(30 days)
Not Found
No
The description focuses solely on the mechanical components and materials of a spinal stabilization system, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal instabilities and deformities, which are specific medical conditions, making it a therapeutic device.
No
The REVERE™ Stabilization System is an implantable device (rods, screws, hooks, etc.) used for stabilization and immobilization of the spine as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists various hardware components such as rods, hooks, screws, caps, connectors, staples, and surgical instruments, all made of metallic materials. There is no mention of any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The REVERE™ Stabilization System is described as a system of implants (rods, screws, hooks, etc.) and surgical instruments intended for the surgical stabilization of the spine.
- Intended Use: The intended use clearly states that the system is used to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant system, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The REVERE™ Stabilization System, when used as a posterior 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the REVERE™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as a posterior non-pedicle screw fixation system, the REVERE™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/illium.
When used as an anterolateral thoracolumbar system, the REVERE™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH, KWP, KWO
Device Description
The REVERE™ Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, locking caps, t-connectors, staples, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.
The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.
The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.
Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.
T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. T-connectors from the PROTEX® system may be used with 6.5mm, 6.0mm or 5.5mm rod systems. REVERE™ Tconnectors may only be used with 5.5mm rods. Additional connectors may be used to connect two rods, and are also secured using set screws.
The REVERE™ rods are composed of titanium alloy, commercially pure titanium, or stainless steel, as specified in ASTM F136, F1295, F67, and F138. All other REVERE™ implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, and F138. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium or titanium alloy implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments in the thoracic, lumbar and sacral spine, L5-S1 vertebra, lumbosacral spine, ilium, T1-sacrum/illium, thoracolumbar spine, T8-L5.
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)
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.
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.
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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510(K) Summary: REVERE™ Additional Implants
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 415-9000 | | | MAY 28 2008 |
|---------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Contact: | Kelly J. Baker, Ph.D
Director, Clinical Affairs & Regulatory | | | |
| Device Name: | REVERE™ Uniplanar Screws | | | |
| | Classification: | Per 21 CFR as follows:
§888.3050 Spinal Interlaminal Fixation Orthosis
§888.3060 Spinal Intervertebral Body Fixation Orthosis
§888.3070 Pedicle Screw Spinal System
§888.3070 Spondylolisthesis Spinal Fixation Device System
Product Codes MNH, MNI, KWQ, KWP, NKB.
Regulatory Class II and III, Panel Code 87. | | |
| Predicate(s): | Globus Medical REVERE™ Stabilization System
K061202, SE date July 20, 2006 | | | |
Device Description:
The REVERE™ Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, locking caps, t-connectors, staples, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.
The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.
The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.
Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.
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T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. T-connectors from the PROTEX® system may be used with 6.5mm, 6.0mm or 5.5mm rod systems. REVERE™ Tconnectors may only be used with 5.5mm rods. Additional connectors may be used to connect two rods, and are also secured using set screws.
The REVERE™ rods are composed of titanium alloy, commercially pure titanium, or stainless steel, as specified in ASTM F136, F1295, F67, and F138. All other REVERE™ implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, and F138. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium or titanium alloy implants.
Intended Use:
The REVERE™ Stabilization System, when used as a posterior 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the REVERE™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as a posterior non-pedicle screw fixation system, the REVERE™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVERE™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar
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spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
Basis of Substantial Equivalence:
REVERE™ uniplanar screws are similar to the predicate REVERE™ Stabilization System implants with respect to technical characteristics, performance, and intended use. Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Globus Medical, Incorporated % Dr. Kelly Baker Director, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403
MAY 28 2008
Re: K081195
Trade/Device Name: Revere™ Uniplanar Screws Regulation Number: 21 CFR §888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWO Dated: April 25, 2008 Received: April 28, 2008
Dear Dr. Baker:
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.
4
Page 2 - Dr. Kelly Baker
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number: | K081195
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| A . Separes come and |
| ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ | ---------------------- |
|---|
REVERE™ Uniplanar Screws Device Name:
INDICATIONS:
The REVERE™ Stabilization System, when used as a posterior 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the REVERE™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bo ne graft, having implants attached to the lumbosacr al spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as a posterior non-pedicle screw fixation system, the REVERE™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc co nfirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/illium.
When used as an anterolateral thoracolumbar system, the REVERE™ Stabilization System is intended for anterol ateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
Prescription Use (Per 21 CFR §801.109) Over-The-Counter Use
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogle for axm
(Division Sign Off)
and Neurological Devices
510(k) Numbe