# Orthosoft, Inc.

- Location (FDA's records): Montreal, CA
- FDA decisions: 14 (1998–2013): 14 510(k) clearances
- Product codes: HAW (12), OLO (1), JWH (1)
- Predicates its devices cite: 21 (13 its own); citations of its devices by later devices: 34 (13 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Brainlab AG: 2 (https://510kreport.com/company/brainlab)
- Materialise NV: 2 (https://510kreport.com/company/materialise)
- Compass Intl., Inc.: 1 (https://510kreport.com/company/compass-intl)
- Carl Zeiss, Inc.: 1 (https://510kreport.com/company/carl-zeiss)
- Praxim S.A: 1 (https://510kreport.com/company/praxim-s-a)
- Kinamed, Inc.: 1 (https://510kreport.com/company/kinamed)

## Firms that cite its devices most
- Mako Surgical Corp.: 4 (https://510kreport.com/company/mako-surgical)
- Orthalign, Inc.: 4 (https://510kreport.com/company/orthalign)
- Intellijoint Surgical, Inc.: 2 (https://510kreport.com/company/intellijoint-surgical)
- Mazor Surgical Technologies, Ltd.: 2 (https://510kreport.com/company/mazor-surgical-technologies)
- Plus Orthopedics: 2 (https://510kreport.com/company/plus-orthopedics)
- Blue Belt Technologies, Inc.: 1 (https://510kreport.com/company/blue-belt-technologies)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Jointpoint, Inc.: 1 (https://510kreport.com/company/jointpoint)

## Its most-cited devices
- K043536: Navitrack System - S&N Image Free Knee (2005), cited by 5
- K022364: Navitrack System Total Hip Replacement,Model 900.200 (2003), cited by 5
- K041369: Navitrack System - S&N Image Free Hip, Model Pro-03017 (2004), cited by 4
- K021760: Navitrack System-Optical TKR CT-Less, Model 900.120 (2002), cited by 4
- K002053: Navitrak System-Optical Option, Model 900.004 (2000), cited by 3
- K060336: Navitrack System-OS Knee Universal, Model Pro-05002 (2006), cited by 3

## Recent decisions
- K131409: Cas Psi Knee System (Sep 13, 2013)
- K100599: Cas 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 MM (Apr 5, 2010)
- K071929: Navitrack System- Partial Hip Resurfacing Universal (Sep 19, 2007)
- K071714: Navitrack System - OS Unicondylar Knee Universal, Model#  Pro-06003 (Jul 20, 2007)
- K060336: Navitrack System-OS Knee Universal, Model Pro-05002 (Apr 28, 2006)
- K043536: Navitrack System - S&N Image Free Knee (Jan 14, 2005)
- K041369: Navitrack System - S&N Image Free Hip, Model Pro-03017 (Jun 22, 2004)
- K032917: Navitrack System - Total Hip Replacement CT-Free (Oct 21, 2003)

Source page: https://510kreport.com/company/orthosoft