(72 days)
Not Found
No
The provided text describes a mechanical implant system (intramedullary nails, screws, and accessory components) for surgical fusion. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies section also indicates that non-clinical and clinical testing were not necessary, which is typical for predicate-based submissions of mechanical devices and not for devices incorporating complex software or AI/ML.
No.
The device is described as an intramedullary nail system intended for arthrodesis (fusion) and stabilization of the hindfoot and ankle, which are structural and mechanical functions, not therapeutic in the sense of treating a disease or condition through non-invasive means or by directly restoring function without structural alteration.
No
This device is a surgical implant designed for tibiotalocalcaneal arthrodesis (fusion) and stabilization of the hindfoot and ankle, as described in the "Intended Use / Indications for Use" and "Device Description" sections. It is used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is comprised of intramedullary nails, screws, and accessory components, which are physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Phantom® Hindfoot TTC/TC Nail system is comprised of intramedullary nails, screws, and accessory components. These are physical implants used within the body for surgical procedures.
- Intended Use: The intended use is for tibiotalocalcaneal arthrodesis (fusion) and stabilization of the hindfoot and ankle. This is a surgical procedure performed directly on the patient's anatomy.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Phantom® Hindfoot TTC/TC Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- · Post-traumatic or degenerative arthritis
- · Previously infected arthrosis
- Revision of failed ankle arthrodesis
- · Revision of failed total ankle arthroplasty
- · Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
- · Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
- Rheumatoid arthritis
- · Osteoarthritis
- Nonunions or pseudarthrosis of hindfoot and distal tibia
- · Trauma (severe or malunited tibial pilon fracture)
- · Charcot foot (neuroarthropathy)
- · Severe end-stage degenerative arthritis
- Instability and skeletal defects after tumor resection
- · Pantalar arthrodesis
- · Severe foot/ankle deformity
Product codes
HSB, HWC
Device Description
The Paragon 28® Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes, lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 testing was not necessary to support equivalence. Engineering analyses were provided to support equivalence. Clinical testing was not necessary to support equivalence.
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
§ 888.3020 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
July 17, 2020
Paragon 28, Inc. Samuel Pollard Associate Director, Regulatory Affairs MCRA, LLC 1050 K St NW Suite 1000 Washington, District of Columbia 20001
Re: K201227
Trade/Device Name: Phantom® Hindfoot TTC/TC Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB. HWC Dated: June 18, 2020 Received: June 18, 2020
Dear Samuel Pollard:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/trainingand-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DVCE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Phantom® Hindfoot TTC/TC Nail System
Indications for Use (Describe)
The Phantom® Hindfoot TTC/TC Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- · Post-traumatic or degenerative arthritis
- · Previously infected arthrosis
- Revision of failed ankle arthrodesis
- · Revision of failed total ankle arthroplasty
- · Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
- · Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
- Rheumatoid arthritis
- · Osteoarthritis
- Nonunions or pseudarthrosis of hindfoot and distal tibia
- · Trauma (severe or malunited tibial pilon fracture)
- · Charcot foot (neuroarthropathy)
- · Severe end-stage degenerative arthritis
- Instability and skeletal defects after tumor resection
- · Pantalar arthrodesis
- · Severe foot/ankle deformity
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) |
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510(K) SUMMARY
| Device Trade Name: | Phantom® Hindfoot TTC/TC Nail System |
|---|---|
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Ms. Haylie Hertz |
| Regulatory Affairs Specialist | |
| Phone: 720.758.9058 | |
| hhertz@paragon28.com | |
| Prepared by: | Mr. Samuel Pollard |
| Associate Director, Regulatory Affairs | |
| MCRA, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20005 | |
| Phone: 202.552.5800 | |
| spollard@mcra.com | |
| 510(k) Number: | K201227 |
| Date Prepared: | June 18, 2020 |
| Classification: | 21 CFR §888.3020, Intramedullary Nail, Bone Screw |
| 21 CFR §888.3040, Screw, fixation, bone | |
| Class: | II |
| Product Code: | HSB, HWC |
| Common Name: | Intramedullary Nail |
| Predicate Device: | TTC Phantom® Intramedullary Nail System (Primary: K192163 |
| Additional: K191782) | |
| Indications for Use: | The Phantom® Hindfoot TTC/TC Nail System is intended for |
| tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of | |
| the hindfoot and ankle including the transverse tarsal joints coupling | |
| the mid-foot to the hindfoot. Examples of specific indications | |
| include: | |
| • Post-traumatic or degenerative arthritis | |
| • Previously infected arthrosis |
- Revision of failed ankle arthrodesis .
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- Revision of failed total ankle arthroplasty
- Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
- Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
- Rheumatoid arthritis ●
- Osteoarthritis ●
- Nonunions or pseudarthrosis of hindfoot and distal tibia
- Trauma (severe or malunited tibial pilon fracture) ●
- Charcot foot (neuroarthropathy)
- Severe end-stage degenerative arthritis
- Instability and skeletal defects after tumor resection ●
- Pantalar arthrodesis ●
- Severe foot/ankle deformity ●
Device Description: The Paragon 28® Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes, lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.
Substantial Equivalence:
The intended use of the modified devices, as described in its labeling, has not changed as a result of the modifications proposed in the present submission. In addition, the subject device possesses the same technological characteristics as the predicate device, including performance, basic design, material, manufacturing, and sizes. Differences between the Phantom® nails and the predicate devices (i.e. modified internal thread, chamfers, and manufacturing features) were shown not to raise new questions of safety and effectiveness. Therefore, the Phantom® Hindfoot TTC/TC Nail System is substantially equivalent to the predicate device cited on the previous page with respect to indications, design, function, and performance.
Non-Clinical Testing:
Non-clinical testing was not necessary to support equivalence. Engineering analyses were provided to support equivalence.
Clinical Testing:
Clinical testing was not necessary to support equivalence.
Conclusion:
The Phantom® ActivCore Nail possesses the same intended use and technological characteristics as the predicate devices. Therefore, the Phantom® ActivCore Nail is substantially equivalent for its intended use.