(21 days)
Not Found
No
The summary describes a mechanical spinal implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to stabilize the spine and aid in fusion for conditions like spondylolisthesis and degenerative disc disease, which are therapeutic interventions.
No
The device is described as an implantable compression device used for spinal stabilization and fusion, not for diagnosing conditions.
No
The device description clearly indicates it is a physical screw and washer intended for surgical implantation, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The provided text describes a surgical implant (a screw with a washer) that is inserted into the body to stabilize the spine. It is a physical device used for mechanical support and fusion, not for analyzing biological samples.
The information provided clearly indicates a surgical device for internal fixation, not an IVD.
N/A
Intended Use / Indications for Use
The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or 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 LS Facet Compression Device with Polymer Washer 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 LS Facet Compression Device with Polymer Washer is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
Product codes
MRW
Device Description
The 4.5mm LS Facet Compression Device is a double-helix screw with a compressionlocking collar. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for single use only.
Devices are provided "STERILE" and are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine, facet joints, pedicle, 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
The materials the 4.5mm LS Facet Compression Device with Polymer Washer are made from meet the requirements of ASTM F-136 (titanium) or ASTM F-138 (stainless steel). The polymer washer meets the requirements of USP Class VI and ISO 10993-1. The titanium alloys, stainless steel, and polymer used are identical to a myriad of legally marketed orthopedic spinal fixation devices.
Performance test results indicate that the device is safe and satisfies functional performance requirements when used as indicated.
The test results demonstrate that the modified 4.5mm LS Facet Compression Device with Polymer Washer is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 LS Facet Compression Device with
Polymer Washer |
|----|----------------------|----------------------------------------------------------|
| B. | Catalog Number: | LSPW-45-3040 |
| C. | Common Name: | Facet Screw |
| D. | Classification Name: | Unclassified |
| E. | Product Code: | MRW |
| F. | Device Panel: | Orthopedic |
| G. | Device Class: | |
IDENTIFICATION OF MODIFIED DEVICE
The 4.5mm LS Facet Compression Device with Polymer Washer is similar in basic design and intended use to the Triage Medical BONE-LOK® 4.5mm Facet Screw, cleared under 510(k) K043351.
DEVICE DESCRIPTION
The 4.5mm LS Facet Compression Device is a double-helix screw with a compressionlocking collar. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for single use only.
Devices are provided "STERILE" and are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
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INTENDED USE
The intended use of the 4.5mm LS Facet Compression Device with Polymer Washer 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 ioint and into the pedicle. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for bilateral facet fixation, without bone graft, at single or multiple levels from L1 to Sl.
TECHNOLOGICAL CHARACTERISTICS
The 4.5mm LS Facet Compression Device with Polymer Washer is similar in basic design, construction and mechanical performance to the previously cleared BONE-LOK® 4.5mm Facet Screw. Device modifications includes washers fabricated from a polymer, as well as modifications to component shape/design and device implantation method.
BIOCOMPATIBILITY AND PERFORMANCE DATA
The materials the 4.5mm LS Facet Compression Device with Polymer Washer are made from meet the requirements of ASTM F-136 (titanium) or ASTM F-138 (stainless steel). The polymer washer meets the requirements of USP Class VI and ISO 10993-1. The titanium alloys, stainless steel, and polymer used are identical to a myriad of legally marketed orthopedic spinal fixation devices.
Performance test results indicate that the device is safe and satisfies functional performance requirements when used as indicated.
CONCLUSIONS DRAWN FROM STUDIES
The test results demonstrate that the modified 4.5mm LS Facet Compression Device with Polymer Washer is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 - 2005
Ms. Gayle Hirota QA/RA Manager Triage Medical, Inc. 13700 Alton Parkway, Suite 160 Irvine, California 92618
Re: K051949
Trade/Device Name: 4.5mm LS Facet Compression Device with Polymer Washer Regulatory Class: Unclassified Product Code: MRW Dated: July 13, 2005 Received: July 18, 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). 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 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 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. 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
3
Page 2 - Ms. Gayle Hirota
marketed predicate device results in 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 If you don't opportion as wollance 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 other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Hypt. Alvorke
A. Mark N. Malkerson, M.S.
N. Melkerson, M.S. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kos 1949 510(k) Number (if known):
Device Name:
4.5mm LS Facet Compression Device with Polymer Washer
Indications For Use:
The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or 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 LS Facet Compression Device with Polymer Washer 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 LS Facet Compression Device with Polymer Washer is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
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)
Stupt Rlurdu
Division of General, Restorative, and Neurological Devices
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510(k) Number K051949
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