# K123810: Piccolo Composite Ankle Arthrodesis Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Jun 14, 2013 after 185 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: 12 generations back to K841189 (1984). 87 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102369: Piccolo Composite Nailing System, N.M.B. Medical Applications, Ltd. (2011) Summary page 1.
- K111056: Piccolo Composite Nailing System, CarboFix Orthopedics, Ltd. (2011) Summary page 1.
- K081243: Biomet Phoenix Ankle Nail System, Biomet Trauma (2008) Summary page 2.
- K091976: Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail, Biomet Trauma (2009) Summary page 2.
- K090857: Valor Ankle Fusion Nail System, Wrightmedicaltechnologyinc (2009)

## Most influential descendants
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own
- 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
- K132774: Piccolo Composite Nailing System (2013), 3 descendants of its own

## Indications for use
The Piccolo Composite Ankle Arthrodesis Nails are indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: Avascular necrosis of the talus Failed total ankle arthroplasty Trauma (malunited tibial pilon fracture) Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease Revision ankle arthrodesis Neuroarthropathy Rheumatoid arthritis Osteoarthritis Pseudoarthrosis Post-traumatic arthrosis Previously infected arthrosis Charcot foot Severe endstage degenerative arthritis Severe defects after tumor resection Pantalar arthrodesis

Source page: https://510kreport.com/device/K123810
Methodology: https://510kreport.com/methodology