K Number
K061041
Device Name
US SPINE FACET FIXATION SYSTEM
Manufacturer
Date Cleared
2006-06-19

(66 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability. When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.
Device Description
The US Spine Facet Fixation System consists of two implantable components, the screw in various lengths and an optional washer. Both components are made from implant grade wrought Titanium 6-Aluminum 4-Vanadium (Ti6Al4V) alloy.
More Information

No
The summary describes a mechanical fixation system made of titanium and mentions biomechanical testing. There is no mention of software, algorithms, image processing, or AI/ML terms.

Yes
The device is indicated for the posterior surgical treatment of various spinal conditions, and its function to provide temporary stabilization as an adjunct to spinal bone grafting processes directly addresses health conditions.

No

The device is a Facet Fixation System intended for surgical treatment and temporary stabilization of the spine, not for diagnosing conditions.

No

The device description explicitly states it consists of "two implantable components, the screw in various lengths and an optional washer," both made from Titanium alloy. This indicates a physical, implantable hardware device, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The Facet Fixation System is described as implantable components (screws and washers) made from titanium alloy. These are physical devices intended for surgical implantation.
  • Intended Use: The intended use is for the posterior surgical treatment of various spinal conditions by providing temporary stabilization as an adjunct to spinal bone grafting. This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.

Therefore, the Facet Fixation System is a surgical implant, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2- S1 spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.

Product codes

MRW

Device Description

The US Spine Facet Fixation System consists of two implantable components, the screw in various lengths and an optional washer. Both components are made from implant grade wrought Titanium 6-Aluminum 4-Vanadium (Ti6Al4V) alloy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

C2-S1 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Biomechanical testing, including static and fatigue 3-Point Bend Testing and Cantilever Testing were performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K012773, K020411, K031657, K994308

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

JUN 19 2006

.

K061041/

510(k) Summary

| Manufacturer: | US Spine
3600 FAU Blvd., Suite 101
Boca Raton, FL 33431 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Richard Jansen, Pharm. D.
Silver Pine Consulting
13540 Guild Ave.
Apple Valley, MN 55124
Phone 952-431-5999
Fax 952-432-3245
richj@s-pineconsulting.com |
| Proprietary Name: | US Spine Facet Fixation System |
| Classification Name: | Appliance, Fixation, Spinal |
| Common/Usual Name: | Facet Screw Spinal Device System |
| Classification: | Class II |
| Predicate Devices: | DISCOVERY Facet Screw (K012773)
Triad Facet Screw System (K020411)
Oasys Bone Screw (K031657)
Townley Transfacet/Intrapedicular Screw (K994308) |
| Device Description: | The US Spine Facet Fixation System consists of two
implantable components, the screw in various lengths and
an optional washer. Both components are made from
implant grade wrought Titanium 6-Aluminum 4-Vanadium
(Ti6Al4V) alloy. |
| Indications for Use: | The Facet Fixation System is indicated for the posterior
surgical treatment of any or all of the following at the C2-
S1 spinal levels: 1) Trauma, including spinal fractures
and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis;
4) Pseudoarthrosis or failed previous fusions which are
symptomatic or which may cause secondary instability or
deformity; 5) Degenerative diseases which include: (a)
degenerative disc disease (ddd) as defined by neck and/or
back pain of discogenic origin as confirmed by patient
history with degeneration of the disc as confirmed by
radiographic studies and/or (b) degenerative disease of the
facets with instability. |

: ·

.

:

1

When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.

Performance Data:

Biomechanical testing, including static and fatigue 3-Point Bend Testing and Cantilever Testing were performed.

2

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 19 2006

US Spine % Silver Pine Consulting Rich Jansen, Pharm.D. 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K061041

Trade/Device Name: Facet Fixation System Regulation Number: N/A Regulation Name: N/A Regulatory Class: Class II Product Code: MRW Dated: May 24, 2006 Received: May 26, 2006

Dear Mr. Jansen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2 - Rich Jansen, Pharm.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Helen Lewis

or Mark N. Melkerson Director Division of General, Restoration and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Indications for Use

510(k) Number: K061041

Device Name: Facet Fixation System

Indications for Use:

The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Lewin

Division of General, Restorative, and Neurological Devices

510(k) Number K061041