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K Number
K192163
Device Name
TTC Phantom® Intramedullary Nail System
Manufacturer
Paragon 28, Inc.
Date Cleared
2020-01-31

(175 days)

Product Code
HSB,HWC
Regulation Number
888.3020
Type
Traditional
Panel
OR
Reference & Predicate Devices
K182307,K171376,K120419
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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
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.

AI/ML Overview

This document describes a 510(k) premarket notification for the TTC Phantom® Intramedullary Nail System, which is a medical device for tibiotalocalcaneal arthrodesis. It does NOT describe an AI/ML powered device, and therefore the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, sample sizes for training/test sets, expert involvement, and reader studies is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to predicate devices through:

  1. Indications for Use: Listing the specific conditions for which the device is intended.
  2. Device Description: Detailing the components of the system.
  3. Preclinical Testing: Describing mechanical testing (static and dynamic per ASTM F1264-14), wear testing, and biocompatibility evaluation (per ISO 10993-1 and CDRH's 2016 Biocompatibility Guidance). Additional testing mentioned includes bacterial endotoxins and sterilization.
  4. Conclusion: Stating that the device is substantially equivalent to predicates based on intended use, technological characteristics, and preclinical testing.

Therefore, I cannot provide details on AI/ML acceptance criteria or studies from the provided text.

§ 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.