(56 days)
Not Found
No
The summary does not mention any AI or ML components, image processing, or data sets for training or testing. The device description focuses on the physical implant and its mechanical properties.
Yes
Explanation: The device is indicated for the treatment of various spinal conditions and provides temporary stabilization as an adjunct to spinal fusion, making it a therapeutic device.
No
The device is described as a permanent implant designed to provide temporary stabilization as an adjunct to spinal fusion. Its intended use focuses on treatment for various spinal conditions, not on the diagnosis of these conditions.
No
The device description explicitly states it is a "permanent implant device made from a titanium alloy" and is intended to be surgically implanted. This clearly indicates it is a hardware device, not software-only.
Based on the provided information, 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 Spartan S3 Facet System is described as a "permanent implant device made from a titanium alloy" that is "to be implanted from the posterior approach."
- Intended Use: The intended use is for "posterior surgical treatment" to provide "temporary stabilization as an adjunct to spinal fusion."
This device is a surgical implant used directly within the body for structural support, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Spartan S3 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 S Facet System will provide temporary stabilization as an adjunct to spinal fusion.
Product codes (comma separated list FDA assigned to the subject device)
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. This submission ads a swivel washer and screw skirt to the 5mm diameter screw. 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 was performed following ASTM F2193-02. Testing consisted of static and dynamic cantilever bend tests with and without the swivel washer and skirt. The test results indicate that the Spartan S 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): 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.
K092568, K101364, K012773, K020411, K031657, K073515
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
N/A
0
510(k) Summary according to 807.92(c)
| Date: | November 18, 2011 |
|---|---|
| Contact: | Tim Lusby |
| Amendia™, INC | |
| 1755 W. Oak Parkway | |
| Marietta, GA 30062 | |
| 770-874-0935 | |
| Trade Name: | Spartan S³ Facet System |
| Classification: | Unclassified |
| Product Codes: | MRW |
| Panel Code: | 87 |
Indications for Use: The Spartan S3 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 S Facet System will provide temporary stabilization as an adjunct to spinal fusion.
The Spartan S Facet System is a permanent implant device made from a titanium Device Description: 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. This submission ads a swivel washer and screw skirt to the 5mm diameter screw. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
Technological Characteristics: The Spartan S Facet System has technological characteristics similar to the predicate devices. Screw sizes, materials, and use of a swivel washer and screw skirt. The swivel washer for both systems allows the screw to be directed 360° to accommodate optimal screw placement. The indications for use are the same for both systems.
The predicate devices previously cleared by FDA are the previously cleared Predicate Device(s): Spartan S2 Facet Screw System (K092568), the Lanx Concero Facet Screw System (K101364), DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K020411), Oasys Bone Screw (K031657) and the Trans1 Facet Screw (K073515).
Performance Testing: The pre-clinical testing was performed following ASTM F2193-02. Testing consisted of static and dynamic cantilever bend tests with and without the swivel washer and skirt. The test results indicate that the Spartan S Facet System is substantially equivalent to the predicate devices and is adequate for the intended use.
Conclusion: Amendia concludes that the data provided demonstrates substantial equivalence to the predicate devices.
1
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 6 2011
Amendia, Inc. % Silver Pine Consulting. LLC Rich Jansen, Pharm. D. 13540 Guild Avenue Apple Valley, Minnesota 55124
Re: K113011
Trade/Device Name: Spartan S Facet System Regulation Number: Unclassified Product Code: MR W Dated: November 18. 2011 Received: November 18, 2011
Dear Dr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 - Rich Jansen. Pharm. D.
CFR Part 807); labeling (21 CFR Part 801); medical device 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/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,
ly yours,
Fife
L. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Amendia 510(k)
Statement of Indications for Use
510(k) Number (if known): KII 301
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:
l ) 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.
Prescription Use V (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)
(Division Sign-Off) Diyslon of Surgical, Orthopedic, dic, and Restorative Devices
Pg l of
KI:3011