K Number
K070922
Device Name
MODIFICATION TO SPINAL USA VBR SYSTEM
Manufacturer
Date Cleared
2007-09-19

(170 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolater al surgicul approach above the bifurcation of the great vessel or via the exterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temperary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degreerative discase (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture and dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Description
The Spinal USA Anterior Lumbar Plate System consists of a range of plate and screw sizes. The plates come in sizes of: 21mm, 23mm, The screws come in 5.0mm and 5.5mm diameters and the screw lengths are 25mm, 30mm, 35mm. The plates locking mechanism is a preassembled rivet that is attached to every plate. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".
More Information

Not Found

No
The device description and intended use are for a mechanical spinal fixation system. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".

Yes
The device is described as a "supplemental fixation device" intended for "anterior lumbar (L1-S1) fixation for the following indications: degenerative discase (DDD), ... spondylolisthesis, trauma (i.e., fracture and dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion." These are all conditions that a therapeutic device would aim to treat or manage. It provides stabilization to permit spinal fusion to occur, which is a therapeutic process.

No

The device is described as a "supplemental fixation device" intended for "temporary fixation" until spinal fusion is achieved, indicating it is a treatment device, not a diagnostic one.

No

The device description explicitly states it consists of physical components (plates and screws) made from medical-grade titanium or titanium alloy.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are 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 description clearly states that the Spinal USA Anterior Lumbar Plate System is a surgical implant used for fixation and stabilization of the spine during fusion procedures. It is a physical device implanted into the body, not used to test samples outside the body.

The information provided focuses on the device's mechanical properties, surgical application, and anatomical site, all of which are characteristic of a surgical implant, not an IVD.

N/A

Intended Use / Indications for Use

The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Product codes (comma separated list FDA assigned to the subject device)

KWQ

Device Description

The Spinal USA Anterior Lumbar Plate System consists of a range of plate and screw sizes. The plates come in sizes of: 21mm, 23mm, The screws come in 5.0mm and 5.5mm diameters and the screw lengths are 25mm, 30mm, 35mm. The plates locking mechanism is a preassembled rivet that is attached to every plate. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior lumbar (L1-S1)

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)

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K022791, K052546, K013665, K061229, K061353

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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.

0

510 (k) Summary of Safety and Effectiveness

Date Summary Prepared:March 29, 2007
Submitter Information:Spinal USA
644 Lakeland East Drive Suite A
Flowood, MS 39047
Contact Name:
Phone:
Fax:
E-mail:Jeffrey Johnson
601-420-4244
601-420-5501
jeff@spinalusa.com
Device Trade Name:Spinal USA Anterior Lumbar Plate System
Common Name:Spinal Fixation System
Regulatory Number:888.3060
Classification:Class II
Product Code:KWQ
Predicate Devices:Synthes Anterior Tension Band System (K022791)
Aegis Anterior Lumbar Plate System (K052546)
Pyramid Anterior Plate Fixation System (K013665)
UnityLX Anterolateral Lumbar Plate System (K061229)
Trinica Anterior Lumbar Plate System (K061353)

INTENDED USE:

The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical apove the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion,

DEVICE DESCRIPTION:

The Spinal USA Anterior Lumbar Plate System consists of a range of plate and screw sizes. The plates come in sizes of: 21mm, 23mm, The screws come in 5.0mm and 5.5mm diameters and the screw lengths are 25mm, 30mm, 35mm. The plates locking mechanism is a preassembled rivet that is attached to every plate. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Spinal USA Anterior Lumbar Plate System to be substantially equivalent to its predicate devices with respect to performance data, intended use and indications, and basic principles of operation. As demonstrated by performance data, these technological differences do not present any new issues of safety or effectiveness.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2007

Spinal USA % Mr. Jeffery Johnson Manager, Regulatory Affairs

644 Lakeland East Drive, Suite A Flowood, Mississippi 39232

Re: K070922 Trade/Device Name: Spinal USA Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 29, 2007 Received: July 18, 2007

Dear Mr. Johnson:

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 (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.

2

Page 2 - Mr. Jeffery Johnson

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 I v(L) marketed predicate device results in a classification for your device and thus, permits your levice to proceed to the market.

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance antoll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrn

Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number : K070922

Device Name: Spinal USA Anterior Lumbar Plate System

Indications for Use:

The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolater al surgicul approach above the bifurcation of the great vessel or via the exterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temperary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degreerative discase (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture and dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara ImehdDA
Division Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) Number K070922