Orthofix

Summary

Orthofix’s spine and orthopedic portfolio combines 510(k)-cleared families with original PMA lineages including CervicalStim (P030034), AccelStim (P210035), and PhysioStim/SpinalStim (P850007, counted once). SeaSpine and 7D histories retain the original applicants. The discontinued M6-C disc is excluded from current commercial counts while its authorization and recall history remain visible. The FDA decision/recall searches are completed for the named company and acquired applicants. Exact current-family assignment of some legacy/supplier records remains unestablished; those records are excluded from the snapshot. ^{[298][297][295][483][479][481][456][469][4]}

The matched FDA history contains 52 distinct recall events: 18 open, 34 terminated. 18 were initiated during the five years beginning October 20, 2021; older open events are also retained. Z-3226-2026 (2026-08-19; open, classified): The proximal thread depth of the spinal device is out of design specification. Z-2820-2026 (2026-07-02; open, classified): Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm… Z-2729-2026 (2026-06-10; open, classified): Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 ^{[393][392][388][389][390][391]}