Cleared Traditional

K122011 - NAVIGATION SOFTWARE HIP-UNIVERSAL

Also marketed or referenced as:
NAVIGATION SOFTWARE HIP THR-AESCULAP

K122011 is an FDA 510(k) clearance for NAVIGATION SOFTWARE HIP-UNIVERSAL, 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 129-day FDA review.

K122011 · Brainlab AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
129d
Days
Class 2
Risk

K122011 is an FDA 510(k) clearance for the NAVIGATION SOFTWARE HIP-UNIVERSAL. 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 November 15, 2012 after a review of 129 days - within the typical 510(k) review window.

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 - K122011

510(k) Number K122011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2012
Decision Date November 15, 2012
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 433
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K122011.
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
K122742 · Nuvasive, Inc. · Dec 2012
NAVIOPFS
K121936 · Blue Belt Technologies, Inc. · Nov 2012
SMARTTOOLS KNEE SYSTEM
K122326 · Zimmer · Nov 2012
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
K120867 · Medos International SARL · Sep 2012
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
K121064 · Mako Surgical Corporation · Jun 2012
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
K112507 · Mako Surgical Corporation · Mar 2012