Cleared Traditional

NanoOrtho NanoKnee® System (K190633) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190633 · Nanoortho, LLC · Orthopedic device
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Dec 2019
Decision
283d
Days
Class 2
Risk

K190633 is an FDA 510(k) clearance for the NanoOrtho NanoKnee® System. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Nanoortho, LLC (Arroyo Grande, US). The FDA issued a Cleared decision on December 20, 2019 after a review of 283 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 Nanoortho, LLC devices

Submission Details

510(k) Number K190633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2019
Decision Date December 20, 2019
Days to Decision 283 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
161d slower than avg
Panel avg: 122d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 90
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K190633.
SIGMA High Performance (HP) Partial Knee System
K193549 · Depuy Ireland UC · Apr 2020
EVOLUTION UNICONDYLAR KNEE SYSTEM
K100973 · Wrightmedicaltechnologyinc · Aug 2010
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
K082567 · Howmedica Osteonics Corp. · Oct 2008
TRIATHLON PKR SYSTEM
K071881 · Howmedica Osteonics Corp. · Oct 2007
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · Biomet, Inc. · Nov 2004
REPICCI LOCKED KEEL TIBIAL BEARING
K030446 · Biomet, Inc. · Mar 2003