# K210869: Phantom Hindfoot TTC/TC Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Jun 28, 2021 after 97 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K954385 (1996). 293 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 296 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201227: Phantom® Hindfoot TTC/TC Nail System, Paragon 28, Inc. (2020) Summary page 4.

## Most influential descendants
- K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (2023), 1 descendant of its own
- K241262: Baby Gorilla/Gorilla Plating System; Monster Screw System (2024), 0 descendants of its own

## Recalls of this device
- Dec 21, 2023 · Class II · Z-1256-2024: Medical devices distributed, prior to sterilization
- Dec 21, 2023 · Class II · Z-1255-2024: Medical devices distributed, prior to sterilization
- Dec 21, 2023 · Class II · Z-1254-2024: Medical devices distributed, prior to sterilization

## 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

Source page: https://510kreport.com/device/K210869
Methodology: https://510kreport.com/methodology