(98 days)
Not Found
No
The document describes a mechanical spinal fixation 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, not algorithmic performance evaluations.
Yes
The device is a spinal fixation system intended for immobilization and stabilization as an adjunct to fusion, which directly treats various spinal conditions like degenerative disc disease, spondylolisthesis, and scoliosis.
No
Explanation: The Polaris Spinal System is a spinal fixation device intended for immobilization and stabilization as an adjunct to fusion. Its purpose is to treat conditions like degenerative disc disease, spondylolisthesis, and trauma by providing structural support, not by diagnosing them.
No
The device description explicitly states that the Polaris Spinal System is made from various metal alloys and includes physical components such as screws, rods, nuts, and connectors. This indicates it is a hardware-based medical device, not software-only.
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 Polaris Spinal System is a physical implantable device used for spinal fixation and stabilization during surgery. It is a mechanical device used in vivo (within the body) to support the spine.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to provide diagnostic information. Its purpose is structural support and stabilization.
Therefore, the Polaris Spinal System falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista and Cypher MIS instruments are intended to be used with Ballista/ Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.
The Polaris Soinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
Product codes
NKB, OSH, MNI, MNH, KWP, KWQ
Device Description
The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to clear modifications to Polaris Translation Screw and to update the labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal
Indicated Patient Age Range
pediatric 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 was conducted in accordance with FDA's Guidance for Industry and FDA Staff -- Spinal System 510(k)s dated Mav 3. 2004. Per the guidance document, the following testing was conducted: static compression bending, static torsion, and dynamic compression bending fatigue per ASTM F1717. Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model. Additional verification testing was conducted to compare the ability of the subject device to resist cantilever loading or non-axial torque as compared to the predicate device. The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market for its intended use and has met all mechanical test requirements based on the worst-case construct testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K131615, K123549, K090203, K061441
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
APR 2 4 2014
Image /page/0/Picture/2 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font. Below it, in a smaller font, is the word "SPINE". The logo is black and white.
510(k) Summar
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | April 22, 2014 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 399 Jefferson Road | |
| Parsippany, NJ 07054 | |
| Contact Person: | Mike Medina |
| Senior Manager, Regulatory Affairs | |
| Phone: 303-501-8548 | |
| Fax: 303-501-8444 | |
| Trade name: | Polaris Spinal System -Translation Screw |
| Common Name: | Non-cervical spinal fixation system |
| Device Class: | Class III |
| Classification Name | |
| (Product Code): | Posterior, noncervical, nonpedicle use (KWP) |
| Anterior/anterolateral noncervical use (KWQ) | |
| Noncervical pedicle applications (MNI, MNH and NKB) | |
| Pedicle screw spinal system, adolescent idiopathic scoliosis (OSH) |
Device Panel - Regulation No .: Orthopedic - 21 CFR 888.3050. 888.3060 and 888.3070
Device Description:
The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to clear modifications to Polaris Translation Screw and to update the labeling.
Indications for Use:
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista and Cypher MIS instruments are intended to be used with Ballistal Cypher MIS/ Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the
1
Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients. the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT. Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
Summary of Technologies:
The technological characteristics of the subject Polaris Spinal System components remain the same as, or similar to, the predicate devices in regards to intended use, indications for use, design, materials, manufacturing methods, sterility, fundamental technology, and operational principles.
Performance Data:
Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff -- Spinal System 510(k)s dated Mav 3. 2004. Per the guidance document, the following testing was conducted: static compression bending, static torsion, and dynamic compression bending fatigue per ASTM F1717. Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model. Additional verification testing was conducted to compare the ability of the subject device to resist cantilever loading or non-axial torque as compared to the predicate device. The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market for its intended use and has met all mechanical test requirements based on the worst-case construct testing.
Substantial Equivalence:
The modified Polaris Translation Screw in the Polaris Spinal System is substantially equivalent to the Polaris Spinal System (K131615, K123549, K090203, and K061441) in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles.
Conclusion:
The Polaris Translation Screw is substantially equivalent to the predicate systems as spinal fixation devices in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the Polaris Spinal System. which has been cleared for a non-cervical spinal fixation. Based on this information, the subject modifications do not raise any new issues regarding the safety or efficacy when compared to its predicates.
2
Image /page/2/Picture/0 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter, with the words separated by small dots.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2014
Biomet Spine Mr. Mike Medina Senior Manager, Regulatory Affairs 399 Jefferson Road Parsippany, New Jersey 07054
Re: K140123
Trade/Device Name: Polaris Spinal System - Translation Screw Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP, KWQ Dated: March 26, 2014 Received: March 27, 2014
Dear Mr. Medina:
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. 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 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Mike Medina
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
:
Sincerely yours,
Lori A. Wiggins
- ·for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Biomet Spine Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): _K140123
Device Name: Polaris Spinal System
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista and Cypher MIS instruments are intended to be used with Ballista/ Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.
The Polaris Soinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
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 Center for Devices and Radiological Health (CDRH)
James P. Bertram 2014.04.23 15:16:06 -04'00'
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140123