Atlas FDA

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

Orthofix Srl — Predicate Candidate Screening

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

119 daysmedian FDA review time
245 days90th percentile
38clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl2026-05-191190
K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening SyOrthofix Srl2026-05-081470
K250112FitboneTM TrochantericOrthofix Srl2025-04-10840
K242270OrthoNext Platform SystemOrthofix Srl2024-12-191400
K242861TrueLok ElevateOrthofix Srl2024-12-03740
K233867Fitbone TrochantericOrthofix Srl2024-06-181951
K232648RODEO Telescopic NailOrthofix Srl2024-05-032460
K232169FITBONE® Transport and Lengthening SystemOrthofix Srl2024-03-222450
K213572JuniOrtho Plating System™Orthofix Srl2022-01-18690
K212044TrueLok EvoOrthofix Srl2021-11-051280
K210157SOLE Medial Column Fusion PlateOrthofix Srl2021-04-20890
K202519OrthoNext Platform SystemOrthofix Srl2020-10-27560
K200246JPS JuniOrtho Plating SystemOrthofix Srl2020-05-221120
K190388RIVAL View Plating Systems and Reduce Fracture Plating SysteOrthofix Srl2019-06-071080
K180624Guided Growth Plate System PlusOrthofix Srl2018-05-15670
K172699Agile NailOrthofix Srl2018-04-232280
K172698G-Beam Fusion Beaming SystemOrthofix Srl2018-02-071530
K172183Guided Growth Plate System PlusOrthofix Srl2018-01-091740
K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric NailingOrthofix Srl2017-12-07300
K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILOrthofix Srl2017-11-16490
K170146Galaxy UNYCO SystemOrthofix Srl2017-10-122680
K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017-05-10680
K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric NailingOrthofix Srl2017-01-242420
K153233Galaxy UNYCO SystemOrthofix Srl2016-01-06580
K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl2015-09-28550
K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl2014-12-10400
K141760ORTHOFIX GALAXY WRISTOrthofix Srl2014-12-081600
K142052ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KITOrthofix Srl2014-12-051300
K141571ORTHOFIX ANKLE HINDFOOT NAILING SYSTEMOrthofix Srl2014-11-121530
K141078ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)Orthofix Srl2014-09-021300
K122541ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)Orthofix Srl2012-09-20300
K113770ORTHOFIX GALAXY FIXATION SYSTEMOrthofix Srl2012-09-042574
K062920ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSPOrthofix Srl2006-11-13460
K053261ORTHOFIX TITANIUM NAILING SYSTEMSOrthofix Srl2005-12-12200
K051945MIOT PLATING SYSTEMOrthofix Srl2005-09-06500
K974186ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COrthofix Srl1998-03-181310
K973944ORTHOFIX FEMORAL NAILING SYTEMOrthofix Srl1997-12-19640
K944092ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEMOrthofix Srl1995-04-042250

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