Cleared Traditional

K093118 - BRAINLAB KNEE ARTHROSCOPY

K093118 is an FDA 510(k) clearance for BRAINLAB KNEE ARTHROSCOPY, manufactured by Brainlab AG. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K093118 · Brainlab AG · Orthopedic device
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Jun 2010
Decision
252d
Days
Class 2
Risk

K093118 is an FDA 510(k) clearance for the BRAINLAB KNEE ARTHROSCOPY. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on June 11, 2010 after a review of 252 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainlab AG devices

FDA 510(k) Submission Details - K093118

510(k) Number K093118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2009
Decision Date June 11, 2010
Days to Decision 252 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 122d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

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 370
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K093118.
BRAINLAB KNEE
K102990 · Brainlab AG · Apr 2011
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
K103400 · Stryker Corporation · Mar 2011
ORTHOMAP 3D 1.1 MODULE
K093206 · Stryker Corp. · Aug 2010
MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
K093425 · Mako Surgical Corp. · Feb 2010
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · Smith & Nephew, Inc. · Feb 2010
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
K091998 · Mako Surgical Corp. · Sep 2009