(120 days)
No
The 510(k) summary describes a mechanical spinal fixation system and its instruments. There is no mention of AI, ML, image processing, or any software component that would suggest the use of such technologies. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is a spinal fixation system intended for immobilization as an adjunct to fusion for a variety of spinal conditions, which directly addresses therapeutic goals.
No
The Polaris Spinal System is a spinal fixation device, an implant used to provide stability to the spine as an adjunct to fusion. Its purpose is mechanical support and stabilization, not the diagnosis of medical conditions.
No
The device description explicitly states it is a spinal fixation device made from various metal alloys and includes screws, rods, nuts, hooks, and other physical components. It also mentions instruments for implantation and mechanical testing of these physical components.
Based on the provided text, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Polaris Spinal System is a physical implantable device (screws, rods, hooks, etc.) used for spinal fixation and fusion. It is surgically implanted into the body to provide structural support.
- No Mention of Testing on Samples: The description and intended use do not involve analyzing samples from the body or providing diagnostic information based on such analysis.
Therefore, the Polaris Spinal System falls under the category of a surgical implant or orthopedic 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 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. 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, tracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuerman's disease, and/or lordosis,), tumor, stenosis, pseudarthrosis, 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 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 dominoes 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, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. Various instruments are also available for use by the surgeon to facilitate implantation of the device. The purpose of this Premarket Notification is to add modified Ø4.75mm multi-axial screws.
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
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 turnor and/or trauma.
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 May 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 and modified flexion-extension testing per ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies used in Spinal Arthrodesis Implants. 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)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2015
Biomet Spine Ms. Alexandra Beck Regulatory Affairs Specialist 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021
Re: K151974
Trade/Device Name: Polaris Spinal System 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: October 27, 2015 Received: October 28, 2015
Dear Ms. Beck:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Alexandra Beck
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/Resourcesfor You/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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Polaris Spinal System
Indications for Use (Describe)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization 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. 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, tracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuerman's disease, and/or lordosis,), tumor, stenosis, pseudarthrosis, 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 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 dominoes 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | November 12, 2015 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 310 Interlocken Parkway, Suite 120 | |
| Broomfield, CO 80021 | |
| Contact Person: | Alexandra Beck |
| Regulatory Affairs Specialist | |
| Phone: 303-501-8397 | |
| Fax: 303-501-8444 | |
| Trade name: | Polaris Spinal System |
| Common Name: | Non-cervical spinal fixation system |
| Device Class: | Class II & III Pre-amendment |
| Classification Name: | Orthosis, Spinal Pedicle Fixation, for Degenerative Disc Disease (NKB) |
| Class III pre-amendment device per 21 CFR 888.3070 | |
| Appliance, Fixation, Spinal Interlaminal (KWP) | |
| Class II per 21 CFR 888.3050 | |
| Appliance, Fixation, Spinal Intervertebral Body (KWQ) | |
| Class II per 21 CFR 888.3060 | |
| Orthosis, Spondylolisthesis Spinal Fixation (MNH) | |
| Class II per 21 CFR 888.3070 | |
| Orthosis, Spinal Pedicle Fixation (MNI) | |
| Class II per 21 CFR 888.3070 | |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH) | |
| Class II per 21 CFR 888.3070 | |
| Device Panel: | Orthopedic |
| Primary Predicate: | Polaris Spinal System – K133746 |
| Reference Device: | Polaris Spinal System - K090203 |
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, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. Various instruments are also available for use by the surgeon to facilitate implantation of the device. The purpose of this Premarket Notification is to add modified Ø4.75mm multi-axial screws.
4
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 turnor 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 dominoes 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 device 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 May 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 and modified flexion-extension testing per ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies used in Spinal Arthrodesis Implants. 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 subject Polaris Spinal System is substantially equivalent to the Polaris Spinal System (K133746).
5
Conclusion:
The Polaris Spinal System is substantially equivalent to the predicate system as a spinal fixation device 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 device does not raise any new issues regarding the safety or efficacy when compared to its predicates.