DynaNail® TTC Fusion System - Instructions For Use | MedShape DynaNail® TTC Fusion System - Instructions For Us | Page 3

1. DEVICE DESCRIPTION
The DynaNail® TTC Fusion System consists of the following components: the
DynaNail TTC Fusion Nail, DynaNail End Cap, DynaNail Screws, and the DynaNail
Deployment Frame.
The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are
implanted into the medullary canal of the @bia, talus and calcaneus using the
DynaNail Deployment Frame and Ancillary Surgical Instruments.
The DynaNail TTC Fusion Nail is manufactured from ni@nol and @tanium alloy (Ti
6Al-4V ELI) and is available in mul@ple diameters and lengths. The DynaNail End
Cap is manufactured from @tanium alloy (Ti-6AI-4V ELI). The DynaNail Screws are
manufactured from @tanium alloy (Ti 6Al-4V ELI) and are available in a range of
lengths.
The Ancillary Surgical Instruments are specifically designed for use with the
DynaNail TTC Fusion System. These specialized instruments are required to correctly
perform the DynaNail implanta@on procedure and to remove the DynaNail TTC
Fusion Nail and DynaNail Screws if required, following implanta@on.
2. INDICATIONS FOR USE
The DynaNail TTC Fusion System is intended for use in @biotalocalcaneal
arthrodesis and the treatment of trauma to the hindfoot and distal @bia.
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Post-trauma@c and degenera@ve arthri@s.
Post-trauma@c or primary arthrosis involving both ankle and subtalar joints.
Revision aTer failed ankle arthrodesis with subtalar involvement.
Failed total ankle arthroplasty.
Nonunion ankle arthrodesis.
Rheumatoid hindfoot.
Absent talus (requiring @biocalcaneal arthrodesis).
Avascular necrosis of the talus.
Neuroarthropathy or neuropathic ankle deformity.
Neuromuscular disease and severe deformity.
Osteoarthri@s.
Charcot foot.
Previously infected arthrosis, second degree.
3. CONTRAINDICATIONS
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Pa@ents with an ac@ve local or systemic infec@on.
Pa@ents with an ac@ve soT @ssue infec@on or osteomyeli@s of foot and ankle.
Pa@ents with severe peripheral vascular disease.
Pa@ents with an obliterated medullary canal or other condi@ons that tend
to retard healing such as blood supply limita@ons or previous infec@ons.
Pa@ents with an insufficient plantar pad.
Skeletally immature pa@ents where the implant would cross
open epiphyseal plates.
Pa@ents having an intact asymptoma@c subtalar joint.