# K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Jan 14, 2019 after 143 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K954385 (1996). 284 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 293 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170693: Phantom Small Bone Intramedullary Nail System, Paragon 28, Inc. (2017) Summary page 6.
- K171376: DynaNail TTC Fusion System, MedShape, Inc. (2017) Summary page 6.
- K120419: Dyna Locking Ankle Nail, U&I Corp. (2012) Summary page 7.
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System, CarboFix Orthopedics, Ltd. (2013) Summary page 7.
- K130147: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail), Small Bone Innovations, Inc. (2013) Summary page 7.

## Most influential descendants
- K192163: TTC Phantom® Intramedullary Nail System (2020), 6 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own
- K201227: Phantom® Hindfoot TTC/TC Nail System (2020), 5 descendants of its own
- K210869: Phantom Hindfoot TTC/TC Nail System (2021), 2 descendants of its own
- K251850: Phantom® Hindfoot TTC/TC Nail System (2025), 1 descendant of its own

## 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. 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

Source page: https://510kreport.com/device/K182307
Methodology: https://510kreport.com/methodology