(151 days)
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Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML components.
Yes
Explanation: The device is a spinal fixation system used to treat various spinal conditions like spondylolisthesis, scoliosis, kyphosis, and fractures, aiming to correct deformity and facilitate spinal fusion. These applications directly address or alleviate a disease or condition, which aligns with the definition of a therapeutic device.
No
The device description clearly states it is a "temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion." It is a treatment device, not one used for diagnosis.
No
The device description clearly states it is a "temporary implant system" consisting of "hooks and/or screws connected to rods," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Spinal Innovations REVOLUTION ™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate spinal fusion. It is surgically implanted into the patient's spine.
- Lack of Mention of Biological Samples: There is no mention of the device being used to test biological samples or provide diagnostic information based on such testing.
The device is a surgical implant used for structural support and stabilization within the body, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Spinal Innovations REVOLUTION ™ Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a pedicle screw system 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).
When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations REVOLUTION ™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations REVOLUTION ™ Spinal Fixation System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNH, MNI
Device Description
The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes fixed and polyaxial screws of varying diameters and lengths, and hooks in varying designs and lengths, curved and straight rods and transverse connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1 joint, L3 to the sacrum segment, T1 to the sacrum segment, sacral/iliac
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biomechanical testing demonstrated that the components of the Spinal Innovations REVOLUTION TM Spinal Fixation System exhibit equivalent mechanical performance compared to predicate devices. Testing included the following:
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- Interconnection testing of individual system components per ASTM F 1798-97. The testing of these various interconnection points addresses axial, torsional, and cantilever static and fatigue testing.
Testing results of the various system components show that the data compares directly to predicate devices. Therefore, the results support that the device testing and meets or exceeds criteria and predicate devices.
- Interconnection testing of individual system components per ASTM F 1798-97. The testing of these various interconnection points addresses axial, torsional, and cantilever static and fatigue testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Silhouette™ Spinal System by Centerpulse Spine-Tech., CD Horizon Multi Axial Screw System and TSRH™ Spinal Implant System by Sofamor Danek, Inc, MOSS™ Miami System by DePuy Motech, Inc., Ascend™ Spinal System with the Shadow™ Spinal System by Spinal Innovations, Inc.
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
DEC 1 9 2003
K0 32219 p1/2
510 (K) Summary of Safety and Effectiveness
| Company Name: | Spinal Innovations, Inc. |
|---|---|
| 7850 Stage Hills Blvd. | |
| Suite 105 | |
| Bartlett, TN 38133 | |
| (901) 373-8855 | |
| (901) 373-8303 fax | |
| 510(k) Contact: | Joe Clift |
| Vive President of Regulatory | |
| Affairs | |
| (901) 373-8855 | |
| Trade Name: | Spinal Innovations REVOLUTION™ |
| Spinal Fixation System | |
| Common Name: | Hook, Rod and Screw Spinal Fixation System |
| Classification: | 888.3050 Appliance, Fixation, Spinal |
| Interlaminal - class II | |
| 888.3070 Orthosis, Spondylolisthesis Spinal | |
| Fixation - class II | |
| 888.3070 Orthosis, Spinal Pedicle Fixation - class II | |
| Device Product Code: | 87 KWP, MNH and MNI |
| Predicate Devices: | Silhouette™ Spinal System by Centerpulse |
| Spine-Tech. | |
| CD Horizon Multi Axial Screw System and | |
| TSRH™ Spinal Implant System by Sofamor | |
| Danek, Inc | |
| MOSS™ Miami System by DePuy Motech, | |
| Inc. | |
| Ascend™ Spinal System with the Shadow™ | |
| Spinal System by Spinal Innovations, Inc. |
Device Description
The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes fixed and polyaxial screws of varying diameters and lengths, and hooks in varying designs and lengths, curved and straight rods and transverse connectors.
1
K03219 p²/₂
Intended Use
The Spinal Innovations REVOLUTION ™ Spinal Fixation System, when used as a pedicle screw The Spinal Innovations ICE VOLO HOT - Spinal Landing severe spondylolisthesis (Grade 3) who are having the fixation system, is indicated for use in pations: a) na nig consums graft only, a) who are having the daving the daying tempyed at the LS-5 I Joint, by Milo are receiving rusing and d) who are having the device removed device fixed of allached to the lambal of bactar spans, and cation, the fisses I 2 to the secom atter the development of a sold fusion mass. "Then assuration may span from L3 to the sacrum.
The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a pedicle screw system The Spinal Innovations RE VOLOTION - Upinal Profital segments in sketetally mature patients
intended to provide immobilization and stabilization of spinal instabilities or intended to provide initifoomization and the following acute and chromic instabilities of as an adjunct to fusion in the treatment of the idegenerative spondylolisthesis with objectives, and deformities of the thoracic, fracture, and sucral spire. Segmentliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a hook and sacral screw system (other than pedicle screw fixation system for high When used as a nook and sacral serew system (GEVOLUTION TM Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of intended for use in the treatment of degeneration of the discory and radiographic studies of seatility, dissogenic origin with the degoneration or the one ordotic deformity of the spine, loss of stability idiopathic scollosis, spolloyfolishesis, typical or dislocation, pseudoarthrosis, and previous failed due to tunfors, spinal stonosis, verter this indication, screws of the Spinal Innovations spinal surgety/lusion. When used for this intended for sacral/iliac atachment only. Hooks of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook the system are w fixation of this system are T1 to the sacrum.
Testing
Biomechanical testing demonstrated that the components of the Spinal Innovations REVOLUTION Biomechanical testing demonstrated that the complex.
TM Spinal Fixation System exhibit equivalent mechanical performance compared to predicate devices. Testing included the following:
-
- Interconnection testing of individual system components per ASTM F 1798-97. The testing Intercomection resultig of maividual system components per raxion/extension static and fatigue testing.
Testing results of the various system components show that the data compares directly to precity the Testing results of the various system oomponents bab it sees. Therefore, the results support that the device testing and meets of exceeds only procruite as a convalent to the predicate devices.
- Interconnection testing of individual system components per ASTM F 1798-97. The testing Intercomection resultig of maividual system components per raxion/extension static and fatigue testing.
Basis for Substantial Equivalence
The Spinal Innovations REVOLUTION ™ Spinal Fixation System is substantially equivalent in material, design and function to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Mr. Joseph S. Clift Vice President, Regulatory Affairs Spinal Innovations, Inc. 7850 Stage Hill Boulevard, Suite 105 Bartlett, Tennessee 38133
Rc: K032219
Trade Name: Spinal Innovations REVOLUTION" Spinal Fixation System Regulatory Number: 21 CFR 888.3070, 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWP Dated: October 28, 2003 Received: November 28, 2003
Dear Mr. Clift:
We have reviewed your Scction 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.
3
Page 2 - Mr. Joseph S. Clift
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 Office of Compliance at (301) 594-4639. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
Mark A. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO32219 510(K) Number
Device Name: Spinal Innovations REVOLUTION ™ Spinal Fixation System
Indications for Use:
The Spinal Innovations REVOLUTION ™ Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a pedicle screw system 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).
When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations REVOLUTION ™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degencration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations REVOLUTION ™ Spinal Fixation System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are TI to the sacrum.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Over-The-Counter Use OR
for Mark-N Millman (Opti
Optional Format 1-2-96)
ision Sign-Off)
Division of General, Rest
and Neurological Devices