(80 days)
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.
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.
The provided document is a 510(k) summary for the TranS1® Facet Screws, which aims to demonstrate substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing.
Instead, the submission focuses on establishing substantial equivalence based on:
- Intended Use and Indications for Use: The document clearly states the intended use of the TranS1® Facet Screws in conjunction with the TranS1® AxiaLIFTM System for spinal fusion, including specific conditions they are indicated to treat and those they are not.
- Technological Characteristics: It mentions that the screws are made of medical-grade titanium alloy or stainless steel conforming to ASTM and ISO standards.
- Comparison to Predicate Devices: The core of the submission is to demonstrate that the TranS1® Facet Screws are "substantially equivalent" to two predicate devices: the Medtronic Sofamor Danek Townley Transfacetpedicular Screw Fixation System (K003928) and the Sofamore Danek Transfacetpedicular Screw Fixation System (K953076). This equivalence is claimed for "intended use, level of attachment, materials, labeling, sterilization, and technological characteristics." The range of sizes is also stated to be identical to or a subset of the predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as such details are not present in the provided text. The 510(k) process for this device relies on demonstrating equivalence to existing legally marketed devices, rather than presenting a de novo study with specific performance acceptance criteria.
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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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Page 18
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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.
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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
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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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