(175 days)
No
The document describes a mechanical intramedullary nail system and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical and biocompatibility testing.
Yes
The device is described as an "Intramedullary Nail System" intended for "tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle," which directly addresses and treats various medical conditions and deformities. These functions align with the definition of a therapeutic device.
No
The device is an intramedullary nail system intended for surgical fusion and stabilization of the hindfoot and ankle, which are therapeutic actions, not diagnostic ones.
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:
- Intended Use: The intended use is for surgical procedures (arthrodesis and stabilization) of the hindfoot and ankle. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is comprised of physical implants (intramedullary nails, screws, and accessory components) designed to be surgically inserted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
The TTC Phantom® Intramedullary 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® TTC Phantom® Intramedullary 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)
Static and dynamic mechanical testing per ASTM F1264-14 and wear testing after dynamic compression was conducted on the TTC Phantom® Intramedullary Nail System. Biocompatibility was evaluated per ISO 10993-1 and CDRH's 2016 Biocompatibility Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Additional testing includes bacterial endotoxins and sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Paragon 28 TTC Phantom® Intramedullary Nail System (K182307), MedShape, Inc. DynaNail TTC Fusion System (K171376), Lavender Medical Limited (formerly U&I Corporation) Dyna Locking Ankle Nail (K120419)
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
January 31, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
Paragon 28, Inc. Ms. Haylie Hertz Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112
Re: K192163
Trade/Device Name: TTC Phantom® Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: January 8, 2020 Received: January 8, 2020
Dear Ms. Haylie Hertz:
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 identifies combination 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 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
1
801); medical device 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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, PhD, RAC Acting Assistant Director Knee Arthroplasty Devices Team DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K192163
Device Name
TTC Phantom® Intramedullary Nail System
Indications for Use (Describe)
The TTC Phantom® Intramedullary 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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3
510(K) SUMMARY
| Device Trade Name: | TTC Phantom® Intramedullary Nail System |
|---|---|
| 510(k) Number: | K192163 |
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Ms. Haylie Hertz |
| Regulatory Affairs Specialist | |
| Phone: 720-758-9058 | |
| Email: hhertz@paragon28.com | |
| Prepared by: | Mr. Samuel Pollard |
| Associate Director, Regulatory Affairs | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NE, Suite 1000 | |
| Washington, DC 20005 | |
| Phone: 202.552.5800 | |
| spollard@mcra.com | |
| Date Prepared: | January 30, 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 Devices: | Primary Predicate: Paragon 28 TTC Phantom® Intramedullary |
| Nail System (K182307) | |
| Additional Predicates: MedShape, Inc. DynaNail TTC Fusion | |
| System (K171376), Lavender Medical Limited (formerly U&I | |
| Corporation) Dyna Locking Ankle Nail (K120419) | |
| Indications for Use: | The TTC Phantom® Intramedullary Nail System is intended for |
| tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of | |
| the hindfoot and ankle including the transverse tarsal joints coupling |
4
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 o 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) o
- Severe end-stage degenerative arthritis ●
- Instability and skeletal defects after tumor resection
- Pantalar arthrodesis ●
- Severe foot/ankle deformity o
The Paragon 28® TTC Phantom® Intramedullary Nail System is Device Description: 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 TTC Phantom® Intramedullary Nail System is substantially equivalent to the predicate devices cited above with respect to indications, design, function, and performance.
Preclinical Testing:
Static and dynamic mechanical testing per ASTM F1264-14 and wear testing after dynamic compression was conducted on the TTC Phantom® Intramedullary Nail System. Biocompatibility was evaluated per ISO 10993-1 and CDRH's 2016 Biocompatibility Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Additional testing includes bacterial endotoxins and sterilization.
Conclusion:
The TTC Phantom® Intramedullary Nail System has the same intended use and equivalent technological characteristics as the predicate devices. Additionally, the preclinical testing supports the substantial equivalence of the TTC Phantom® Intramedullary Nail System to the predicates. Therefore, the TTC Phantom® Intramedullary Nail System is substantially equivalent for its intended use.