(88 days)
The TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construct as an aid to fusion.
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 (usually) at a single level 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. Bone graft must be used for both fixation methods.
For both techniques, the system is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
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.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific criteria. The document is a 510(k) Premarket Notification for TranS1® Facet Screws, which primarily focuses on establishing substantial equivalence to predicate devices and defining the device's intended use and technological characteristics.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details as this information is not present in the provided text.
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Tran]1
MAR 1 1 2008
Response for K073515
Premarket Notification [510(K)] Summary (per 21 CFR 807.92)
| Submitter: | TranS1, Inc.411 Landmark DriveWilmington, NC 28411 |
|---|---|
| Contact Person: | William Jackson910-332-1700 (phone)910-332-1701 (fax) |
| Date Prepared: | 6 March 2008 |
| Proprietary Name: | TranS1® Facet Screws |
| Common/Usual Name: | Facet Screw Spinal Device |
| Classification Name: | Unclassified |
| Product Code: | MRW |
| Predicate Devices: | TranS1® Facet Screws, K051856Medtronic Sofamor Danek Townley Transfacetpedicular ScrewFixation System, K003928 |
Sofamor Danek Transfacetpedicular Screw Fixation System, K953076
Intended use:
The TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construct as an aid to fusion.
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 (usually) at a single level 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. Bone graft must be used for both fixation methods.
For both techniques, the system is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
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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.
Technological Characteristics and Substantial Equivalence
Documentation was provided to demonstrate that the modified TranS1® Facet Screws are substantially equivalent to the original TranS1® Facet Screws (K051816) and the predicate Medtronic Sofamor Danek Townley Transfacetpedicular Screw Fixation System (K003928) and the Sofamor 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.
pay 2 of i
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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 caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a stylized wing-like element. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TranS1. Inc. % Mr. William Jackson 411 Landmark Drive Wilmington, NC 28411
MAR 1 1 2008
K073515 Re: Trade/Device Name: TranS1® Facet Screws Regulation Number: Unclassified Regulation Name: N/A Regulatory Class: Unclassified Product Code: MRW Dated: January 8, 2008 Received: January 13, 2008
Dear Mr. Jackson:
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.
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Page 2 - Mr. William Jackson
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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Tranyl
Response for K073515
Statement of Indications for Use
510(k) Number: K073515
Device Name: TranS1® Facet Screws
Indications for Use:
The TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construct as an aid to fusion.
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 (usually) at a single level 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 ioint into the base of the lower vertebral transverse process. Bone graft must be used for both fixation methods.
For both techniques, the system is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.E. Ogden Forman
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Division of General, Restorative, and Neurological Devices
510(k) Number K073515
N/A