(48 days)
No
The summary describes a mechanical spinal fixation device and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended to correct severe, progressive, life-threatening, early-onset spinal deformities, which is a therapeutic purpose.
No
The device is a non-cervical spinal fixation device used for surgical treatment to correct spinal deformities; it is not described as being used to diagnose conditions.
No
The device description explicitly states it is a non-cervical spinal fixation device made from titanium alloy and cobalt chrome alloy, which are 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: The Polaris Spinal Growth System is a physical implantable device made of titanium and cobalt chrome alloys. It is a surgical device used to treat spinal deformities.
- Intended Use: The intended use describes a surgical procedure to correct spinal deformities in young patients. It does not involve testing biological samples.
The device is a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Polaris Spinal Growth System is indicated in patients with potential growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.
The Polaris Spinal Growth System may be used with any cleared traditional Polaris Spinal System construct, including any cleared Polaris Spinal System compatibilities.
Product codes
PGM
Device Description
The Polaris Spinal Growth System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system is comprised of Growth Connectors which are intended to be used with the Polaris Spinal System implants and instruments. The design and size offerings of the Polaris Spinal Growth System connectors are identical to those currently available in the Polaris Spinal System but are indicated for growth rod constructs. These growth rod constructs typically require repeated plannedlengthening procedures until a determination is made that the patient is ready for a final fusion procedure. After the spine is fused, these devices serve no functional purpose and may be removed.
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
under 10 years of age
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)
To support substantial equivalence, mechanical testing of the Polaris Spinal Growth System constructs were assessed and tested in accordance with ASTM F1717 and ASTM F1798. Performance testing included tests per ASTM F1798 (axial grip strength, torsional grip strength, and flexion/extension moment grip strength) and ASTM F1717 (static compression bending, dynamic compression bending, and static torsion). In all instances, the Polaris Spinal Growth System functioned as intended, meeting the acceptance criteria.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2022
Zimmer Biomet Spine, Inc. Anthony Maahs Regulatory Affairs Specialist 10225 Westmoor Drive Westminster, Colorado 80021
Re: K180227
Trade/Device Name: Polaris Spinal Growth System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGM
Dear Anthony Maahs:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 15, 2018. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 21 CFR 888.3070.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ronald Jean, OHT6: Office of Orthopedic Devices, (301)796-5650, Ronald.Jean@fda.hhs.gov
Sincerely,
Ronald P. Jean -S
Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 15, 2018
Zimmer Biomet Spine, Inc. Mr. Anthony Maahs Regulatory Affairs Specialist 10225 Westmoor Drive Westminster, Colorado 80021
Re: K180227
Trade/Device Name: Polaris Spinal Growth System Regulatory Class: Unclassified Product Code: PGM Dated: January 25, 2018 Received: January 29, 2018
Dear Mr. Maahs:
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K180227
Device Name Polaris Spinal Growth System
Indications for Use (Describe)
The Polaris Spinal Growth System is indicated in patients with potential growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.
The Polaris Spinal Growth System may be used with any cleared traditional Polaris Spinal System construct, including any cleared Polaris Spinal System compatibilities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color, contrasting with the white background.
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 | March 13, 2018 |
|---|---|
| Applicant/Sponsor | Zimmer Biomet Spine, Inc. |
| 10225 Westmoor Dr. | |
| Westminster, CO 80021 | |
| Contact Person | Anthony Maahs |
| Regulatory Affairs Specialist | |
| Phone: 303-465-8923 | |
| Fax: 303-501-8444 | |
| Trade Name | Polaris Spinal Growth System |
| Common Name | Growing Rod System |
| Device Class | Unclassified |
| Classification Name | PGM - Growth Rod System |
| Device Panel | Orthopedic |
Device Description & Technological Characteristics:
The Polaris Spinal Growth System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system is comprised of Growth Connectors which are intended to be used with the Polaris Spinal System implants and instruments. The design and size offerings of the Polaris Spinal Growth System connectors are identical to those currently available in the Polaris Spinal System but are indicated for growth rod constructs. These growth rod constructs typically require repeated plannedlengthening procedures until a determination is made that the patient is ready for a final fusion procedure. After the spine is fused, these devices serve no functional purpose and may be removed.
5
Image /page/5/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray color, contrasting with the white background.
Intended Use / Indications for Use:
The Polaris Spinal Growth System is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.
The Polaris Spinal Growth System may be used with any cleared traditional Polaris Spinal System construct, including any cleared Polaris Spinal System compatibilities.
Summary of Technological Characteristics:
The technological characteristics, in regards to design, manufacturing methods, fundamental technology, and operational principles, of the subject Polaris Spinal Growth System components remain identical to those described in their clearance as part of the Polaris Spinal Fixation System (K133746). The purpose of this 510(k) Premarket Notification is to seek clearance for the Polaris Spinal Growth System to be used in pediatric growth application with patients under 10 years of age.
Summary of Performance Data:
To support substantial equivalence, mechanical testing of the Polaris Spinal Growth System constructs were assessed and tested in accordance with ASTM F1717 and ASTM F1798. Performance testing included tests per ASTM F1798 (axial grip strength, torsional grip strength, and flexion/extension moment grip strength) and ASTM F1717 (static compression bending, dynamic compression bending, and static torsion). In all instances, the Polaris Spinal Growth System functioned as intended, meeting the acceptance criteria.
Predicate Devices:
Predicate Device: CD Horizon® Growth Rod Conversion Set (K133904) Reference Device: Polaris Spinal System (K151974)
Substantial Equivalence Conclusion:
The Polaris Spinal Growth System is substantially equivalent to the predicate systems in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. The mechanical testing results support this conclusion as they demonstrate that the Polaris Spinal Growth System is able to fulfill its intended use: non-cervical spinal growth and fixation. Based on this information, the subject device does not raise any new issues regarding safety or efficacy when compared to the predicate system.