Xtant Medical

Summary

FDA records document Class II 510(k) clearances for the selected spinal fixation, interbody and DBM families. Spider is linked to X-Spine Systems clearances K052292 (2005) and K170224 (2017). Acquired families retain predecessor applicants, including Pioneer/RTI and Surgalign; these names do not represent separate current companies on this profile. ^{[7][17][24][20][21]}

FDA lists open Class II recalls affecting specified Cortera screws, CervAlign plates, Irix-A implants and Xpress screws. A separate 2026 nanOss 3D / 3D Plus shelf-life labeling recall is retained in the safety review without assigning it to the current Strata formulation. These are product- and lot-specific records; they do not establish a recall of the entire portfolio or any Republic Medical inventory. ^{[130][46][132][134][136]}

The regulatory snapshot covers selected current families and is a documented minimum. The exact clearance for current nanOss Strata remains unresolved. Tissue products and third-party products distributed by Xtant have distinct regulatory pathways and are not assigned blanket device clearance; divested Coflex/CoFix and international hardware assets are excluded. ^{[1][139][146]}