(80 days)
Not Found
No
The summary describes a mechanical implant (facet screws) and its intended use in spinal fusion. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is used to aid in spinal fusion, treating conditions such as pseudoarthrosis, spinal stenosis, spondylolisthesis, and degenerative disc disease, which are therapeutic interventions.
No.
The TransS1® Facet Screws are an implantable device used as an aid to fusion in the lumbar spine, specifically for treatment purposes rather than diagnosis.
No
The device description explicitly states the device is made of medical grade titanium alloy, indicating it is a physical hardware device, not software.
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.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (facet screws) used for spinal fusion. It is physically implanted into the patient's body to provide structural support and aid in the fusion process.
- Lack of Testing on Samples: There is no mention of this device being used to analyze or test any biological samples. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the TranS1® Facet Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TranS1® Facet Screws are to be used in conjunction with the TranS1® AxiaLIFTM System which includes the TranS1® 3D Axial Rod™, in order to create an anterior/posterior fixation construct as an aid to fusion.
The AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIFTM System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed facet and pedicle screw systems.
The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process.
Product codes (comma separated list FDA assigned to the subject device)
MRW
Device Description
The TranS1® Facet Screws are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3 or ASTM F-138 Stainless Steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at L5-S1
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)
Not Found
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
APPENDIX II: 510(K) SUMMARY
$$\mathsf{Los_dist}$$
SEP 2 6 2005
Prepared: July 07, 2005
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular 807.92, the following summary of information is provided:
Submitter Information
| Submitter's Name and Address | Submitter's Contact Person |
|---|---|
| TranS1 Incorporated | Robert L. Sheridan |
| 1800 Sir Tyler Drive, Suite 101 | Phone: 910-509-3100 |
| Wilmington, NC 28409 | Fax: 910-509-3101 |
| Email: rsheridan@trans1inc.com |
Device Names
| Proprietary Name: | TranS1® Facet Screws |
|---|---|
| Common/Usual Name: | Posterior Facet Screw |
| Classification Name: | Unclassified Pre-Amendment Device |
| Product Code: | MRW |
| FDA Panel Code: | 87 Orthopedics |
Device Description
The TranS1® Facet Screws are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3 or ASTM F-138 Stainless Steel.
Intended Use and Indications for Use
The TranS1® Facet Screws are to be used in conjunction with the TranS1® AxiaLIFTM System which includes the TranS1® 3D Axial Rod™, in order to create an anterior/posterior fixation construct as an aid to fusion.
The AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIFTM System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed facet and pedicle screw systems.
The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process.
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Substantial Equivalence
Documentation was provided to demonstrate that the TranS1® Facet Screws are substantially equivalent to the Medtronic Sofamor Danek Townley Transfacetpedicular Screw Fixation System (K003928) and the Sofamore Danek Transfacetpedicular Screw Fixation System (K953076). The TranS1 devices are substantially equivalent to the predicate devices in intended use, level of attachment, materials, labeling, sterilization, and technological characteristics. The range of sizes of the TranS1 devices is identical to, or a subset of, the range of sizes of the predicate devices.
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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a single staff entwined by a serpent. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
SEP 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Sheridan Vice President for Regulatory and Clinical Affairs TranS1 Incorporated 1800 Sir Tyler Drive, Suite 101 Wilmington, North Carolina 28405
Re: K051856 Trade/Device Name: TranS1® Facet Screws Regulatory Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: MRW Dated: July 7, 2005 Received: July 8, 2005
Dear Mr. Sheridan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives to regists of the Medical Device Amendments, or to commerce price to May 20, 1978, in ecoordance with the provisions of the Federal Food, Drug, devices mat have been reclasined in quire approval of a premarket approval application (PMA). and Cosmetic Ac. (1107 that do not requestly subject to the general controls provisions of the Act. The I ou may, merciole, mance are as activements for annual registration, listing of general controls provisions of the rist 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 If your device is classified (500 a0070) als. Existing major regulations affecting your device can may be subject to subli duditions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dris assumes as our device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of any I catal statutes and registments, including, but not limited to: registration and listing (21 Comply with an the Not 670 cort 801); good manufacturing practice requirements as set CTN i at 607), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Mr. Robert L. Sheridan
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to ocgin marketing of substantial equivalence of your device to a legally premarket nothication. THC PDA muling of castification 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 desire specific advice for Jour as 11-07-20120. Also, please note the regulation entitled, a comact the Office of Complaned at (210) = 15 = 17 = 17 = 17 807.97). You may obtain " Misorallums by relevel to premainters within as and r the Act from the Division of Small other general information on your response in its toll-free number (800) 638-204, or Manufacturers, International and Consulting of the www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
්රිත Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX VII: INDICATIONS FOR USE FORM
Indications for use form
510(k) Number (if known):
Device Name: TranS1® Facet Screws
Indications for Use:
C10(k) Nimher
The TranS1® Facet Screws are to be used in conjunction with the TranS1® AxiaLIFTM System which includes the TranS1® 3D Axial Rod™, in order to create an anterior/posterior fixation construct as an aid to fusion.
The AxiaLIF™ System is indicated for patients requiring fusion to treat pseudoarthrosis, I ne ThiaEll - - - byothir ion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative unsuccessful provious railors, opini of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIFTM System is not intended to treat severe scollosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to Sconosis, severe spondylonomens (Simbar spine at L5-S1 in conjunction with legally marketed facet and pedicle screw systems.
The facet screws may be implanted using one of two techniques: transfacetpedicular or I he face serows may be insered bilaterally through the superior side of the facet, across the facet joint and into the pedicle. Alternatively, the facet screws may be cross inserted from the face joint and mits the peacers the opposite lamina and across the facet joint into the base of the lower vertebral transverse process.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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