological samples.

N/A

Intended Use / 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.

Product codes

MRW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

L1 to S1 (inclusive) spinal levels

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

K071420, K073515

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

K092464
Page 1 of 1

Appendix CNOV - 9 2009
510(k) Summary
Applicant:Spineology Inc.
7200 Hudson Blvd North
Suite 205
St Paul, MN 55128-7055
Phone: 651-256-8500
Fax: 651-256-8505
Contact Person:Karen Roche
Date Prepared:August 3, 2009
Trade Name:Spineology Facet Screw System
Product
Classification and
Code: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 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.
Intended 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.
Summary of
Technological
Characteristics:The device is shown to be substantially equivalent to the intended
use, materials, configuration, and performance characteristics of the
predicate products.
Conclusion:The information submitted in this premarket notification supports a
determination that the Spineology Facet Screw System is
substantially equivalent in technological characteristics and
intended use to the predicate devices.

NOV - 9 2009

1

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

2

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

3

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 UseX
(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)

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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