(66 days)
No
The description focuses on the mechanical components of an intramedullary nail system for arthrodesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for "tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle," which are treatments for various medical conditions, indicating a therapeutic purpose.
No
The device is an intramedullary nail system intended for arthrodesis (fusion) and stabilization of the hindfoot and ankle, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is comprised of intramedullary nails, screws, and accessory components, which are physical hardware implants.
No, 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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the TTC Phantom® Intramedullary Nail system is comprised of physical implants (nails, screws) intended for surgical implantation to fuse bones in the hindfoot and ankle. This is a surgical device used in vivo (within the body), not in vitro (in a lab).
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, laboratory procedures, or diagnostic information derived from such analysis.
Therefore, based on the provided information, the TTC Phantom® Intramedullary Nail system is a surgical implant, not an In Vitro Diagnostic device.
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 TTC Phantom® nails are offered in a variety of sizes and lengths to accommodate variations in patient anatomy. The TTC 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, ankle, transverse tarsal joints, mid-foot, distal tibia
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
Engineering analysis and a cadaveric implantation study are presented to provide evidence that the original testing and subsequent performance is not adversely affected by the geometry of the modified devices.
The results of the analysis and study demonstrate the modified designs are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
September 6, 2019
Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E., STE 280 Englewood, Colorado 80112
Re: K191782
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: August 15, 2019 Received: August 15, 2019
Dear Eric Lintula:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,
For Michael C. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191782
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
| 510(k) Number: | K191782 |
|---|---|
| Date: | July 1st, 2019 |
| Sponsor: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, Colorado 80112 | |
| Phone: (855) 786-2828 | |
| Fax: (888) 728-1220 | |
| Sponsor contact: | Eric Lintula, Director of Regulatory Affairs |
| Trade Name: | TTC Phantom® Intramedullary Nail System |
| Regulatory Class: | Class II |
| Regulation, | |
| Product Code, | |
| Classification, and | |
| Common Name: | 888.3020, HSB, Rod, Fixation, Intramedullary And Accessories |
| 888.3040, HWC, Screw, Fixation, Bone | |
| Device | |
| Description: | The Paragon 28® TTC Phantom® Intramedullary Nail System |
| is comprised of intramedullary nails, screws and accessory | |
| components. The TTC Phantom® nails are offered in a variety | |
| of sizes and lengths to accommodate variations in patient | |
| anatomy. The TTC Phantom® screws insert through the | |
| intramedullary nail to secure the construct. These are offered in | |
| varying lengths to accommodate the anatomical fixation | |
| required. | |
| Materials: | The TTC Phantom® Intramedullary Nail System implants are |
| made from Titanium Alloy (ASTM F136). The instrumentation | |
| is manufactured from medical grades of titanium alloy, stainless | |
| steel, anodized aluminum and polymer. | |
| 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 | |
| Charcot foot (neuroarthropathy) Severe end-stage degenerative arthritis Instability and skeletal defects after tumor resection Pantalar arthrodesis Severe foot/ankle deformity | |
| Primary | |
| Predicate: | K182307, TTC Phantom® Intramedullary Nail System |
| K102413, Vilex FUZE TTC Arthrodesis Compression Nail | |
| K040212, Smith & Nephew TRIGEN INTERTAN | |
| Reference Devices: | Intertrochanteric Antegrde Nails |
| K190365, Paragon 28 Baby Gorilla®/Gorilla® Plating System | |
| K120419, Lavender Medical Dyna Locking Ankle (DLA) Nail | |
| Performance | |
| Data: | Engineering analysis and a cadaveric implantation study are |
| presented to provide evidence that the original testing and | |
| subsequent performance is not adversely affected by the | |
| geometry of the modified devices. | |
| The results of the analysis and study demonstrate the modified | |
| designs are substantially equivalent to the predicate devices. | |
| Technological | |
| Characteristics: | The modified devices possess the same technological |
| characteristics as the predicate devices. These include; | |
| Performance, Basic design, Material, Manufacturing, and Sizes (dimensions are comparable to those offered by the | |
| predicate systems). Therefore, the fundamental scientific technology of the modified | |
| devices is similar to the previously cleared devices. | |
| Conclusion: | The modified TTC Phantom® Intramedullary Nail System |
| possesses the same indications for use and technological | |
| characteristics as the predicate device. Therefore, the modified | |
| devices are substantially equivalent to the predicate. |
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