(89 days)
No
The document describes a mechanical implant for spinal fusion and does not mention any AI or ML components.
Yes
The device is described as an implantable system intended for the surgical treatment of various spinal conditions and provides temporary stabilization as an adjunct to spinal fusion, which constitutes a therapeutic purpose.
No
This device is described as a permanent implant designed to provide mechanical support and stability to the spine for spinal fusion, which is a treatment, not a diagnostic process.
No
The device description clearly states it is a permanent implant device made from a titanium alloy, indicating it is a physical hardware device, not software only.
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 about a person's health. This includes tests for diagnosis, monitoring, screening, and prognosis.
- Spartan S2 Facet System Description: The provided text clearly describes the Spartan S2 Facet System as a permanent implant device made from titanium alloy. It is surgically implanted into the spine to provide mechanical support and stability.
- Intended Use: The intended use is for the posterior surgical treatment of various spinal conditions, acting as an adjunct to spinal fusion. This is a surgical procedure performed directly on the patient's body, not a test performed on a specimen outside the body.
The description and intended use of the Spartan S2 Facet System align with a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spartan S2 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
- Trauma, including spinal fractures and/or dislocations;
-
- Spondylolisthesis:
-
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
-
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.
The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.
Product codes
MRW
Device Description
The Spartan S Facet System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The pre-clinical testing performed indicates that the Spartan S2 Facet System is substantially equivalent to the predicate devices and is adequate for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K020411), Oasys Bone Screw (K031657), Trans 1 Facet Screw (K073515)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
4. 510(k) Summary according to 807.92(c)
| Contact: | Tim Lusby
Amendia TM, INC
1155 Allgood Road, Suite 6
Marietta, GA 30062
770-874-0935 | |
|-----------------|--------------------------------------------------------------------------------------------------|--------------|
| Trade Name: | Spartan S3 Facet System | NOV 1 7 2009 |
| Product Class: | Unclassified | |
| Classification: | Unclassified | |
| Product Codes: | MRW | |
| Panel Code: | 87 | |
Indications for Use: The Spartan S2 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
- Trauma, including spinal fractures and/or dislocations;
-
- Spondylolisthesis:
-
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
-
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.
The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.
Device Description: The Spartan S Facet System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
Predicate Device(s): The predicate devices previously cleared by FDA are the DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K020411), Oasys Bone Screw (K031657) and the Trans 1 Facet Screw (K073515).
Performance Testing: The pre-clinical testing performed indicates that the Spartan S2 Facet System is substantially equivalent to the predicate devices and is adequate for the intended use.
Page 1 of 1.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird with stylized feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Amendia, Inc. % Silver Pine Consulting Mr. Richard Jansen President 13540 Guild Avenue Apple Valley, Minnesota 55124
NOV 17 2009
Re: K092568
Trade/Device Name: Spartan S- Facet System Regulation Number: Unclassified Regulation Name: N/A Regulatory Class: Unclassified Product Code: MRW Dated: August 19, 2009 Received: August 20, 2009
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 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
2
Page 2 - Mr. Richard Jansen
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 (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,
Jmeta J
Image /page/2/Picture/6 description: The image contains a handwritten letter 'g' in a cursive style. The letter is written in black ink and appears to be isolated on a white background. The stroke of the letter starts with a loop at the top and extends downwards with a curved tail.
Mark N. Mělkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3. Statement of Indications for Use
510(k) Number (if known): Kn92569
The Spartan S Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
-
Trauma, including spinal fractures and/or dislocations;
-
Spondylolisthesis;
-
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity:
-
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.
The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.
V Prescription Use (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)
Smita for mxu
Division Sign-Off
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_K092568 Concurrence of CDRH, Office of Device Evaluation (ODE)
8