(56 days)
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No
The device description is solely focused on the physical characteristics and material of an intramedullary rod for ankle fusion, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is an intramedullary rod for ankle fusions, which is an implant for structural support, not a therapeutic device that delivers therapy or treats a condition beyond structural support.
No
Explanation: The device description clearly states it is an "intramedullary rod" used for "tibiocalcaneal arthrodesis procedures (ankle fusions)," indicating it is an implantable surgical device, not a diagnostic one.
No
The device description clearly states it is an "intramedullary rod" made of metal, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tibiocalcaneal arthrodesis procedures (ankle fusions)". This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is an "intramedullary rod" made of titanium alloy, designed to be implanted within the bone. This is a surgical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The description of the Polarus AF Rod does not mention any interaction with biological specimens or diagnostic testing.
Therefore, the Polarus AF Rod is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Polarus AF Rod is an intramedullary rod which addresses tibiocalcaneal arthrodesis procedures (ankle fusions).
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Polarus AF Rod is an intramedullary rod which addresses tibiocalcaneal arthrodesis procedures (ankle fusions). The rod's dimensions are 11 mm x 150 mm and it is interlocked in place by 4.5 mm cortical screws.
The Polarus AF Rod is manufactured from 6AL/4V ELI per ASTM F 136. This device is provided pre-sterile. Sterility is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 104. Information regarding implantation, packaging, and labeling have been provided.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tibiocalcaneal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the letters 'FCB' in a bold, sans-serif font. The letters are large and take up a significant portion of the image. The letters are black against a white background.
K962∅91
JU 24 K
Quality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
The Polarus AF Rod is an intramedullary rod which addresses tibiocalcaneal arthrodesis procedures (ankle fusions). The rod's dimensions are 11 mm x 150 mm and it is interlocked in place by 4.5 mm cortical screws.
The Polarus AF Rod is manufactured from 6AL/4V ELI per ASTM F 136. This device is provided pre-sterile. Sterility is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 104. Information regarding implantation, packaging, and labeling have been provided.
The Polarus AF Rod is similar to Smith & Nephew Richards, Inc.'s Intramedullary Rod in design, function, indications and surgical technique and is expected to perform as well as similar devices.