(81 days)
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No
The summary describes a mechanical implant (plate and screws) for spinal fusion and contains no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implantable system intended to stabilize spinal grafts, promote spinal fusion, and provide temporary stabilization, all of which align with the definition of a therapeutic intervention.
No
The device description indicates it is an implant system (plates and screws) used for stabilization during spinal fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "plates and bone screws," which are physical hardware components, not software.
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: The provided description clearly states that the Spinal USA RCS Anterior Buttress Plate System is a temporary implant used to stabilize grafts and aid in spinal fusion. It is a physical device implanted into the body.
- Intended Use: The intended use is to stabilize and augment spinal fusion, which is a surgical procedure involving the musculoskeletal system, not a diagnostic test performed on a sample.
Therefore, based on the provided information, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spinal USA RCS Buttress Plate System is intended to stabilize the allograft or autograft at one level (TI-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Spinal USA RCS Anterior Buttress Plate System is a temporary implant used to prevent allograft or autograft extrusion. The Spinal USA RCS Anterior Buttress Plate System consists of plates and bone screws. The Spinal USA RCS Anterior Buttress Plate System is also intended to provide stabilization and augment development of a solid spinal fusion. The Spinal USA RCS Anterior Buttress Plate System fixates to the anterior portion of the thoracolumbar vertebral body. The construct may be employed alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. The components will be provided non-sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
TI-S1 (thoracolumbar vertebral body)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
092659
Date Summary Prepared:
August 27, 2009
Submitter Information:
Spinal USA 2050 Executive Drive Pearl, MS 39208
NOV 1 7 2009
| Contact Name:
Phone:
Fax:
E-mail: | Jeffrey Johnson
601-420-4244
601-420-5501
jeff@spinalusa.com |
|--------------------------------------------------------|--------------------------------------------------------------------------|
| Device Trade Name: | Spinal USA RCS Anterior Buttress Plate System |
| Common Name: | Anterior Buttress Plate System |
| Regulatory Number:
Classification:
Product Code: | 888.3060-Spinal Intervertebral Body Fixation Orthosis
Class II
KWQ |
INTENDED USE:
The Spinal USA RCS Buttress Plate System is intended to stabilize the allograft or autograft at one level (TI-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
DEVICE DESCRIPTION:
The Spinal USA RCS Anterior Buttress Plate System is a temporary implant used to prevent allograft or autograft extrusion. The Spinal USA RCS Anterior Buttress Plate System consists of plates and bone screws. The Spinal USA RCS Anterior Buttress Plate System is also intended to provide stabilization and augment development of a solid spinal fusion. The Spinal USA RCS Anterior Buttress Plate System fixates to the anterior portion of the thoracolumbar vertebral body. The construct may be employed alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. The components will be provided non-sterile.
EQUIVALENT DEVICE:
Documentation was provided which demonstrated the Spinal USA RCS Anterior Buttress Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of an eagle or bird in flight, composed of three curved lines. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Spinal USA % Mr. Jeffrey Johnson Manager of Regulatory Affairs 2050 Executive Drive Pearl, Mississippi 39208
NOV 17 2009
Re: K092659
Trade/Device Name: Spinal USA RCS Anterior Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 27, 2009 Received: August 28, 2009
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 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
2
Page 2 - Mr. Jeffrey Johnson
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/MedicalDevices/Safety/ReportalProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jonita 3
Mark N. Melkerson ന Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K092659
Device Name: Spinal USA RCS Anterior Buttress Plate System
Indications for Use:
The Spinal USA RCS Anterior Buttress Plate System is intended to stabilize the allograft or autograft at on level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. The 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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Souta for Mark Nekkosen
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092659