K Number
K182307
Device Name
Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System
Manufacturer
Date Cleared
2019-01-14

(143 days)

Product Code
Regulation Number
888.3020
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Small Bone Phantom® Intramedullary Nail System is indication and fixation and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, pseudarthroses and malunions by revision. joint fusion or reconstruction procedures. 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
Device Description
The Paragon 28® Small Bone Phantom® Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Small Bone Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Small Bone Phantom® 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. 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
More Information

Not Found

No
The device description and performance studies focus on the mechanical properties and design of intramedullary nails, screws, and pegs for bone fixation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.

Yes
The device is intended for the treatment of various medical conditions, including fractures, osteotomies, and arthrodesis, and provides stabilization for bones, which aligns with the definition of a therapeutic device.

No

The device is an intramedullary nail system used for fixation and fusion of bones in the feet and ankle, not for diagnosing conditions.

No

The device description explicitly states it is comprised of physical components like intramedullary nails, locking screws, threaded pegs, and instruments for implantation. There is no mention of software as the primary or sole component.

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, or tissue) to provide information about a person's health.
  • Device Description and Intended Use: The provided text clearly describes the device as an intramedullary nail system used for surgical fixation and fusion of bones in the feet and ankle. This is an implantable surgical device, not a device that performs tests on bodily samples.
  • Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological markers, or any other activity associated with in vitro diagnostics.

Therefore, based on the provided information, the Small Bone Phantom® and TTC Phantom® Intramedullary Nail Systems are surgical implants, not IVDs.

N/A

Intended Use / Indications for Use

Small Bone Phantom® Intramedullary Nail System:
The Small Bone Phantom® Intramedullary Nail System is indication and fixation and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, pseudarthroses and malunions by revision. joint fusion or reconstruction procedures.

TTC Phantom® Intramedullary Nail System:
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 (comma separated list FDA assigned to the subject device)

HSB, KTW, HWC

Device Description

Small Bone Phantom® Intramedullary Nail System:
The Paragon 28® Small Bone Phantom® Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Small Bone Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Small Bone Phantom® 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.

TTC Phantom® Intramedullary Nail System:
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

feet and ankle; hindfoot and ankle

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)

Small Bone Phantom® Intramedullary Nail System:
Engineering analysis is presented to provide evidence that the subsequent performance of the Small Bone Phantom® Intramedullary Nail System is not adversely affected by the design modifications.
The results of the analysis demonstrated the subject devices are substantially equivalent to the Phantom™ Small Bone Intramedullary Nail predicate

TTC Phantom® Intramedullary Nail System:
All necessary testing has been performed on representative TTC Phantom® Intramedullary Nail System components. The device performance was characterized via four-point bend testing per ASTM F1264. Clinical data are not needed to support the safety and effectiveness of the subject devices. Engineering analysis is presented to assure substantial equivalence of the TTC Phantom® Intramedullary Nail System to its predicates. The results of the analysis demonstrated the subject devices are substantially equivalent to the Dyna Locking Ankle NailTM and Piccolo Composite® Nailing System predicates.

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.

Small Bone Phantom® Intramedullary Nail System:
K170693

TTC Phantom® Intramedullary Nail System:
K171376, K120419, K123810, K130147

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

§ 888.3020 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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 14, 2019

Paragon 28, Inc. Mr. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E., Ste 280 Englewood, Colorado 80112

Re: K182307

Trade/Device Name: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullarv Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB. KTW. HWC Dated: December 20, 2018 Received: December 31, 2018

Dear Mr. 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

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Peter G. Allen Digitally signed by Peter
G. Allen -s Date: 2019.01.14 13:28:37 -5 -05'00'

FOR 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) K182307

Device Name

Small Bone Phantom® Intramedullary Nail System

Indications for Use (Describe)

The Small Bone Phantom® Intramedulary Nail System is indication and fixation and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, pseudarthroses and malunions by revision. joint fusion or reconstruction procedures.

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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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known)

K182307

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Date:October 3rd, 2018
Sponsor:Paragon 28, Inc.
4B Inverness Ct. E., STE 280
Englewood, Colorado 80112
Phone: (888) 728-1888
Fax: (888) 728-1220
Sponsor contact:Eric Lintula, Director of Regulatory Affairs
Trade Names:Small Bone Phantom® Intramedullary Nail System
TTC Phantom® Intramedullary Nail System
Small Bone Phantom®
Regulatory Class:Class II
TTC Phantom®
Regulatory Class:Class II
Small Bone Phantom®
Regulation, Product
Code, Classification,
and Common Name:888.3030, KTW, Appliance, fixation, nail/blade/plate
combination, single component
888.3040, HWC, Smooth or threaded metallic bone fixation
fastener, bone screw
TTC Phantom®
Regulation, Product
Code, Classification,
and Common Name:888.3020, HSB, Rod, Fixation, Intramedullary And
Accessories
888.3040, HWC, Smooth or threaded metallic bone fixation
fastener, bone screw
Small Bone Phantom®
Device Description:The Paragon 28® Small Bone Phantom® Intramedullary Nail
System is comprised of small bone intramedullary nails,
locking screws and threaded pegs. The Small Bone
Phantom® nails are offered in a variety of lengths to
accommodate variations in patient anatomy. The Small Bone
Phantom® 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.
TTC Phantom®
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
Small Bone Phantom®
Materials:The Small Bone 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.
TTC Phantom®
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.
Small Bone Phantom®
Indications for Use:The Small Bone Phantom® 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.
TTC Phantom®
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
Small Bone Phantom®
Primary Predicate:K170693, Phantom™ Small Bone Intramedullary Nail
System
TTC Phantom®
Primary Predicate:K171376, DynaNail™ Ankle Arthrodesis Nail
TTC PhantomⓇ
Additional Predicates:K120419, Dyna Locking Ankle Nail™
K123810, Piccolo CompositeⓇ Nailing System – Ankle Arthrodesis
K130147, SBi Anatomic Ankle Arthrodesis Interlocking Nail System
Small Bone PhantomⓇ
Comparison to
Predicate Indications:The subject Small Bone PhantomⓇ Intramedullary Nail System is a modification of the unmodified Phantom™ Small Bone Intramedullary Nail System, and therefore has the same indications.
TTC PhantomⓇ
Comparison to
Predicate Indications:The subject TTC PhantomⓇ Intramedullary Nail System and predicate DynaNail™ Ankle Arthrodesis Nail, Dyna Locking Ankle Nail™, Piccolo CompositeⓇ Nailing System for Ankle Arthrodesis, and SBi Anatomic Ankle Arthrodesis Interlocking Nail System devices are intended to be used for tibiotalocalcaneal arthrodesis. All devices are indicated for use in the hindfoot and ankle. All indications for the subject device are within the indications of the predicate devices.
Small Bone PhantomⓇ
Comparison to
Predicate
Technological
Characteristics:The subject Small Bone PhantomⓇ intramedullary nail and components possess the same technological characteristics as the predicate device. 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 subject Small Bone PhantomⓇ intramedullary nail and components is similar to the previously cleared device.
TTC PhantomⓇ
Comparison to
Predicate
Technological
Characteristics:The subject TTC PhantomⓇ intramedullary nail and components 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 subject TTC PhantomⓇ intramedullary nail and components is similar to previously cleared devices.
Small Bone PhantomⓇ
Performance Data:Engineering analysis is presented to provide evidence that the subsequent performance of the Small Bone PhantomⓇ Intramedullary Nail System is not adversely affected by the design modifications.
The results of the analysis demonstrated the subject devices are substantially equivalent to the Phantom™ Small Bone Intramedullary Nail predicate
TTC Phantom®
Performance Data:All necessary testing has been performed on representative
TTC Phantom® Intramedullary Nail System components.
The device performance was characterized via four-point
bend testing per ASTM F1264. Clinical data are not needed
to support the safety and effectiveness of the subject devices.
Engineering analysis is presented to assure substantial
equivalence of the TTC Phantom® Intramedullary Nail
System to its predicates.
The results of the analysis demonstrated the subject devices
are substantially equivalent to the Dyna Locking Ankle
NailTM and Piccolo Composite® Nailing System predicates.
Conclusion:Engineering analysis demonstrates the substantial
equivalence of the Small Bone Phantom® Intramedullary
Nail System to the PhantomTM Small Bone Intramedullary
System and the TTC Phantom® Intramedullary Nail System
to the Dyna Locking Ankle NailTM and Piccolo Composite®
Nailing System. Therefore, the Phantom® Intramedullary
Nail Systems are substantially equivalent to the predicate
devices with respect to their indications for use, technical
characteristics, and function.

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