Providing Solutions in Orthopedics…..

A: Nail features – All in one Solutions

The SorathFibula Plating System provides fixation during fractures, fusions, and osteotomies for the tibia and fibula, with Lateral Fibula, Winged Distal FibulaPlate and Lateral distal tibia Hook Plate options.
The system was designed to be low profile and includes locking screws and anodized finish to the plates, and is a modular component of the Lower Extremity Modular System, housing a range of implants and instrumentation for foot and ankle indications.

• Multiple interlock options for optimal purchase in tibial fractures with short proximal or short distal fragments.
• Proximal Interlock Options
◦ Two medio-lateral (ML) locking options - One in static mode and one Dynamic locking option
◦ Two oblique hole options, increase the stability of the proximal fragment.
• Distal interlock Options
◦ Two medio-lateral (ML) locking options, the most distal interlock option is within the most distal 1cm of the nail
◦ One Antero-Posterior option
• End cap prevents in-growth of tissue and facilitates easier nail extraction
◦ 0 mm end cap sits flush with nail
◦ 5 mm, 10 mm and 15 mm end caps extend nail height if indicated.
• Anatomic bend in nail for easy insertion
• Cannulated nails 8 mm to 11 mm for reamed or unreamed techniques, enabling nail insertion over guide wire.

B: Indications

The Hyper Tibial Nail is indicated for

• Tibia shaft fractures
• Proximal Tibia fractures [41-A2/A3]
• Distal Tibia fractures [43-A1/A2/A3]
• Segmental comminuted fractures of tibia and Combinations of these fractures in the same tibia.
• In certain fractures of articular injuries with metaphyseal comminution or with extension to diaphysis (41-C, 43-C), the Hyper Tibial Nail may be used in combination with other fixation modalities to suitably stabilise the reduced articular surface injury. The emphasis in these articular injuries is restoration of articular surface, and the nail then addresses the need for intramedullary stabilisation of the metaphyseal / diaphyseal injury, as planned by the surgeon.
• Impending pathologic fractures of shaft tibia.
• Use of a cannulated Hyper Tibial Nail with a large diameter offering more stability associated with the reamed technique is generally recommended for pseudarthroses, mal-unions and non-unions.

C: Safety & Electromagnetic Compatibility

Please click here to read the instructions concerning the above mentioned Trauma Implants made by SORATH Surgical. This document contains safety instructions and electromagnetic compatibility (EMC) information for the implants.

D: Conformation & Regulatory Clearance

Please click here for the Certificate of license to manufacture for sale of SORATH Implants

E: Metallurgy

Various Metallurgy tests like In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity Study, Acute Systemic Toxicity Study & Intramuscular Implantation (4 week) have been undertaken to meet the required standards.

Implant materials offered by SORATH:-
• Stainless Steel (SS316L)
• Stainless Steel (SS316LVM)
• Titanium (G5)
• Titanium (G4)
• Titanium (23)