(74 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a physical implant (facet screw) and does not mention any software, algorithms, or data processing related to AI/ML.
No
The device is a surgical implant designed to stabilize the spine and aid in fusion, which is a structural rather than a therapeutic function.
No
Explanation: The device is a facet screw indicated for stabilizing the spine as an aid to fusion. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a physical screw fabricated from stainless steel or Titanium, indicating it is a hardware device, not software.
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 and Intended Use: The 4.5mm BONE-LOK® Facet Screw is a physical implant designed to stabilize the spine. Its intended use is to aid in spinal fusion by physically immobilizing facet joints.
- No Mention of Samples or Testing: The description focuses on the physical characteristics of the screw and its surgical application. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, the device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 4.5mm BONE-LOK® Facet Screw is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.
The intended use of the 4.5mm BONE-LOK® Facet Screw is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
Product codes (comma separated list FDA assigned to the subject device)
MRW
Device Description
The 4.5mm BONE-LOK® Facet Screw is a double-helix screw with a compressionlocking collar and a self-retaining washer. It is available as a 30-40mm range device fabricated from either stainless steel, which meets the requirements of ASTM F-138, or Titanium 6Al-4V, which meets the requirements of ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facet joints, L1 to S1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Mechanical and biomechanical testing have established that the devices satisfies functional performance requirements and is safe when used as indicated.
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER INFORMATION
| A. | Company Name: | Triage Medical, Inc |
|---|---|---|
| B. | Company Address: | 13700 Alton Parkway |
| Suite 160 | ||
| Irvine, CA 92618 | ||
| C. | Company Phone: | (949) 472-0006 |
| D. | Company Facsimile: | (949) 472-0016 |
| E. | Contact Person: | Gayle Hirota |
| Manager, Quality Assurance & Regulatory Affairs |
DEVICE IDENTIFICATION
| A. Trade Name: | 4.5mm BONE-LOK® Facet Screw | |
|---|---|---|
| B. | Catalog Number: | TFCD-45-3040S / TFCD-45-3040N (Titanium alloy) |
| SFCD-45-3040S / SFCD-45-3040N (Stainless steel) | ||
| C. Common Name: | Facet screw | |
| D. Classification Name: | Unclassified | |
| E. Product Code: | MRW | |
| F. Device Class: | Class II (per 21 CFR 888.3030) |
IDENTIFICATION OF PREDICATE DEVICE
The 4.5mm BONE-LOK® Facet Screw is similar in basic design, materials and intended use to the NuVasive™ Triad™ Facet Screw System cleared under 510(k) K020411.
DEVICE DESCRIPTION
The 4.5mm BONE-LOK® Facet Screw is a double-helix screw with a compressionlocking collar and a self-retaining washer. It is available as a 30-40mm range device fabricated from either stainless steel, which meets the requirements of ASTM F-138, or Titanium 6Al-4V, which meets the requirements of ASTM F-136.
CONFIDENTIAL
1
INDICATIONS FOR USE
The 4.5mm BONE-LOK® Facet Screw is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.
INTENDED USE
The intended use of the 4.5mm BONE-LOK® Facet Screw is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 4.5mm BONE-LOK® Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
TECHNOLOGICAL CHARACTERISTICS
The 4.5mm BONE-LOK® Facet Screw is similar in materials, design, construction and mechanical performance to the predicate devices.
PERFORMANCE DATA (NON-CLINICAL)
Mechanical and biomechanical testing have established that the devices satisfies functional performance requirements and is safe when used as indicated.
BIOCOMPATIBILITY
The 4.5mm BQNE-LOK® Facet Screw is made from either surgical grade Stainless Steel, which meets the requirements of ASTM F-138, or Titanium 6Al-4V ELI, which meets the requirements of ASTM F-136. These materials are currently being utilized in a myriad of legally marketed orthopedic devices.
CONCLUSIONS DRAWN FROM STUDIES
Literature, other documentation provided, and test results demonstrate that the 4.5mm BONE-LOK® Facet Screw is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized symbol that resembles three overlapping lines or strokes, which could be interpreted as a stylized representation of a human figure or a symbol related to health and human services. The seal is black and white, and the text is arranged in a circular pattern around the central symbol.
Public Health Service
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Gayle Hirota QA/RA Manager Triage Medical, Inc. 13700 Alton Parkway, Suite 160 Irvine, California 92618
Re: K043351
Trade/Device Name: 4.5mm BONE-LOK® Facet Screw Regulation Number: Unclassified Regulation Name: None Regulatory Class: II Product Code: MRW Dated: February 1, 2005 Received: February 3, 2005
Dear Ms. Hirota:
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). and coometer fore, market the device, subject to the general controls provisions of the Act. The r ou may, morely mains 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 such 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); good manufacturing practice requirements as se 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.
3
Page 2 - Ms. Gayle Hirota
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince nounceded on a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerly, yours,
Mark Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K043351 |
|---|---|
| Device Name: | 4.5mm BONE-LOK® Facet Screw |
| Indications For Use: | The 4.5mm BONE-LOK® Facet Screw is indicated for |
| spondylolisthesis, spondylolysis, degenerative disc disease | |
| (DDD) as defined by back pain of discogenic origin as | |
| confirmed by radiographic studies, degeneration of the facets | |
| with instability and fracture, pseudoarthrosis or failed | |
| previous fusion. |
The intended use of the 4.5mm BONE-LOK® Facet Screw is
to stabilize the spine as an aid to fusion through bilateral
immobilization of the facet joints. The screws are inserted
posteriorly through the superior side of the facet, across the
facet joint and into the pedicle. The 4.5mm BONE-LOK®
Facet Screw is indicated for bilateral facet fixation, with or
without bone graft, at single or multiple levels from L1 to Sl. |
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milburn
(Division Sign-Off) (Division of General, Restorative, and Newslogical Devices
510(k) Number.
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