# K221221: Advanced Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Dec 21, 2022 after 238 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: 5 generations back to K960642 (1996). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143276: Acumed Small Bone IM Nail System, Acumed, LLC (2015) Summary page 4.
- K043052: Trigen Hindfoot Fusion Nail, Smith & Nephew, Inc. (2004) Summary page 4.

## Indications for use
Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment, stabilization, fixation of fractures caused by trauma or diseases. Indications: 1.Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna. 2.Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula. 3.Ankle Fusion Nail: Indicated for degeneration,deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion;failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.

Source page: https://510kreport.com/device/K221221
Methodology: https://510kreport.com/methodology