(35 days)
Not Found
No
The device description and intended use focus on a mechanical implant for spinal fixation. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device is intended to stabilize the spine as an aid to fusion and is indicated for the treatment of various medical conditions, including degenerative disc disease, trauma, and spondylolisthesis.
No
This device is a facet fixation system intended to stabilize the spine as an aid to fusion, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a partially threaded, cannulated, self-tapping screw with an articulating washer, which are physical hardware components.
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.
- PrimaLOK™FF Facet Fixation System: This device is a surgical implant (screws and washers) intended to be physically placed within the body to stabilize the spine. It does not perform any tests on bodily samples.
The provided information clearly describes a surgical implant for spinal fixation, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The PrimaLOK™FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, degenerative disease of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. 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.
Product codes (comma separated list FDA assigned to the subject device)
MRW
Device Description
The PrimaLOK™FF Facet Fixation System is a partially threaded, cannulated, self-tapping 4.5mm screw having an assembled, articulating washer. It is available in lengths from 25 to 45mm to accommodate differing anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, L1 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 (modified ASTM F2193) and axial pullout tests (ASTM F543) were used to characterize the mechanical properties of the PrimaLOK™FF Facet Fixation System. The results demonstrated that the PrimaLOK™FF Facet Fixation System is substantially equivalent to predicate device performance.
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.
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
in
| 8. 510(k) Summary | ||
|---|---|---|
| Date: | 23 August 2010 | SEP 30 2010 |
| Sponsor: | OsteoMed Spine Inc.* | |
| 3885 Arapaho Road | ||
| Addison, TX 75001 | ||
| Phone: (972) 677-4787 | ||
| Fax: (972) 677-4778 |
- wholly owned subsidiary of OsteoMed LP | |
| Contact Person: | Rebecca Ellis, Vice President, RA/QA & Organizational Excellence | |
| Proposed Trade
Name: | PrimaLOK™FF Facet Fixation System | |
| Device Classification | Unclassified, Pre-Amendment | |
| Classification Name: | Facet screw spinal device system | |
| Regulation: | - | |
| Device Product
Code: | MRW | |
| Device Description: | The PrimaLOK™FF Facet Fixation System is a partially threaded,
cannulated, self-tapping 4.5mm screw having an assembled,
articulating washer. It is available in lengths from 25 to 45mm to
accommodate differing anatomic requirements. | |
| Intended Use: | The PrimaLOK™FF Facet Fixation System is intended to stabilize the
spine as an aid to fusion through bilateral immobilization of the facet
joints. It is intended for use with or without bone graft, at a single or
multiple levels from L1 to S1 inclusive. It is indicated for the posterior
surgical treatment of any or all of the following: degenerative disc
disease (DDD) as defined by back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic
studies, degenerative disease of the facets with instability, trauma
(i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and
pseudarthrosis and failed fusions which are symptomatic or which
may cause secondary instability or deformity. 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. | |
| Materials: | The PrimaLOK™FF Facet Fixation System components are
manufactured from titanium and titanium alloy (Ti-6Al-4V) as
described by ASTM F67 and F136, respectively. | |
| Predicate Devices: | Discovery® Facet Screw (DePuy AcroMed, K012773)
Chameleon™ Fixation System (Spine Frontier, Inc. - K071420)
PERPOS™ PLS System, BONE-LOK® Implant (Interventional Spine,
Inc. - K082795) | |
1
Technological Characteristics:
The PrimaLOK™FF Facet Fixation System possesses the same technological characteristics as one or more of the predicates. These include:
- . basic design: partially threaded, cannulated screw with washer,
- material: titanium and/or titanium alloy, .
- sizing: sizes (diameter and lengths) are within the range of those . offered in the predicate systems, and
- intended use: as described above .
The PrimaLOK™ Facet Fixation System possesses a modified technological characteristic in that the assembled washer incorporates an integral feature which provides resistance to backout.
Therefore the fundamental scientific technology of the PrimaLOK™FF Facet Fixation System is the same as previously cleared devices.
Performance Data:
Static and dynamic cantilever bending (modified ASTM F2193) and axial pullout tests (ASTM F543) were used to characterize the mechanical properties of the PrimaLOK™FF Facet Fixation System. The results demonstrated that the PrimaLOK™FF Facet Fixation System is substantially equivalent to predicate device performance.
2
Image /page/2/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 representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Osteomed L.P. % BackRoads Consulting, Inc. Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, OH 44026-2141
SEP 3 0 2010
Re: K102438
Trade Name: PrimaLOK™ FF Facet Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: August 26, 2010 Received: August 27, 2010
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.
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
3
Page 2 - Karen E. Warden, Ph.D.
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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Far Dho
OEP
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
· 7. Indications for Use Statement
510(k) Number: K102438
SEP 30 2010
Device Name: PrimaLOK™FFFFFFFFFFFFFFFFFFFFFFFF
Indications for Use:
The PrimaLOK™EF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive.
It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, degenerative disease of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity.
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.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
(21 CFR 807 Subpart C)
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
$
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI02438 510(k) Number_