(27 days)
No
The summary describes a mechanical pedicle screw system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as stabilizing the spinal operative site during the fusion process of a bone graft, treating conditions like degenerative disease, spondylolisthesis, and trauma, which are therapeutic interventions.
No
The device is a pedicle screw system used to stabilize the spine during fusion, not to diagnose a condition.
No
The device description explicitly states it is comprised of "non-sterile, single use, titanium alloy components" and describes physical hardware like screws, rods, hooks, and caps.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for stabilizing the spine during fusion. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a system of components (screws, rods, hooks, etc.) made of titanium alloy, designed to be surgically implanted into the vertebral body. This is consistent with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the VERTEBRON PSS Pedicle Screw System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes
NKB, KWQ, KWP, MNH, MNI
Device Description
VERTEBRON PSS Pedicle Screw System The system 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 5.5, 6.5 & 7.5mm Cannulated MA Screws & Buttress Cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal, L5-S1
Indicated Patient Age Range
skeletally mature patients
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)
Testing in accordance with ASTM F1717 was performed and demonstrated that the VERTEBRON PSS™ Pedicle Screw System Cannulated MA Screws are substantially equivalent to the VERTEBRON PSS Pedicle Screw System (K033352, K043152 & K051716), which have received market clearance by the FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
K07/376
JUN 1 3 2007
VERTEBRON™ PSS Pedicle Screw System Special 510(k) Summary Mav 2007
Summary of Safety and Effectiveness
VIII.
- SUBMITTER: VERTEBRON Inc. 400 Long Beach Blvd. Stratford. CT 06615 (203) 380-9340 CONTACT PERSON: Luis Nesprido Senior Manager Regulatory Affairs DATE PREPARED: May 16, 2007 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 PREDICATE DEVICES: VERTEBRON™ PSS Pedicle Screw System - K033352, K043152 & K051716
- DEVICE DESCRIPTION: VERTEBRON PSS Pedicle Screw System The ાંક 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 5.5, 6.5 & 7.5mm Cannulated MA Screws & Buttress Cap.
- INTENDED 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, kyphosis, and/or
1
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.
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 Cannulated MA Screws are substantially equivalent to the VERTEBRON PSS Pedicle Screw System (K033352, K043152 & K051716), which have received market clearance by the FDA.
2
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 eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VERTEBRON, Inc. % Mr. Luis Nesprido Senior Manager, Regulatory Affairs, 400 Long Beach Blvd. Stratford. Connecticut 06615
JUN 1 8 2007
Re: K071376
Trade/Device Name: VERTEBRON PSS™ Pedicle Screw System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class III Product Code: NKB, KWQ, KWP, MNH and MNI Dated: May 16, 2007. Received: May 17, 2007.
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. 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 – Mr. Luis Nesprido
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 Office of Compliance 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Harbau Bughp
Mark N.Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Mr. Luis Nesprido
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-
OC Numbers:
| Division of Enforcement A | 240-276-
0115 |
|------------------------------------------------------------------------------------|------------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-
0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-
0115 |
| General Hospital Devices Branch | 240-276-
0115 |
| General Surgery Devices Branch | 240-276-
0115 |
| Division of Enforcement B | 240-276-
0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-
0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices and
Radiological Devices | 240-276-
0120 |
5
Mr. Luis Nesprido
Indications for Use
510(k) Number (if known): K071376
Device Name: VERTEBRON PSS™ Pedicle Screw System
Indications For Use:
INDICATIONS FOR USE:
The VERTEBRON PSSIM Pedicle Screw System is intended for noncervical, nonpedicte fixation for the following indications: degenerative 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 pedicte 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.
Prescription Use x____________________________________________________________________________________________________________________________________________________ The-Counter Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-
(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)
Jubane BrienD
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Page 1 of
510(k) Number K071376