Pediatric Plating Platform I Small-Mini

The Pediatric Plating Platform | Small-Mini is a bone fixation system consisting of plates and screws in various sizes and shapes for internal fracture fixation, osteotomies, malunions, and non-unions of the appendicular skeleton. It is intended for children (2-12 years), adolescents (12-21 years) with fused growth plates or unfused plates that won't be compromised, and adults. When used in major load-bearing bones (femur, tibia, humerus, patella, pelvis), it is limited to non-load bearing stabilization and reduction.

The device includes straight and shaped plates in multiple configurations (Reconstruction, Strength, T-Plate, L-Plate, Y-Plate, Triangle, Distal Radius, Mesh, Tubular, Locking Compression, Hook plates) with polyaxially locking and non-locking screws in 2.0, 2.4, 2.7, and 3.5 families. It is manufactured from implant-grade 316LVM stainless steel (ASTM F138/F139). A key difference from predicates is the inclusion of a mesh plate design not present in the predicate devices, though similar mesh plates have been previously cleared.

ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119 (MR environment evaluation); ASTM F543 (axial pullout strength); ASTM F382 (static compression bending); additional testing for torsional properties, insertion and removal torque.