(35 days)
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.
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.
This 510(k) summary (K102438) describes a Class II medical device, the PrimaLOK™ FF Facet Fixation System. This system is a spinal implant intended to stabilize the spine as an aid to fusion. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data rather than clinical studies of diagnostic accuracy.
Here's an analysis of the provided information, framed by your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (PrimaLOK™FF Facet Fixation System results) |
|---|---|
| Static Cantilever Bending (modified ASTM F2193) | Demonstrated substantial equivalence to predicate device performance. |
| Dynamic Cantilever Bending (modified ASTM F2193) | Demonstrated substantial equivalence to predicate device performance. |
| Axial Pullout (ASTM F543) | Demonstrated substantial equivalence to predicate device performance. |
Note: The specific quantitative acceptance criteria (e.g., minimum load for bending, minimum pullout strength) are not detailed in this summary. The assessment is qualitative, stating "substantially equivalent." This is typical for 510(k) submissions where equivalence to existing devices is the primary goal, and detailed criteria may be internal to the sponsor and FDA.
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a physical medical device (spinal implant), not a diagnostic algorithm or AI. Therefore, the "test set" refers to the system components used for mechanical testing.
- Sample Size for Test Set: The document does not specify the exact number of PrimaLOK™FF Facet Fixation Systems or components tested for each mechanical test. This level of detail is typically found in the full test reports, which are not included in the public 510(k) summary.
- Data Provenance: The mechanical tests (static and dynamic cantilever bending, axial pullout) were conducted in a laboratory setting by OsteoMed Spine Inc. (or their contractors). This is prospective testing specifically performed to support this 510(k) submission. Country of origin for the data is implicitly the USA (where the sponsor is located and FDA operates).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. For mechanical device testing, "ground truth" is established by the standardized test methods themselves (ASTM F2193, ASTM F543) and measurements taken by qualified technicians/engineers. There are no "experts" in the sense of clinical reviewers establishing diagnostic ground truth here.
4. Adjudication Method for the Test Set
Not applicable. This is mechanical performance testing, not a clinical review process requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a spinal implant and the submission focuses on its mechanical properties and substantial equivalence to existing devices, not on the performance of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "standalone" performance here refers to the mechanical evaluation of the device itself (PrimaLOK™FF Facet Fixation System) without direct human interaction beyond the setup and execution of the tests in a laboratory environment. The tests characterize the device's inherent mechanical properties.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established by the engineering standards and methodologies used for mechanical testing. Specifically:
- Standardized Test Methods: ASTM F2193 (modified for cantilever bending) and ASTM F543 (for axial pullout). These standards define how the material properties and device performance under specific loads should be measured and interpreted.
- Predicate Device Performance: The ground truth for demonstrating substantial equivalence is the known mechanical performance of the legally marketed predicate devices. The PrimaLOK™FF system's performance is compared against these benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles and previous device designs, but not a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm in this submission.
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| 8. 510(k) Summary | ||
|---|---|---|
| Date: | 23 August 2010 | SEP 30 2010 |
| Sponsor: | OsteoMed Spine Inc.*3885 Arapaho RoadAddison, TX 75001 | |
| Phone: (972) 677-4787Fax: (972) 677-4778* wholly owned subsidiary of OsteoMed LP | ||
| Contact Person: | Rebecca Ellis, Vice President, RA/QA & Organizational Excellence | |
| Proposed TradeName: | PrimaLOK™FF Facet Fixation System | |
| Device Classification | Unclassified, Pre-Amendment | |
| Classification Name: | Facet screw spinal device system | |
| Regulation: | - | |
| Device ProductCode: | 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 toaccommodate differing anatomic requirements. | |
| Intended Use: | The PrimaLOK™FF Facet Fixation System is intended to stabilize thespine as an aid to fusion through bilateral immobilization of the facetjoints. It is intended for use with or without bone graft, at a single ormultiple levels from L1 to S1 inclusive. It is indicated for the posteriorsurgical treatment of any or all of the following: degenerative discdisease (DDD) as defined by back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies, degenerative disease of the facets with instability, trauma(i.e., fracture or dislocation), spondylolisthesis, spondylolysis, andpseudarthrosis and failed fusions which are symptomatic or whichmay cause secondary instability or deformity. For transfacet fixation,the screws are inserted through the inferior articular process acrossthe facet joint and into the pedicle. For translaminar facet fixation, thescrews are inserted through the lateral aspect of the spinousprocess, through the lamina, through the inferior articular process,across the facet joint and into the pedicle. | |
| Materials: | The PrimaLOK™FF Facet Fixation System components aremanufactured from titanium and titanium alloy (Ti-6Al-4V) asdescribed 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) |
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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.
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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
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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
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· 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_
N/A