Cleared Traditional

K190633 - NanoOrtho NanoKnee® System

K190633 is an FDA 510(k) clearance for NanoOrtho NanoKnee System, manufactured by Nanoortho, LLC. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 283-day FDA review.

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

FDA 510(k) Submission Details - K190633

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.

HRY Device Classification - Class 2, Special Controls

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 82
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
MPO Total Knee Systems MR Labeling
K152631 · Microport Orthopedics, Inc. · Mar 2016
RESTORIS POROUS PARTIAL KNEE SYSTEM
K150410 · Mako Surgical Corporation · Mar 2015
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
K133940 · Biomet UK, Ltd. · Mar 2014
UNIVATION
K131167 · Aesculap Implant Systems, LLC · Oct 2013
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
K122277 · Biomet Manufacturing Corp · Oct 2012