Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Orthohelix Surgical Designs, Inc. · Predicate Candidate Screening

25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

62 daysmedian FDA review time
125 days90th percentile
25clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142148ORTHOHELIX STAPLE SYSTEMOrthohelix Surgical Designs, Inc.2014-08-21160
K141004INTRAOSSEOUS FIXATION SYSTEMOrthohelix Surgical Designs, Inc.2014-08-211250
K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMOrthohelix Surgical Designs, Inc.2014-07-11530
K132733ORTHOHELIX SYNDESMOSIS FIXATION DEVICESOrthohelix Surgical Designs, Inc.2014-01-031220
K132591MAXLOCK EXTREME SYSTEMOrthohelix Surgical Designs, Inc.2013-09-17290
K130832ORTHOHELIX STAPLE SYSTEMOrthohelix Surgical Designs, Inc.2013-08-151420
K131324MAXTORQUE SCREW SYSTEMOrthohelix Surgical Designs, Inc.2013-05-31230
K123203MAXLOCK EXTREME SYSTEM MODEL MXLOrthohelix Surgical Designs, Inc.2012-12-14630
K122005MAXLOCK EXTREME SYSTEMOrthohelix Surgical Designs, Inc.2012-09-06590
K121437MINI MAXLOCK EXTREME PLATING SYSTEMOrthohelix Surgical Designs, Inc.2012-06-13290
K120165INTRAOSSEOUS FIXATION SYSTEMOrthohelix Surgical Designs, Inc.2012-04-17890
K120157MINI MAXLOCK EXTREME PLATING SYSTEMOrthohelix Surgical Designs, Inc.2012-04-10830
K113048MAXLOCK EXTREME SYSTEMOrthohelix Surgical Designs, Inc.2012-01-301100
K111041MINI VARIABLE SYSTEMOrthohelix Surgical Designs, Inc.2011-06-06530
K102156MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATEOrthohelix Surgical Designs, Inc.2010-09-30621
K101962MINI MAXLOCK EXTREME PLATING SYSTEMOrthohelix Surgical Designs, Inc.2010-09-27761
K100618MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLEOrthohelix Surgical Designs, Inc.2010-04-20470
K093900EDGELOCKOrthohelix Surgical Designs, Inc.2010-02-17610
K090289CLAVICLE PLATING SYSTEMOrthohelix Surgical Designs, Inc.2009-06-151300
K082574MAXTORQUE MINI CANNULATED SCREW SYSTEMOrthohelix Surgical Designs, Inc.2008-12-08943
K073624MODULAR FOOT SYSTEMOrthohelix Surgical Designs, Inc.2008-03-20851
K061400CALCANEAL TRAUMA SYSTEMOrthohelix Surgical Designs, Inc.2006-06-29410
K060428CSS CANNULATED SCREW SYSTEMOrthohelix Surgical Designs, Inc.2006-03-07144
K053182DRLOCK DISTAL RADIUS VOLAR SYSTEMOrthohelix Surgical Designs, Inc.2006-02-271052
K050868MAXLOCKOrthohelix Surgical Designs, Inc.2005-05-27510

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda