Skip to content

Total Knee Surgetics Navigation System with Iblock

by Praxim Medivision, SA

510(k) K090953

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK090953 Date21 Jan 2010ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1717-2019 FDA Class II initiated 12 Apr 2019

    The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.

    • Terminated Z-0610-2017 FDA Class III initiated 14 Oct 2016

    Incorrect lot number on outer kit

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Praxim Medivision, SA