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MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.

The MODUS IMF Screws 2.0 are provided in two screw types with different plateau geometries and various lengths. Both designs are self-drilling with cross heads and include holes for insertion of a wire parallel to the cross head as well as grooves for the attachment of elastic bands.

The APTUS® Titanium Fixation System is intended for use in hand and forearm fractures, osteotomies and arthrodeses. APTUS® Hand group: - Management of the fractures of the distal, middle and proximal phalanges . and metacarpals - Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures - DIP and PIP arthrodoses t APTUS® Radius 2.5 group: - Management via radio volar approach of extra-articular extension and . flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures - Management via dorsal approach of rare extension fractures that cannot be . adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

The APTUS® Titanium Fixation System consists of implant plates and implant screws and is used for internal fixation of small bones. APTUS Plates Implant Modules are provided in sizes Hand 1.2, Hand 1.5, Hand 2.0, Hand 2.3 for miplant Modules are pro rised in oristius reconstruction plate system is used for fixation valious iniger segmonts. The distal for corrective osteotomies of the distal radius with of fractures or the under laccess. Variations of plate shapes include H frame, straight, T and L shaped. APTUS Screws Locking screws for the Radius and Hand 2.0 Lock product lines, designated TriLock™, utilize a spherical three point wedge locking design and are used with locking plates. Conventional bone screws have a double thread design and precisely cut sharp thread profile, tapering core diameter and atraumatic tip. The shorter screws have a small pitch in order to maintain optimal purchase in the bone, while the longer screws have a larger pitch in order to minimize the number of revolutions.

The Modus® Modular Distraction Osteogenesis System is a subcutaneous distractor system intended for use in fractures, osteotomies and arthrodeses including: treatment of hemifacial microsomia, mandibular hypoplasia, microglossia, defects of the alveolar ridge, atrophic bone segments in the mandible and maxilla, mandibular symphysis widening, growth disturbances of the ascending corpus/ascending ramus, and LeFort I, and LeFort II/III advancements.

The Modus plates are used with the Modus Distraction Cylinders for various applications of the maxillofacial bone structures. The Modus plates are offered in a variety of sizes and are designed to fit the anatomy of the mandible and/or maxilla and allow adjustment of the vector by intra-operative bending if indicated. The Modus Distraction Cylinders are used with the Modus plates and screws for gradual bone distraction osteogenesis and for corrective osteotomies of the mandible and maxilla. The Modus distraction cylinders are available in uni-directional or bi-directional with multiple distraction lengths. Flexible extensions are to be used with distraction cylinders if needed. The extensions allow additional access for distraction of the surgical site. The implant plates and ARS distractors are made of CP titanium Grade 4 and comply with ASTM F 67 standards for unalloyed titanium for surgical implant applications. The MDO distraction cylinders and flexible extensions are made of implant steel that complies with ASTM F 138 or ASTM F 139.

The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.

The MODUS® Titanium Osteosynthesis System consists of implant plates, implant screws and instruments and is used for the internal fixation of fractures, correction osteotomies, the bridging of load bearing bone segments and distraction in the craniofacial skeleton. This submission includes modifications to the MODUS system plates that enhance clinical effectiveness due to improved strength or anatomical adaptation. All modifications discussed in this submission use previously cleared Medartis titanium screws.