510(k) Report

FDA applicant

Orthosoft, Inc.

Montreal, CA14 decisions1998–20139 recalls

FDA records 14 decisions for Orthosoft, Inc. (Montreal, CA) from 1998 to 2013: 14 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and OLO (Orthopedic Stereotaxic Instrument). Its devices cite 21 predicates, 13 of them its own earlier devices. 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Orthosoft, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 22010: 12013: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007: 12008: 42009: 22014: 1
2007high 4 (2008) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Orthosoft, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orthosoft, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument12decisions
  • OLOOrthopedic Stereotaxic Instrument1decision
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1decision

Whose devices does it build on?

Its devices cite 21 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 13 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K043536Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 20055cite it
  • K022364Navitrack System Total Hip Replacement,Model 900.200Orthosoft, Inc. · 20035cite it
  • K041369Navitrack System - S&N Image Free Hip, Model Pro-03017Orthosoft, Inc. · 20044cite it
  • K021760Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 20024cite it
  • K002053Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 20003cite it
  • K060336Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc. · 20063cite it

What has FDA decided for it lately?

  • K131409Cas Psi Knee SystemOrthosoft, Inc. · 20131 recall
  • K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton Pin 3.2 Dia X 150 MMOrthosoft, Inc. · 2010
  • K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc. · 20073 recalls
  • K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 20072 recalls
  • K060336Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc. · 20063 recalls
  • K043536Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
  • K041369Navitrack System - S&N Image Free Hip, Model Pro-03017Orthosoft, Inc. · 20041 recall
  • K032917Navitrack System - Total Hip Replacement CT-FreeOrthosoft, Inc. · 2003

All 14 as Orthosoft, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K131409PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented…Nov 3, 2014Class II
  • K060336Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF…Nov 2, 2009
  • K071929NDI P7 Position Sensor, Stereotaxic InstrumentJun 9, 2009Class II
  • K060336Navitrack System - OS Knee Universal, Stereotaxic instrumentOct 28, 2008Class II
  • K071714Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for…Aug 19, 2008
  • K060336Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic InstrumentJun 20, 2008Class III

Other applicant names beginning “Orthosoft”

FDA records each applicant name separately; these may or may not be the same firm.

Orthosoft Inc (D/B/A Zimmer Cas) 27