(29 days)
Not Found
No
The 510(k) summary describes a mechanical pedicle screw system and its components. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are mechanical tests.
No
The device is intended for "immobilization of the spine" and "pedicle fixation as an adjunct to fusion," which are structural support functions, not therapeutic in nature like pain relief or direct treatment of a disease.
No
The device, GMA 2.0 Pedicle Screw System, is indicated for immobilization and fixation of the spine as an adjunct to fusion for various spinal conditions. It is an implantable system used for treatment, not for diagnosing diseases or conditions.
No
The device description explicitly states it is comprised of physical components made of Ti6A14V ELI and medical grade stainless steel, and includes instruments for implantation. This indicates a hardware-based medical device, not a software-only one.
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.
- GMA 2.0 Pedicle Screw System Function: The provided text clearly describes the GMA 2.0 Pedicle Screw System as an implantable device intended for the immobilization of the spine as an adjunct to fusion. It is a physical device used within the body to provide structural support.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition. Its purpose is therapeutic and structural.
The information provided focuses on the device's intended use for spinal fixation, its components, materials, and mechanical testing, all of which are characteristic of an implantable surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The GMA 2.0 Pedicle Screw System is intended for immobilization of the spine. The GMA 2.0 Pedicle Screw System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The GMA 2.0 Pedicle Screw System is comprised of pre-bent rods, pedicle screw assemblies with dual lead non-cannulated screws, and a set screw. Various forms and sizes of these implants are available to account for the unique anatomy of individual patients. Components are made of Ti6A14V ELI conforming to ASTM F136. The system includes a set of instruments to aid in the implantation of the device. The instruments are made of medical grade stainless steel per ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, noncervical
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)
A full suite of mechanical testing was performed as part of the original submission (K133063). The introduction of the dual lead thread for the pedicle screws required additional testing to be performed to verify strength and safety. Axial pull out per ASTM F543, static torsion per ASTM F1717, and torque to failure per ASTM F543 testing was performed on the dual lead screws.
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.
K133063 SANTIS Pedicle Screw System
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
November 13, 2019
Grafton Medical Alliance % Ms. Cassie Sopko Regulatory Engineer JALEX Medical 27865 Clemens Road, Suite 3 Westlake, Ohio 44145
Re: K192915
Trade/Device Name: GMA 2.0 Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: October 11, 2019 Received: October 15, 2019
Dear Ms. Sopko:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192915
Device Name GMA 2.0 Pedicle Screw System
Indications for Use (Describe)
The GMA 2.0 Pedicle Screw System is intended for immobilization of the spine. The GMA 2.0 Pedicle Screw System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image is a logo for GMA Surgical. The letters "GMA" are in red, with a light blue cross in the middle of the "M". Underneath the letters is a red line, and underneath the line is the word "SURGICAL" in light blue.
510(k) Summary
| Submitted By: | Grafton Medical Alliance
7416 S County Line Rd #E
Burr Ridge, IL 60527 | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Date: | 10/11/19 | | |
| Contact Person:
Contact Email:
Contact Telephone:
Contact Fax: | Cassie Sopko
csopko@jalexmedical.com
(216) 307-3918
(440) 933-7839 | | |
| Device Trade Name:
Device Classification Name:
Device Classification:
Reviewing Panel:
Product Code:
Primary Predicate Device: | GMA 2.0 Pedicle Screw System
Thoracolumbosacral Pedicle Screw System
Class II
Orthopedic
NKB
K133063 SANTISTM Pedicle Screw System
The predicate device has never been subject to a reca | | |
Device Description:
The GMA 2.0 Pedicle Screw System is comprised of pre-bent rods, pedicle screw assemblies with dual lead non-cannulated screws, and a set screw. Various forms and sizes of these implants are available to account for the unique anatomy of individual patients. Components are made of Ti6A14V ELI conforming to ASTM F136. The system includes a set of instruments to aid in the implantation of the device. The instruments are made of medical grade stainless steel per ASTM F899.
Description of Change:
GMA purchased the predicate device (K133063) from Lanterna Medical Technologies. The purpose of this submission is for GMA to obtain clearance for additional instruments and a design change from the newly acquired, legally marketed predicate device.
Compared with the predicate device, the subject device has an updated instrument set, a modified screw design, and a modified pre-bent rod design. This submission includes the introduction of dual lead screws to reduce the insertion time for each implant. The number of threads per unit length is equivalent to the predicate. With this modification, each turn of the screw will result in further distance traveled, allowing for faster insertion.
The shape of the pre-bent rods was modified from a "hook" shaped end to a round, "cone" tipped end. The hook design is specifically used for minimally invasive surgery (MIS). Since this system is not designed for MIS, the rod design was modified. Additional sizes of the pre-bent rod were also introduced. Neither the screw, nor the rod design changes affect the the intended use of the implants. There were no changes to material or sterilization parameters. These changes and relevant risks are further discussed within the submission.
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Image /page/4/Picture/1 description: The image shows the logo for GMA Surgical. The letters "GMA" are in red, with a light blue cross in the middle of the "M". A red line is underneath the letters, and the word "SURGICAL" is in light blue underneath the line. The logo is simple and professional, and the colors are eye-catching.
Intended Use:
The GMA 2.0 Pedicle Screw System is intended for immobilization of the spine. The GMA 2.0 Pedicle Screw System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (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.
Summary of Technological Characteristics:
The GMA 2.0 Pedicle Screw System and the predicates have the same intended use and fundamental scientific technology. The table below compares the predicate to the subject device:
| Information | Subject Device | Predicate | Equivalence |
|---|---|---|---|
| Common Name | Pedicle Screw System | Pedicle Screw System | Equivalent |
| Product Code | NKB | MNH, MNI, NKB | Equivalent |
| Materials | Titanium alloy | Titanium alloy | Equivalent |
| Intended Use | The GMA 2.0 Pedicle | ||
| Screw System is intended | |||
| for immobilization and | |||
| stabilization of the spine. | |||
| The GMA 2.0 Pedicle | |||
| Screw System is | |||
| indicated for posterior, | |||
| noncervical pedicle | |||
| fixation as an adjunct to | |||
| fusion in skeletally | |||
| mature patients using | |||
| autograft and/or allograft | |||
| for the following | |||
| indications: degenerative | |||
| disc disease (DDD) | |||
| (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; | The Santis Pedicle Screw | ||
| System is intended for | |||
| immobilization and | |||
| stabilization of the spine. | |||
| The Santis Pedicle Screw | |||
| System is indicated for | |||
| posterior, noncervical | |||
| pedicle fixation as an | |||
| adjunct to fusion in | |||
| skeletally mature patients | |||
| using autograft and/or | |||
| allograft for the following | |||
| indications: degenerative | |||
| disc disease (DDD) | |||
| (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 | Equivalent |
Table 1: Comparison to Predicate
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Image /page/5/Picture/1 description: The image shows the logo for GMA Surgical. The letters "GMA" are in red, with a light blue medical cross in the middle of the "M". Underneath the letters is the word "SURGICAL" in light blue. There is a red line separating the letters from the word.
| | pseudoarthrosis; and
failed previous fusion. | | |
|-------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Description | Pre-bent rods, pedicle
screw assemblies with
dual lead non-cannulated
screws, and a set screw | Straight and pre-curved
rods, pedicle screw
assemblies with both
cannulated and non-
cannulated screws,
compression retaining
assemblies, cross
connectors and a set
screw | Equivalent |
Mechanical Testing:
A full suite of mechanical testing was performed as part of the original submission (K133063). The introduction of the dual lead thread for the pedicle screws required additional testing to be performed to verify strength and safety. Axial pull out per ASTM F543, static torsion per ASTM F1717, and torque to failure per ASTM F543 testing was performed on the dual lead screws.
Conclusion:
Based on the indications for use, technological characteristics, mechanical testing, and overall comparison with the predicate device, the subject device has demonstrated substantial equivalence.