510(k) Report

FDA applicant

Praxim Medivision, SA

La Tronche, FR2 decisions2007–20102 recalls

FDA records 2 decisions for Praxim Medivision, SA (La Tronche, FR) from 2007 to 2010: 2 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and HAW (Neurological Stereotaxic Instrument). Its devices cite 4 predicates, 0 of them its own earlier devices. 2 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 Praxim Medivision, SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2019

2016: 12019: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • OLOOrthopedic Stereotaxic Instrument1decision
  • HAWNeurological Stereotaxic Instrument1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 20102cite it
  • K063408Ctlogics Navigations SystemsPraxim Medivision, SA · 20072cite it

What has FDA decided for it lately?

  • K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 20102 recalls
  • K063408Ctlogics Navigations SystemsPraxim Medivision, SA · 2007

All 2 as Praxim Medivision, SA →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K090953OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock…Apr 12, 2019Class II
  • K090953OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with…Oct 14, 2016Class III

Other applicant names beginning “Praxim”

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

Praxim S.A 4Praxim 4