(104 days)
Not Found
No
The summary describes a mechanical implant system and its mechanical testing, with no mention of AI or ML.
Yes
The device is described as an intramedullary nail system used for the stabilization and fixation of small bones in the feet and ankle to treat various conditions like fractures, nonunions, and malunions. This falls under the definition of a therapeutic device as it is used to treat or alleviate a medical condition.
No
Explanation: The device is an intramedullary nail system used for the fixation and stabilization of small bones, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly states it is comprised of physical components: intramedullary nails, locking screws, threaded pegs, and instruments for implantation. This indicates it is a hardware medical device, not software-only.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Phantom™ Small Bone Intramedullary Nail System is comprised of "small bone intramedullary nails, locking screws and threaded pegs" and "instruments for implantation." These are physical implants and surgical tools used within the body.
- Intended Use: The intended use describes the device's function in "stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures." This is a surgical intervention, not a diagnostic test performed on a sample.
The device is an implantable medical device used for orthopedic surgery.
N/A
Intended Use / Indications for Use
The Phantom™ Small Bone Intramedullary Nail System is indication and fixation of the small bones of the feet and ankle for the treatment of fractures, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.
Product codes (comma separated list FDA assigned to the subject device)
KTW, HWC
Device Description
The PhantomTM Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The PhantomTM nails are offered in a variety of lengths to accommodate variations in patient anatomy. The PhantomTM threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the feet and ankle
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)
Mechanical testing of the worst case PhantomTM nail included static and dynamic bending performed according to ASTM F382. Mechanical testing of the worst case PhantomTM locking screw and threaded peg included torsion, insertion/removal and pullout performed according to ASTM F543. The mechanical test results and predicate comparisons demonstrated that the mechanical performance of the Small Bone Intramedullary Nail System is substantially equivalent to the predicate.
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.
ParaLock Plating SystemTM (Paragon 28, Inc. – K140397)
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
§ 888.3030 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/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a simple text block with the address information.
June 19, 2017
Paragon 28, Inc. % Karen Warden Representative/Consultant BackRoads Consulting. Inc PO Box 566 Chesterland, Ohio 44026-0566
Re: K170693
Trade/Device Name: Phantom Small Bone Intramedullary Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTW, HWC Dated: March 6, 2017 Received: March 7, 2017
Dear Karen Warden:
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
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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 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/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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170693
Device Name Phantom™ Small Bone Intramedullary Nail System
Indications for Use (Describe)
The Phantom™ Small Bone Intramedullary Nail System is indication and fixation of the small bones of the feet and ankle for the treatment of fractures, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary | |
|---|---|
| Date: | 6 March 2017 |
| Sponsor: | Paragon 28, Inc. |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888, Facsimile: (888) 728-1220 | |
| Sponsor Contact: | Frank S. Bono, Chief Technology Officer |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Names: | PhantomTM Small Bone Intramedullary Nail System |
| Common Name: | Combination nail/plate |
| Regulatory Class: | Class II |
| Classification Name, | |
| Regulation, Product | |
| Code: | Appliance, fixation, nail/blade/plate combination, single component, |
| 888.3030, KTW | |
| Screw, Fixation, Bone, 888.3040, HWC | |
| Device Description: | The PhantomTM Small Bone Intramedullary Nail System is comprised of |
| small bone intramedullary nails, locking screws and threaded pegs. The | |
| PhantomTM nails are offered in a variety of lengths to accommodate | |
| variations in patient anatomy. The PhantomTM threaded pegs and locking | |
| screws insert through the intramedullary nail to secure the construct. | |
| These are offered in varying lengths to accommodate the anatomical | |
| fixation required. The system includes instruments for implantation. | |
| Indications for Use: | The PhantomTM Small Bone Intramedullary Nail System is indicated for |
| use in stabilization and fixation of the small bones of the feet and ankle | |
| for the treatment of fractures, osteotomies, nonunions, pseudarthroses | |
| and malunions by revision, joint fusion or reconstruction procedures. | |
| Materials: | The PhantomTM Small Bone Intramedullary Nail System implants are |
| manufactured from medical grade titanium alloy (per ASTM F136). | |
| Primary Predicate: | ParaLock Plating SystemTM (Paragon 28, Inc. – K140397) |
| Performance Data: | Mechanical testing of the worst case PhantomTM nail included static and |
| dynamic bending performed according to ASTM F382. Mechanical testing | |
| of the worst case PhantomTM locking screw and threaded peg included | |
| torsion, insertion/removal and pullout performed according to ASTM | |
| F543. The mechanical test results and predicate comparisons | |
| demonstrated that the mechanical performance of the Small Bone | |
| Intramedullary Nail System is substantially equivalent to the predicate. | |
| Technological | |
| Characteristics: | The PhantomTM Small Bone Intramedullary Nail System possesses |
| similar technological characteristics compared to the predicate device. | |
| These include: | |
| performance,basic design,material, manufacturing andsizes (dimensions are comparable to those offered by the | |
| predicate systems).The difference in the stabilization method between the subject and | |
| predicate devices, i.e., combination nail/plate versus plate, did not raise | |
| new questions of safety or effectiveness. Therefore the fundamental | |
| scientific technology of the Phantom™ Small Bone Intramedullary Nail | |
| System is substantially equivalent to previously cleared devices. | |
| Conclusion: | The Phantom™ Small Bone Intramedullary Nail System possesses |
| indications for use and technological characteristics the same as and | |
| similar to the predicate devices. Therefore the Phantom™ Small Bone | |
| Intramedullary Nail System is substantially equivalent to the predicates. |
510(k) Summary
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