K Number
K090415
Device Name
EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
Manufacturer
Date Cleared
2009-06-01

(103 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
Device Description
The Eminent Spine Fang Plate System consists of a plate and screw. The plate, which is available in two sizes (24nm and 27mm), is designed with an 8° bend to conform to the anatomy of the anterior spine to prevent migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Additionally, the plate features two "fangs" that prevent rotation, and a screw slot for final fixation. The 5.5mm screws are available in 20mm and 25mm lengths.
More Information

No
The device description and performance studies focus on mechanical properties and structural design, with no mention of AI/ML algorithms or data processing.

No
The device is described as a plate and screw system intended for use in spinal fusion procedures to maintain the relative position of bony tissue, not to treat or cure a disease or condition.

No

This device is a surgical implant designed to maintain the position of bony tissue in spinal fusion procedures. It is a mechanical fixation device, not one that gathers or interprets data for diagnosis.

No

The device description explicitly states it consists of a "plate and screw," which are physical hardware components.

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

Here's why:

  • IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device description and intended use: The Eminent Spine Fang Plate System is a surgical implant used in spinal fusion procedures. It is a physical device intended to maintain the position of bone grafts within the body.
  • Lack of diagnostic function: The device does not perform any tests on biological samples, nor does it provide diagnostic information. Its function is purely mechanical and structural within the body.

Therefore, based on the provided information, the Eminent Spine Fang Plate System is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

Product codes

KWQ

Device Description

The Eminent Spine Fang Plate System consists of a plate and screw. The plate, which is available in two sizes (24nm and 27mm), is designed with an 8° bend to conform to the anatomy of the anterior spine to prevent migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Additionally, the plate features two "fangs" that prevent rotation, and a screw slot for final fixation. The 5.5mm screws are available in 20mm and 25mm lengths.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracolumbar to S1 spinal region

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

Mechanical test results demonstrate that the Eminent Spine Fang Plate System is substantially equivalent to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

MacroPore OS Spinal System (K010911)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.

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K090415
page 1 of 2

Eminent Spine Fang Plate System

Premarket Notification

| SUBMITTED BY | Eminent Spine
16001 Ronald Reagan Blvd
Leander, TX 78641 | |
|--------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | Pending | JUN - 1 2009 |
| OWNER/OPERATOR
NUMBER | 10028153 | |
| CONTACT PERSON | Primary
Dave Freehill
President/Co-Founder
Phone: 512-259-9002
Fax: 512-259-9515 | Alternate
Steve Courtney, M.D.
President/Co-Founder
Phone: 214-415-5243
Fax: 972-250-5651 |
| SUBMISSION PREPARED BY | Lisa Peterson
QA Consulting, Inc.
Phone: 512-507-0746 | |
| DATE PREPARED | February 13, 2009 | |
| CLASSIFICATION NAME | KWQ 888.3060- Spinal Intervertebral Body Fixation Orthosis | |
| COMMON NAME | Buttress Plate | |
| PROPRIETARY NAME | Eminent Spine Fang Plate System | |
| PREDICATE DEVICE(S) | MacroPore OS Spinal System (K010911) | |
| SUBSTANTIAL EQUIVALENCE | | |

The Eminent Spine Fang Plate System was determined to be substantially equivalent to the MacroPore OS Spinal System (K010911).

DEVICE DESCRIPTION

The Eminent Spine Fang Plate System consists of a plate and screw. The plate, which is available in two sizes (24nm and 27mm), is designed with an 8° bend to conform to the anatomy of the anterior spine to prevent migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Additionally, the plate features two "fangs" that prevent rotation, and a screw slot for final fixation. The 5.5mm screws are available in 20mm and 25mm lengths.

INDICATIONS:

The Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

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K090415
Page 2 of 2

MECHANICAL TEST DATA

Mechanical test results demonstrate that the Eminent Spine Fang Plate System is substantially equivalent to the predicate device.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eminent Spine % Mr. Dave Freehill President/Co-Founder 16001 Ronald Reagan Boulevard Leander. Texas 78641

JUN - 1 2009

Re: K090415

Trade/Device Name: Eminent Spine Fang Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: May 13, 2009 Received: May 14, 2009

Dear Mr. Freehill:

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 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 forth in the quality systems (OS) regulation (21 CFR Part 820);

3

Page 2-Mr. Freehill

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Barbara Buchner

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

Enclosure

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K090415

Page 1 of 1

INDICATIONS FOR USE

510(k) Number (if known): 12090415

Device Name:

Eminent Spine Fang Plate System

Indications for Use:

The Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

Prescription Use _ X (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)

1,096415

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hui Hui

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

510(k) Number.