Summary
The selected FDA evidence documents AxiaLIF Plus clearance K102334 (March 14, 2011) and Trans1 Facet Screw clearance K073515 (March 11, 2008). Device records link a Vectre-branded facet screw to K073515. Original applicant and legacy labeler names are preserved; these are not new approvals issued to today’s TranS1 LLC. [11][10][1]
AxiaLIF+ requires supplemental fixation. The website-linked AxiaLIF IFU is revision G dated January 21, 2019 and contains model/level-specific language; the current product page emphasizes L5–S1. Current single- and two-level availability and the latest labeling must be confirmed rather than inferred from historical family clearances. [3][8][5]
The published AxiaLIF labeling identifies bowel injury and associated infection among procedural risks and specifies patient-selection restrictions. Vectre labeling describes facet screws used with anterior fusion products and bone graft. Marketing statements about superior safety, fusion rates, navigation or recovery are not treated as independently established comparative outcomes. [8][9]
Selected AxiaLIF and Vectre name-based FDA recall searches did not establish matching recall records. The review remains partial, and PMA and De Novo searches were not completed. A clearance, procedure code or manufacturer statement does not itself establish payer coverage. [12]
