(181 days)
No
The device description focuses on the physical components (rods, screws, cross bars) and materials of a pedicle screw system, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as treating severe spondylolisthesis and providing stabilization for various spinal instabilities and deformities, which are conditions requiring therapeutic intervention.
No
The Fortex Pedicle Screw System is an implantable device used for immobilization and stabilization of spinal segments, not for diagnostic purposes.
No
The device description clearly outlines physical components made of titanium alloy, such as rods, pedicle screws, and cross bars, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a system of implants (screws, rods, cross bars) designed to be surgically implanted into the spine to provide stabilization and support for fusion. This is a physical implant used in vivo (within the body), not a device used to test samples in vitro (outside the body).
The Fortex Pedicle Screw System is a surgical implant device.
N/A
Intended Use / Indications for Use
The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Fortex Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Product codes
MNH, MNI
Device Description
Fortex rods are 5.5 mm diameter solid cylinders with spherically rounded ends, provided in 40 mm, 60 mm, 70 mm, 80 mm, 120 mm, 120 mm, 160 mm, 180 mm, 200 mm, and 300 mm lengths.
Each Fortex pedicle screw assembly consists of a pedicle screw, yoke, and screw cap. Self-tapping pedicle screw assemblies are provided in diameters of 4.75mm, 5.5 mm, 6.5 mm, 7.5 mm and 8.25mm. All screw assemblies are provided in lengths of 30 mm, 35 mm, 45 mm, 50 mm, and 55 mm. Screws are provided in canulated and non-canulated configurations.
The Fortex cross bar assembly is an optional component and can be used for additional stabilization. Cross bar assemblies are available in lengths from 25 mm to 81 mm.
The rods, pedicle screws and cross bars of the Fortex Pedicle Screw System are made of titanium alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 vertebra (L3 to sacrum), thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Not Found
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
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
K090224
Special 510(k): Device Modification
Fortex Pedicle Screw System
510(k) Summary
ADMINISTRATIVE INFORMATION
JUL 80 2009
X-spine Systems, Inc. Manufacturer Name: 452 Alexandersville Rd. Miamisburg, OH 45342
Telephone (937) 847-8400 FAX (937) 847-8410
Official Contact:
David Kirschman, MD Chief Medical Officer
DEVICE NAME
Classification Names: Orthosis. Spondylolisthesis Spinal Fixation Orthosis, Pedicle Spinal Fixation
Fortex Pedicle Screw System Trade/Proprietary Name:
Pedicle Screw Spinal System Common Name:
ESTABLISHMENT REGISTRATION NUMBER
X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.
DEVICE CLASSIFICATION
FDA has classified pedicle screw spinal systems as Class II devices (21 CFR 888.3070). The product code for Orthosis, Spondylolisthesis Spinal Fixation is (MNH). The product code for Orthosis, Spinal Pedicle Fixation is (MNI). These device classifications are reviewed by the Orthopedic Devices Branch.
INTENDED USE
The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Fortex Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the
Page 10 of 41
Prg 1 of 2.
1
Special 510(k): Device Modification
following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
DEVICE DESCRIPTION
Fortex Rod
Fortex rods are 5.5 mm diameter solid cylinders with spherically rounded ends, provided in 40 mm, 60 mm, 70 mm, 80 mm, 120 mm, 120 mm, 160 mm, 180 mm, 200 mm, and 300 mm lengths.
Fortex Pedicle Screw Assembly
Each Fortex pedicle screw assembly consists of a pedicle screw, yoke, and screw cap. Selftapping pedicle screw assemblies are provided in diameters of 4.75mm, 5.5 mm, 6.5 mm, 7.5 mm and 8.25mm. All screw assemblies are provided in lengths of 30 mm, 35 mm, 45 mm, 50 mm, and 55 mm. Screws are provided in canulated and non-canulated configurations.
Fortex Cross Bar Assembly
The Fortex cross bar assembly is an optional component and can be used for additional stabilization. Cross bar assemblies are available in lengths from 25 mm to 81 mm.
Material composition
The rods, pedicle screws and cross bars of the Fortex Pedicle Screw System are made of titanium alloy conforming to ASTM F136.
STATEMENT OF TECHNOLOGICAL COMPARISON
X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Fortex Pedicle Screw System is substantially equivalent in indications and design principles to the predicate Capless Pedicle Screw System (K052847) and Capless LI Pedicle Screw System (K072282).
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Page 2 of 2
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
X-Spine Systems, Inc. c/o Dr. David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Rd Miamisburg, OH 45342
JUL 3 0 2009
Re: K090224
Trade/Device Name: Fortex™ Pedicle Screw System Regulation Number: 21 CFR 888. 3070 Regulation Name: Pedicle screw spinal system . Regulatory Class: Class II Product Code: MNH, MNI Dated: June 26, 2009 Received: June 30, 2009
Dear Dr. Kirschman:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Dr. David Kirschman
forth in the quality systems (OS) 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 advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark A. Mellersen
Mark M. Melkerson Director Division of Surgical, Orthopaedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification
Fortex Pedicle Screw System
Indications for Use
510(k) Number (if known): Ki9 D224
Device Name: Fortex™ Pedicle Screw System
Indications for Use:
The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Fortex Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
ex-2 (exT for MLM)
(Division Sign-Off) Division of S. . greal, Orthopedic, and Restorative Devices
510(k) Number K090224
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