Cleared Traditional

K061362 - PIGALILEO TOTAL KNEE REPLACEMENT (TKR) ...

K061362 is an FDA 510(k) clearance for PIGALILEO TOTAL KNEE REPLACEMENT (TKR) ..., manufactured by Plus Orthopedics AG. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K061362 · Plus Orthopedics AG · Neurology device
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Oct 2006
Decision
143d
Days
Class 2
Risk

K061362 is an FDA 510(k) clearance for the PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Plus Orthopedics AG (Norfolk, US). The FDA issued a Cleared decision on October 6, 2006 after a review of 143 days - within the typical 510(k) review window.

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

View all Plus Orthopedics AG devices

FDA 510(k) Submission Details - K061362

510(k) Number K061362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2006
Decision Date October 06, 2006
Days to Decision 143 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 148d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

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 242
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