(93 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its instruments. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical testing and clinical literature review, not algorithmic performance.
Yes.
The device is a spinal fixation system intended to stabilize the spine as an adjunct to fusion for a variety of conditions, which is a therapeutic purpose.
No
The Polaris Spinal System is described as a "non-cervical spinal fixation device" intended for "immobilization and stabilization as an adjunct to fusion." It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a spinal fixation device made from various metal alloys and includes physical components like screws, rods, and hooks. It also mentions instruments for implantation. This is a hardware medical device.
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 such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Polaris Spinal System is a surgical implant used for spinal fixation. It is a physical device implanted into the body to provide structural support and stabilization.
- Lack of Biological Sample Analysis: The description and intended use do not mention any analysis of biological samples from the patient. The device's function is mechanical and structural, not diagnostic based on biological markers.
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, kyphosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista/Ballista II instruments are intended to be used with Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris 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, Nextgen Altius 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 (comma separated list FDA assigned to the subject device)
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 F 136, unalloyed titanium per ASTM F 67, stainless steel per ASTM F 138 or ASTM F 1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM 1537. The system includes screws, various types and sizes of rods, locking nuts, hooks. lateral connectors, plugs. fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This line extension is to expand the indications for use for Polaris Spinal System using previous cleared system components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, non-cervical
Indicated Patient Age Range
Pediatric patients, adolescent
Intended User / Care Setting
Surgeon
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)
The implants included in the submission were previously tested for static compression bending, static torsion and dynamic compression bending per ASTM F1717. Because the system's mechanical strength has already been demonstrated, additional testing is not required to demonstrate substantial equivalence for expanded indications and an engineering rationale was provided.
To support substantial equivalence, a clinical literature assessment was conducted using published clinical data for pedicle screw fixation for adolescent idiopathic scoliosis. The assessment concluded that pedicle screw fixation is safe and effective for use in pediatric patients for the treatment of adolescent idiopathic scoliosis.
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.
K113395, K091445, K111457, K113395, K110070, K123549, K090203
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
Image /page/0/Picture/1 description: The image shows the logo for Biomet Spine. The logo is in black and white, with the word "BIOMET" in large, bold letters. Below the word "BIOMET" is the word "SPINE" in smaller letters. The logo is simple and clean, and it is likely used to represent the company's brand.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | May 31, 2013 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 399 Jefferson Road | |
| Parsippany, NJ 07054 | |
| Contact Person: | Vivian Kelly |
| Regulatory Affairs Project Manager | |
| Phone: 973-299-9300 x2214 | |
| Fax: 973-887-1347 | |
| Trade name: | Polaris Spinal System |
| Common Name: | Non-cervical spinal fixation system |
| 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 F 136, unalloyed titanium per ASTM F 67, stainless steel per ASTM F 138 or ASTM F 1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM 1537. The system includes screws, various types and sizes of rods, locking nuts, hooks. lateral connectors, plugs. fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This line extension is to expand the indications for use for Polaris Spinal System using previous cleared system components.
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, kyphosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista/Ballista II instruments are intended to be used with Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
1
For pediatric patients, the Polaris 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, Nextgen Altius 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 Polaris Spinal System remain the same as, or similar to. the predicate devices in regards to intended use, indications, design, materials, manufacturing methods, sterility, fundamental technology, and operational principles.
Performance Data:
The implants included in the submission were previously tested for static compression bending, static torsion and dynamic compression bending per ASTM F1717. Because the system's mechanical strength has already been demonstrated, additional testing is not required to demonstrate substantial equivalence for expanded indications and an engineering rationale was provided.
To support substantial equivalence, a clinical literature assessment was conducted using published clinical data for pedicle screw fixation for adolescent idiopathic scoliosis. The assessment concluded that pedicle screw fixation is safe and effective for use in pediatric patients for the treatment of adolescent idiopathic scoliosis.
Substantial Equivalence:
The Polaris Spinal System is substantially equivalent to the Revere" 4.5 Stabilization System, Globus Medical Inc. (K113395), the CD Horizon" Spinal System. Medtronic (K091445. K111457 & K 113395) and the TSRH* Spinal System, Medtronic (K 110070) for pediatric pedicle screw use and the Polaris Spinal System (K123549 & K090203) in regards to material, design and operational principles.
Conclusion:
The Polaris Spinal System is substantially equivalent to the predicate systems as spinal fixation devices in regards intended use, indications, design, materials, manufacturing methods, sterility, fundamental technology, and operational principles. Furthermore, preclinical data, the clinical literature assessment review and other supporting information sufficiently demonstrate the substantial equivalence of the subject device to the Polaris Spinal System and the other named predicate systems, which have been cleared for pedicle screw fixation for adolescent idiopathic scoliosis. Scheuermann's Disease, and spondylolysis.
2
Image /page/2/Picture/0 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" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.
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
September 4, 2013
Biomet Spine Ms. Vivian Kelly Regulatory Affairs Project Manager 399 Jefferson Road Parsippany, New Jersey 07054
Re: K131615
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: August 12, 2013 Received: August 15, 2013
Dear Ms. Kelly:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Vivian Kelly
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K131615
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 radiouraphic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, Schevermann's disease, and/or lordosis.), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista/Ballista II instruments are intended to be used with Ballista/Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/Ballista II instruments to provide the surgeon with a perculaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to freat adolescent idiopathic scolinsis 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, Nextgen Altius 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 N (Part 21 CFR 801 Subpart D)
ANDAOR
()ver-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)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthonedic Devices 510(k) Number: K131615