1. Data on File. PRECICE STRYDE Max Patient Weight Assessment. Report LR0838-1
2. Landge V, Shabtai L, Gesheff M, et al. Patient satisfaction after limb lengthening with internal and external devices. J of Surg Orthop Advanc 2015;24(3):174-9.
3. Laubscher M, Mitchell C, Timms A, et al. Outcomes following femoral lengthening. An initial comparison of the Precice intramedullary lengthening nail and the LRS external fixator monorail system. Bone Joint J 2016;98-B:1382-8.
The PRECICE System is composed of an implantable intramedullary nail, locking screws, reusable instruments, and a hand-held External Remote Controller (ERC). The STRYDE nail is a sterile single use device that is
surgically implanted using the instruments and locking screws. The ERC
is used daily after implantation to non-invasively lengthen or shorten the
implant to a prescribed length. The PRECICE STRYDE System is intended for
limb lengthening of the femur and tibia. Contraindications include infection
or pathologic conditions of bone such as osteopenia which would impair the
ability to securely fix the device, metal allergies and sensitivities, patients
whose distance from the surface of the treated limb to the intramedullary
canal is greater than 80mm for the 13.0mm diameter implant, 65 mm for
the 11.5 mm implant and 50mm for the 10.0mm diameter implant, patients
with an irregular bone diameter that would prevent insertion of the STRYDE
nail, patients in which the STRYDE nail would cross joint spaces or open
epiphyseal growth plates, patients in which there are conditions that tend to
retard healing such as blood supply limitations, peripheral vascular disease
or evidence of inadequate vascularity, patients unwilling or incapable of
following postoperative care instructions, 150lbs for the 10.0mm diameter
implant, 200lbs for the 11.5mm diameter implant and 250lbs for the 13.0
mm implant. The implantable device is only to be used by a trained licensed
physician. Please refer to the PRECICE STRYDE System instructions for use
for complete Important Safety Information.