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The Speed Triad is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The Speed Triad is a nitinol implant that comes in a range of sizes for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis of the hand and foot. The implant is delivered to the operating room in an "open" state in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient temperature and body heat after insertion, and contracts to a "closed" and compressive state. The implants do not require any external heating; they are completely transformed at room temperature. The Speed Triad incorporates design changes from the Speed Shift. The design is changed to include a third leg to provide additional fixation. Importantly, the Speed Triad uses the same raw material as the predicate Speed Shift and the same manufacturing process (heat treatment, surface treatment, and passivation).

Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The Speed XLTM is for use in fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The implant is designed so that it is delivered to the operating room in an "open" martensitic state. The implant is then transformed by room temperature after insertion, and contracts to a "closed" austenitic state. The implant does not require any external heating; it is completely transformed by room temperature. This configuration change for the Speed XL™ consists of a change in device shape, including flattened bridge with wider dimension to be used in hand and foot procedures.

The HammerLock® is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

The Hammerlock is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The Hammerlock device is situated in the intramedullary space and the prongs extending into the cancellous bone. When the device is warmed by body temperature. the prongs deflect outward to create an anchoring force. This configuration change for the Hammerlock involves minor configuration changes and adding new sizes to the product line for surgeon choice to better conform to patient anatomy.

The OSStaple™ Chill is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and, Fixation of proximal tibial metaphysis osteotomy.

The OSStaple M Chill is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is. then transformed by body heat after insertion, and contracts to a "closed" austenitic state. The OSStaple TM Chill differs from the OSStaple TM in that the staples:do not require any external heating; they are completely transformed by body heat. The OSStaple! 100 Chill also includes staples with smooth and barbed legs to achieve increased pull-out resistance: All other characteristics of the implant are identical to the OSStapleTM predicate.

The HammerLock™ is indicated for small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

The HammerLock™ is an addition to the OSSPlate™ line and is designed for use as an intramedullary bone fixation device. The OSSPlate™ is situated on the bone with the prongs extending through the cortex and in its final configuration the prongs are deflected inward to create a clamping force. With the HammerLock™ the device is situated in the intramedullary space with the prongs extending into the cancellous bone and in the final configuration the prongs are deflected outward to create a compressive force. Two models of the HammerLock™ are provided for physician choice, the HammerLock™ X-Type and HammerLock™ Loop. Both exhibit similar test results to the predicate devices. The HammerLock™ models transformed to their final configuration by body heat alone.

The BioWarm" is indicated for use as an ancillary device for the OSStaple" staple system.

The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm" gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm electrode and will cease if the button is released prior to the automatic cessation by the circuitry

The Memograph® Staple is intended for: l ) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.

The Memograph® Staple system consists of two and four prong staples for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) fixation of soft tissue to bone such as in anterior crucate ligament reconstruction. The staple is fabricated from Nitinol. The staple's prongs are parallel during insertion. Application of an electrical current from the Warmsystem to the staple causes its prong to deflect inward. This inward deflection causes staple retention and compression across the osteotomy or arthrodesis site.