(57 days)
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is intended to stabilize the spine as an aid to fusion and is indicated for the treatment of various degenerative diseases, trauma, and instabilities, which directly addresses a health condition.
No
The device is described as a spinal fixation system intended to stabilize the spine and aid in fusion, not to diagnose medical conditions.
No
The device description clearly states it is a "posterior facet spinal fixation system consisting of screws with and without washers," indicating it is a hardware device.
Based on the provided information, the Facet FixxTM System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is "intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints." This describes a surgical implant used directly on the patient's body to provide structural support.
- Device Description: The device is described as a "posterior facet spinal fixation system consisting of screws with and without washers." This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. The Facet FixxTM System is an implantable medical device used inside the body for structural support.
N/A
Intended Use / Indications for Use
The Facet FixxTM System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following: Degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies, Degenerative disease of the facets with instability, Trauma (i.e. fracture or dislocation), Spondylolisthesis, Spondylolysis, Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity.
Product codes
MRW
Device Description
The Facet FixxTM System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to S1 inclusive
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)
Static and dynamic cantilever bending (ASTM F2193) and axial pullout tests (ASTM F543) were used to characterize the mechanical properties of the Facet FixxTM System. The mechanical test results demonstrate the Facet FixxTM System to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Discovery® Facet Screw (K012773), CHAMELEONTM (K071420), TOWNLEY (K953076/K003928/K021705)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Section 8 - 510(k) Summary
| Date: | 14 May 2013 |
|---|---|
| Sponsor: | Nexxt Spine |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Mobile: 317-224-4223 | |
| Office: 317-436-7801 | |
| Fax: 317 245-2518 | |
| JUL 12 2013 | |
| Contact Person: | Eric Lintula, Director of Engineering |
| Trade Names: | Facet FixxTM |
| Device Classification | Unclassified |
| Common Name: | Facet screw spinal device |
| Regulation: | N/A (unclassified) |
| Device Product Code: | MRW |
| Device Description: | The Facet FixxTM System is a posterior facet spinal fixation system |
| consisting of screws with and without washers. The cannulated | |
| screw is offered partially or fully threaded in various diameter and | |
| length combinations. | |
| Intended Use: | The Facet FixxTM System is intended to stabilize the spine as an aid |
| to fusion through bilateral immobilization of the facet joints. For | |
| transfacet fixation, the screws are inserted through the inferior | |
| articular process across the facet joint and into the pedicle. For | |
| translaminar facet fixation, the screws are inserted through the lateral | |
| aspect of the spinous process, through the lamina, through the | |
| inferior articular process, across the facet joint and into the pedicle. | |
| The Facet Fixx System is intended for bilateral facet fixation, with or | |
| without bone graft, at single or multiple levels from C2 to S1 | |
| inclusive. The Facet Fixx System is indicated for treatment of any or | |
| all of the following: Degenerative disc disease (DDD) as defined by | |
| back pain of discogenic origins confirmed by history and radiographic | |
| studies, Degenerative disease of the facets with instability, Trauma | |
| (i.e. fracture or dislocation), Spondylolisthesis, Spondylolysis, | |
| Pseudoarthrosis and failed previous fusion which are symptomatic or | |
| which may cause secondary instability or deformity. | |
| Materials: | The Facet FixxTM System is manufactured from titanium alloy (Ti-6Al- |
| 4V ELI) as described by ASTM F136. | |
| Predicate Devices: | Discovery® Facet Screw (K012773), |
| CHAMELEONTM (K071420) and the | |
| TOWNLEY (K953076/K003928/K021705) | |
| Performance Data: | Static and dynamic cantilever bending (ASTM F2193) and axial |
| pullout tests (ASTM F543) were used to characterize the mechanical | |
| properties of the Facet FixxTM System. The mechanical test results | |
| demonstrate the Facet FixxTM System to be substantially equivalent | |
| to the predicate devices. | |
| Technological | |
| Characteristics: | The Facet Fixx™ System possesses the same technological |
| characteristics as the predicates. These include: | |
| basic design (full and partial threaded screw fixation system), material (titanium alloy), sizing: sizes (diameter and lengths) are within the range of those offered in the predicate systems, and anatomic location. | |
| Therefore the fundamental scientific technology of the Facet Fixx™ System is the same as previously cleared devices. | |
| Conclusion: | In comparison to the predicate devices, the Facet Fixx™ System has the same intended use (as described above), the same technological characteristics or different without raising safety and effectiveness issues (as described above) |
| Therefore the Facet Fixx™ System can be found substantially |
1
equivalent to the predicate devices.
. . . . . . . . .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES-USA
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2013
Nexxt Spine, LLC % BackRoads Consulting, Incorporated Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026-2141
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K131417
Trade/Device Name: Facet Fixx™ Spinal Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: May 14, 2013 Received: May 16, 2013
Dear Dr. Warden:
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 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Karen E. Warden, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Sincercly yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 7 - Indications for Use Statement
510(k) Number: K131417
Device Name: Facet Fixx™ Spinal Fixation System
Indications for Use:
The Facet Fixx System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origins . confirmed by history and radiographic studies
- Degenerative disease of the facets with instability ●
- Trauma (i.e. fracture or dislocation) .
- Spondylolisthesis .
- Spondylolysis .
- Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause � secondary instability or deformity
og Over-the-Counter Use Prescription Use X
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131417