(72 days)
The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 4.5mm Standard and MA Screws.
The provided text describes a Special 510(k) Summary for a medical device called the VERTEBRON PSS™ Pedicle Screw System, specifically for the addition of 4.5mm Standard and MA Screws. The document asserts the substantial equivalence of these new components to previously cleared devices.
Based on the provided information, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Vertebron PSS™ Pedicle Screw System 4.5mm Standard and MA Screws demonstrated substantial equivalence to the Vertebron PSS™ Pedicle Screw System (K033352 & K043152) and Optima Spinal Fixation System; U&I America (K024096). |
| Mechanical Performance (ASTM F1717) | "Testing in accordance with ASTM F1717 was performed..." (Specific performance results or thresholds are NOT provided in this document) |
| Material Conformity (ASTM F136) | "The material used is medical grade titanium material that conforms to ASTM F136." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data or patient samples. The testing referred to is mechanical testing according to ASTM F1717. The sample size for this mechanical testing is not explicitly stated. The data provenance is not mentioned, as it is a laboratory-based mechanical test, not clinical data from a specific country or patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to the provided document. The "ground truth" for the device's acceptance is established through the demonstration of substantial equivalence to predicate devices, which is primarily based on mechanical testing and material conformity, not expert evaluation of a clinical "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable to the provided document for the same reasons as #3. There is no mention of a human-reviewed "test set" or adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable to the provided document. The device is a pedicle screw system, not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable to the provided document. The device is a mechanical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the acceptance of this device relies on demonstrated substantial equivalence to predicate devices. This is established through:
- Mechanical performance data (conformance to ASTM F1717).
- Material composition (conformance to ASTM F136).
- Design similarities to previously cleared devices.
- Intended use and indications being comparable to predicate devices.
8. The sample size for the training set
This section is not applicable to the provided document, as it concerns a mechanical medical device and not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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VERTEBRON PSS™ Pedicle Screw System Special 510(k) Summary June 2005
VIII. Summary of Safety and Effectiveness
- SUBMITTER: VERTEBRON Inc. 400 Long Beach Blvd. Stratford, CT 06615 (203) 380-9340
- CONTACT PERSON: Luis Nesprido Requlatory Affairs Manager
DATE PREPARED: June 2005
- CLASSIFICATION NAME: 21 CFR §888.3050 Spinal Interlaminal Fixation Orthosis 21 CFR §888.3060 Spinal Intervertebral Fixation Orthosis 21 CFR §888.3070 Pedicle Screw Spinal System
- COMMON NAME: Pedicle Screw Spinal System
PROPRIETARY NAME: VERTEBRON PSS™ Pedicle Screw System
- VERTEBRON PSS™ Pedicle Screw System K033352 & PREDICATE DEVICES: K043152
- DEVICE DESCRIPTION: The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 4.5mm Standard and MA Screws.
- The VERTEBRON PSS™ Pedicle Screw System is INTENDED USE: intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous
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K051716
Page 2 of 2
fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
MATERIALS: The material used is medical grade titanium material that conforms to ASTM F136.
SUBSTANTIAL EQUIVALENCE:
Testing in accordance with ASTM F1717 was performed and demonstrated that the VERTEBRON PSS™ Pedicle Screw System 4.5mm Standard and MA Screws are substantially equivalent to the VERTEBRON PSS™ Pedicle Screw System (K033352 & K043152), and Optima Spinal Fixation System; U&I America (K024096), which have received market clearance by the FDA.
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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2005
Mr. Luis Nesprido Manager, Regulatory Affairs VERTEBRON, Inc. 400 Long Beach Boulevard Stratford, Connecticut 06615
Re: K051716 Trade/Device Name: Vertebron PSSTM Pedicle Screw System Regulation Name: 21 CFR 888.3070(b)(1) Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis. Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MNI, MNH, KWP, KWP, KWQ Dated: July 27, 2005 Received: August 9, 2005
Dear Mr. Nesprido:
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. Luis Nesprido
This letter will allow you to begin marketing your device as described in your bection 5 0 local I ms letter will anow you to begin manketing your and equivalence of your device to a legally prematication. "The PDF maing of basification 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 at (240) 276-0120. Also, please note the regulation entitled, p Comati the Office of Compilance at (210) 216 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR Part 807.97). Missuraling by reference to premainterial in 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,
Mark A. Wilkinson
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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V. Indications for Use
510(k) Number (if known):
Device Name:
VERTEBRON PSS™ Pedicle Screw System
Indications For Use:
The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L.5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Prescription Use: × AND / OR (Per 21 CFR 801 Subpart D)
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)
Mad. A. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.