Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 09x09x07mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 09mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow)

Awl

Forceps

Insertion Adaptor, Extended, Sz. 8mm

Insertion Adaptor, Extended, Sz. 10mm

Insertion Adaptor, Extended, Sz. 12mm

Insertion Adaptor, Extended, Sz. 14mm

Insertion Adaptor, Extended, Sz. 16mm

Speed Adapter Hex, Open Sz. 8mm

Speed Adapter Hex, Open Sz. 10mm

Speed Adapter Hex, Open Sz. 12mm

Speed Adapter Hex, Open Sz. 14mm

Speed Adapter Hex, Open Sz. 16mm

Hex Adapter Housing Assembly

Hex Adapter Housing Assembly

Hex Adapter Housing Assembly

Hex L-Key

Pathfinder

Starter Rasp

Adapter, Hex, Manual Ratchet Driver Assembly

Mini Wing Reset

Ratchet Wrench with lock sleeve, Manual

Mini Pathfinder

Minuteman Insertion Instrument

Insertion Adaptor, Extended, Sz. 8/10/12 MM

Insertion Adaptor, Extended, Sz. 14/16 MM

BioSphere Flex SP Extremities, Small

BioSphere Flex SP Extremities, Medium

BioSphere Flex, Medium

BioSphere Flex, Large