(28 days)
No
The document describes a line extension to a spinal fixation system, focusing on additional screw and rod sizes. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "Spinal System" intended to address various spinal conditions (e.g., degenerative disc disease, spondylolisthesis, trauma, scoliosis, tumor) to achieve fixation, indicating its role in treating and managing a medical condition.
No
The MANTIS Spinal System is described as a system for posterior, non-cervical pedicle fixation to treat various spinal conditions, not to diagnose them. It's a line extension (screws and rods), indicating its function as a treatment device, not a diagnostic one.
No
The device description clearly states it is a "Spinal System" and includes physical components like "cannulated polyaxial screw components" and "straight rod components," indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MANTIS® Spinal System is for "posterior, non-cervical pedicle fixation" for various spinal conditions. This describes a surgical implant used in vivo (within the body) to stabilize the spine.
- Device Description: The description details screws and rods, which are physical components implanted during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests on biological samples.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications; degenerative disc disease (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.
Product codes
87 MNH, 87 MNI, 87 NKB
Device Description
This Special 510(k) submission is intended to introduce a line extension to the MANTIS Spinal System, which entails additional diameter size cannulated polyaxial screw components as well as additional straight rod components in a variety of lengths. Modifications were made to the existing MANTIS Spinal System (K061813) to render the new components. The MANTIS Spinal System will include cannulated polyaxial screw, pre-bent rod and straight rod components that can be used via either a percutaneous surgical approach or a standard open approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical pedicle
Indicated Patient Age Range
Not Found
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
Testing has demonstrated that the additional screw and rod components have equivalent mechanical properties to the predicate Stryker Spine Xia Titanium Spinal System screws and rod components and the Stryker Spine Osteonics Spinal System.
Key Metrics
Not Found
Predicate Device(s)
K061813, K013823, K043473, K002858, K060361, K951725
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
| | Special 510(k) Summary:
MANTIS® Spinal System | K073151 |
|----------------------------|--------------------------------------------------|-------------|
| Proprietary Name: | MANTIS® Spinal System | |
| Common Name: | Spinal Fixation Appliances | DEC 16 2007 |
| Proposed Regulatory Class: | Class III | |
| | Pedicle Screw Spinal System, 21 CFR 888.3070 | |
| Device Product Code: | 87 MNH: Spondylolisthesis Spinal Fixation System | |
| | 87 MNI: Orthosis, Spinal, Pedicle Fixation | |
| | 87 NKB: Orthosis, Spinal Pedicle Fixation, for | |
| | Degenerative Disc Disease | |
| For Information contact: | Curtis Truesdale | |
| | Regulatory Affairs Project Manager | |
| | 2 Pearl Court | |
| | Allendale, NJ 07401 | |
| | Telephone: (201) 760-8029 | |
| | Fax: (201) 760-8229 | |
| | Email: curtis.truesdale@stryker.com | |
| Date Summary Prepared: | October 18, 2007 | |
Predicate Device Identification
The predicate device is the existing Stryker Spine MANTIS Spinal System (Cleared through 510(k) #K061813), Stryker Spine Xia® Titanium Spinal System (cleared through 510(k) #K013823, #K043473, K002858, K060361) and Stryker Spine Osteonics Spinal System (cleared through 510(k) #K951725).
Description of Device Modification
This Special 510(k) submission is intended to introduce a line extension to the MANTIS Spinal System, which entails additional diameter size cannulated polyaxial screw components as well as additional straight rod components in a variety of lengths. Modifications were made to the existing MANTIS Spinal System (K061813) to render the new components. The MANTIS Spinal System will include cannulated polyaxial screw, pre-bent rod and straight rod components that can be used via either a percutaneous surgical approach or a standard open approach.
1
Intended Use:
The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications; degenerative disc disease (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.
Statement of Technological Comparison:
Testing has demonstrated that the additional screw and rod components have equivalent mechanical properties to the predicate Stryker Spine Xia Titanium Spinal System screws and rod components and the Stryker Spine Osteonics Spinal System. Both the new components and the existing system components of the MANTIS are intended to address the same indications for use. Both the new components and the existing components of MANTIS System are made from the same materials.
2
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2007
Stryker Instruments % Stryker Spine Mr. Curtis Truesdale 2 Pearl Court Allendale, NJ 07401
Re: K073151
Trade/Device Name: Mantis Spinal System Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNH, MNI Dated: November 7, 2007 Received: November 8, 2007
Dear Mr. Truesdale:
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.
3
Page 2 - Mr. Curtis Truesdale
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 vours.
Mark N. Mullerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MANTIS® Spinal System, Line Extension
Indications for Use
073/5/ 510(k) Number (if known):
Device Name: MANTIS® Spinal System, Line Extension
Indications for Use:
The MANTIS® Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (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.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milham
ivision Sign-Off) ( vision of General, Restorative, & Id Neurological Devices
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