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

Orthosoft, Inc. — Predicate Candidate Screening

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

68 daysmedian FDA review time
121 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K131409CAS PSI KNEE SYSTEMOrthosoft, Inc.2013-09-131211
K100599CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DOrthosoft, Inc.2010-04-05330
K071929NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSALOrthosoft, Inc.2007-09-19682
K071714NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PROOrthosoft, Inc.2007-07-20282
K060336NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002Orthosoft, Inc.2006-04-28773
K043536NAVITRACK SYSTEM - S&N IMAGE FREE KNEEOrthosoft, Inc.2005-01-14230
K041369NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017Orthosoft, Inc.2004-06-22291
K032917NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREEOrthosoft, Inc.2003-10-21290
K030827NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 9Orthosoft, Inc.2003-05-23701
K031156NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005Orthosoft, Inc.2003-05-09280
K022364NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200Orthosoft, Inc.2003-02-041970
K021760NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120Orthosoft, Inc.2002-08-27900
K002053NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004Orthosoft, Inc.2000-08-03280
K981315NAVITRACKOrthosoft, Inc.1998-07-09900

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