Cleared Traditional

K060121 - BIOMET PRE-CALIBRATED COMPUTER AIDED SU...

K060121 is the FDA 510(k) clearance for BIOMET PRE-CALIBRATED COMPUTER AIDED SU... by Biomet Manufacturing Corp. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K060121 · Biomet Manufacturing Corp · Neurology device
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Mar 2006
Decision
63d
Days
Class 2
Risk

K060121 is an FDA 510(k) clearance for the BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP A.... Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on March 21, 2006 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Biomet Manufacturing Corp devices

Submission Details

510(k) Number K060121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2006
Decision Date March 21, 2006
Days to Decision 63 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 148d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 217
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