Cleared Special

K090953 - TOTAL KNEE SURGETICS NAVIGATION SYSTEM ...

K090953 is the FDA 510(k) clearance for TOTAL KNEE SURGETICS NAVIGATION SYSTEM ... by Praxim Medivision, SA. It is a Class 2 Orthopedic device (product code OLO) cleared through the Special 510(k) pathway after a 293-day FDA review.

K090953 · Praxim Medivision, SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
293d
Days
Class 2
Risk

K090953 is an FDA 510(k) clearance for the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Praxim Medivision, SA (La Tronche, FR). The FDA issued a Cleared decision on January 21, 2010 after a review of 293 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Praxim Medivision, SA devices

Submission Details

510(k) Number K090953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2009
Decision Date January 21, 2010
Days to Decision 293 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 122d · This submission: 293d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 355
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K090953.
ORTHOMAP 3D 1.1 MODULE
K093206 · Stryker Corp. · Aug 2010
BRAINLAB KNEE ARTHROSCOPY
K093118 · Brainlab AG · Jun 2010
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · Smith & Nephew, Inc. · Feb 2010
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
K092497 · Smith & Nephew, Inc. · Sep 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
K090420 · Smith & Nephew, Inc. · May 2009
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
K083483 · Brainlab AG · Apr 2009