External Fixation Bone Distractor

The External Fixation Bone Distractor is a transverse bone transport system designed to assist in controlled movement of a bone segment across a defect. It is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities in adult and pediatric patients (greater than 2 through 21 years of age). The device can be used independently or in conjunction with other external fixation systems to form hybrid frames.

The device features serrated connection bolts to prevent rotational movement and loosening, customizable frame configurations, an 11mm diameter rod with 100mm length, a distractor with 17mm travel length, and half pins in 3, 4, and 5mm diameters with blunt tips and lengths from 150–200mm. Materials include stainless steel (ASTM F138/AISI 316LVM) for pins and various stainless steel grades, aluminum alloy (EN-AW 6082 T6), and polyphenylsulfone polymer for frame components.

ASTM F1541-17 was used to evaluate mechanical performance of worst-case component configurations under design control procedures. No additional bench testing was performed; instead, existing data from mechanically demanding components within the device system were analyzed.

The subject device shares the same intended use as the predicate (TrueLok Elevate, K242861)—facilitating gradual distraction of a tibial bone segment for extremity conditions. Both incorporate serrated bolts, support customizable frames, and use identical half-pin materials (ASTM F138/AISI 316LVM). Minor dimensional differences (17mm vs. 14mm travel length, different pin diameters/lengths) do not raise different safety or effectiveness questions because the subject device's pins and clamping methods match those of Reference Device B (K242452), a cleared predicate device, and the core mechanical function remains equivalent.