(152 days)
Not Found
No
The device description and intended use clearly define a mechanical spinal screw fixation system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are biomechanical, not related to algorithmic performance.
Yes
The device is described as a "pedicle screw fixation system" that provides "immobilization and stabilization of spinal segments as an adjunct to fusion" for treating various acute and chronic instabilities of the spine. This indicates a direct therapeutic action in supporting and stabilizing the spine, which falls under the definition of a therapeutic device.
No
The device is a pedicle screw fixation system used for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like pedicle screws and connecting rods made of titanium alloy, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant used for stabilizing the spine. It is a physical device implanted into the body to provide structural support.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Modified VertiFlex® Spinal Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, NKB
Device Description
The Modified VertiFlex® Spinal Screw System is, like the predicate VertiFlex® Spinal Screw System, a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polvaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136-02, and are available in a range of diameters and lengths to accommodate anatomical requirements. Rods are available in rigid or semi-rigid forms, and are composed of titanium conforming to ASTM F67-06, or titanium alloy (Ti 6Al-4V) conforming to ASTM F136-02. Rods are available in both straight and curved styles, and in a range of lengths to accommodate both single-level and multi-level procedures. The Modified VertiFlex® Spinal Screw System may be implanted by either conventional surgical methods, or using minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the Modified VertiFlex® Spinal Screw System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile, and are intended to be sterilized by the user before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
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)
Non-clinical tests, including biomechanical studies, and those conducted in accordance with such recognized standards as ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, have demonstrated the substantial equivalence of the subject device to commerciallyavailable predicate devices in terms of performance.
No clinical testing was conducted to support this submission.
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.
VertiFlex® Spinal Screw System - (VertiFlex®, Inc.; K062670), Isobar® TTL System - (Scient'x; K991326), Dynesvs TM System - (Zimmer Spine: K031511), N Fix II (N Flex) System -- (N Spine; K061774), CD HORIZON® System - (Medtronic; K063670 & K060615), AccuFlex™ (ProtexTM) System -- (Globus Medical; K0520690 ZODIAC® DYNAMO™ System - Alphatec; K072081)
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
§ 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
Page 1 of 2
APR - 7 2008
5.0 510(k) SUMMARY
In accordance with Title 21 Code of Federal Regulations (21 CFR). Part 807, and in particular, §807.92, the following 510(k) summary is provided for the Modified VertiFlex® Spinal Screw System:
5.1 Submitted By:
VertiFlex®, Incorporated 1351 Calle Avanzado San Clemente, California 92673 Contact: Steve Reitzler, Vice President of Regulatory & Quality Assurance
Date Prepared: November 2, 2007
5.2 Device Name
Trade or Proprietary Name: Modified VertiFlex® Spinal Screw System Common or Usual Name: Pedicle Screw System Classification Name: Pedicle Screw Spinal System Classification Regulation: 21 CFR, §888.3070 Product Codes: MNH, MNI, NKB
5.3 Predicate Devices
The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate device:
VertiFlex® Spinal Screw System - (VertiFlex®, Inc.; K062670) Isobar® TTL System - (Scient'x; K991326, et seq) Dynesvs TM System - (Zimmer Spine: K031511, et seq) N Fix II (N Flex) System -- (N Spine; K061774) CD HORIZON® System - (Medtronic; K063670 & K060615) AccuFlex™ (ProtexTM) System -- (Globus Medical; K0520690 ZODIAC® DYNAMO™ System - Alphatec; K072081)
Device Description 5.4
The Modified VertiFlex® Spinal Screw System is, like the predicate VertiFlex® Spinal Screw System, a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polvaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136-02, and are available in a range of diameters and lengths to accommodate anatomical requirements. Rods are available in rigid or semi-rigid forms, and are composed of titanium conforming to ASTM F67-06, or titanium alloy (Ti 6Al-4V) conforming to ASTM F136-02. Rods are available in both straight and curved styles, and in a range of lengths to accommodate both single-level and multi-level procedures. The Modified VertiFlex® Spinal Screw System may be implanted by either conventional surgical methods, or using minimallyinvasive/percutaneous techniques. Manual instrumentation for implantation of the Modified VertiFlex® Spinal Screw System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile, and are intended to be sterilized by the user before use.
1
073143
Page 2 of 2
ર્સ્ડ Intended Use
When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.
5.6 Comparison to Predicate Devices
Testing and comparisons of design characteristics and features have established that the subject Modified VertiFlex® Spinal Screw System is substantially equivalent in design, materials of composition, indications, performance, and other features, to other commercially-available predicate pedicle screw systems having semi-rigid rods.
5.7 Summary of Non-Clinical Tests
Non-clinical tests, including biomechanical studies, and those conducted in accordance with such recognized standards as ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, have demonstrated the substantial equivalence of the subject device to commerciallyavailable predicate devices in terms of performance.
Summary of Clinical Tests 5.8
No clinical testing was conducted to support this submission.
5.9 Conclusions
The results of testing and comparisons have established the substantial equivalence of the subject device to the identified predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.
Public Health Service
APR - 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VertiFlex™, Inc. % Mr. Steve Reitzler VP. Regulatory and Quality Assurance 1351 Calle Avandazo San Clemente, California 92673
Re: K073143
Trade/Device Name: Modified VertiFlex™ Spinal Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NKB, MNI, MNH Dated: March 24, 2008 Received: March 27, 2008
Dear Mr. Reitzler:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
3
Page 2- Mr. Steve Reitzler
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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 vours.
Anuley B. Baran
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073143
Device Name: Modified VertiFlex™ Spinal Screw System
Indications for Use:
When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.
Prescription Use ﮨﮯ (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.P. Gdl forman
Division of General. Restorative. and Neurological Devices
510(k) Number Ko73143