# K253591: Phantom® Hindfoot TTC/TC Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Mar 5, 2026 after 108 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: 18 generations back to K954385 (1996). 294 ancestors in all.
No later device cites it as a predicate yet.
0 of 295 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251850: Phantom® Hindfoot TTC/TC Nail System, Paragon 28, Inc. (2025) Summary page 5.

## Indications for use
The Phantom® Hindfoot TTC/TC Nail System is indicated 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/K253591
Methodology: https://510kreport.com/methodology