(265 days)
No
The summary describes a mechanical orthopedic plating system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for fixation of fractures, revision procedures, and joint fusion, which are therapeutic interventions.
No
The device is a plating system intended for fixation of fractures and reconstruction, which are treatment procedures, not diagnostic ones. It does not perform any assessment, diagnosis, or detection of disease or conditions.
No
The device description explicitly states it consists of multiple plate families, screws, and instruments, which are physical hardware components.
No, 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, tissue) to provide information about a person's health.
- Device Description: The Pantheon Medical Balanced Plating System is described as a system of plates, screws, and instruments intended for the surgical fixation of bones. This is a surgical implant and instrument system, not a device that analyzes biological samples.
- Intended Use: The intended use is for "fixation of fractures, revision procedures, joint fusion, non-unions, and reconstruction of orthopedic small bone extremities." This is a direct surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly indicates this is a device used within the body during surgery, not a device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The Pantheon Medical Balanced Plating System is intended for fixation of fractures, revision procedures, joint fusion, non-unions, and reconstruction of orthopedic small bone extremities. This system is not intended for spinal use.
Product codes
HRS, HWC
Device Description
The Pantheon Medical Balanced Plating System consists of multiple plate families of various anatomical sizes and shapes, 2.7mm and 3.5mm locking and non-locking screws which mate into the plates, as well as a 4.0mm compression screw that is utilized with the Lapidus plate. Various instruments are also included to assist in implanting the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopedic small bone extremities
Indicated Patient Age Range
Not Found
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)
Non-Clinical Performance Data Summary:
- ASTM F-543
- ASTM F-382
Clinical Performance Data Summary:
No clinical testing was required.
Non-Clinical and Clinical Performance Data Conclusions:
Based on testing results and the comparisons provided, the Pantheon Medical Balanced Plating System are considered substantially equivalent to the Mondeal Extremity Bone Fixation System in material, construction, and performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "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, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2017
Panatheon Medical % Lee Strnad Management Representative Intrepid Orthopedics 3046 Brecksville Rd. Ste 4 Richfield, OH 44286
Re: K162154
Trade/Device Name: Panatheon Medical Balanced Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 1, 2017 Received: April 3, 2017
Dear Mr. Strnad:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162154
Device Name
Pantheon Medical Balanced Plating System
Indications for Use (Describe)
The Pantheon Medical Balanced Plating System is intended for fixation of fractures, revision procedures, joint fusion, non-unions, and reconstruction of orthopedic small bone extremities. This system is not intended for spinal use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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05. 510(k) Summary
Submitter Information
Applicant: Pantheon Medical 1505 Federal Street, Suite 300 Dallas, Texas 75201
- Contact Person: Lee A. Strnad Management Representative Intrepid Orthopedics 3046 Brecksville Rd, Ste 4 Richfield, OH 44286 (330) 659-0855
- Date Prepared: 4/18/17
- Name of Device: Pantheon Medical Balanced Plating System
- Common Name: Bone Fixation Plate
Classification Name Single/Multiple component metallic bone fixation appliances and accessories (per 21 CFR 888.3030), Smooth or threaded metallic bone fixation fastener (per 21 CFR 888.3040)
- HRS/Orthopedics, HWC Product Code/Panel:
- Predicate Devices: Mondeal Extremity Bone Fixation System (K072740), Mondeal CONTOUR HO System (K050657)
Intended Use:
The Pantheon Medical Balanced Plating System is intended for fixation of fractures, revision procedures, joint fusion, non-unions, and reconstruction of orthopedic small bone extremities. This system is not intended for spinal use.
Device Description
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05. 510(k) Summary
The Pantheon Medical Balanced Plating System consists of multiple plate families of various anatomical sizes and shapes, 2.7mm and 3.5mm locking and non-locking screws which mate into the plates, as well as a 4.0mm compression screw that is utilized with the Lapidus plate. Various instruments are also included to assist in implanting the system.
Technological Characteristics
The Pantheon Medical Balanced Plating System have the same intended use as the predicate devices. The Pantheon Medical Balanced Plating System have similar indications for use as the predicate devices. The Pantheon Medical Balanced Plating System are manufactured from the same materials as the predicate devices. Pantheon Medical Balanced Plating System implants are manufactured from Ti-6Al-4V per ASTM F-136. The range of sizes of the Pantheon Medical Balanced Plating System are similar to the predicate devices.
Non-Clinical Performance Data Summary
- ASTM F-543 2. ASTM F-382
Clinical Performance Data Summary
No clinical testing was required.
Non-Clinical and Clinical Performance Data Conclusions
Based on testing results and the comparisons provided, the Pantheon Medical Balanced Plating System are considered substantially equivalent to the Mondeal Extremity Bone Fixation System in material, construction, and performance characteristics.