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510(k) Data Aggregation
K Number
K190633Device Name
NanoOrtho NanoKnee® System
Manufacturer
NanoOrtho, LLC
Date Cleared
2019-12-20
(283 days)
Product Code
HRY, HSX, NJD
Regulation Number
888.3530Why did this record match?
Applicant Name (Manufacturer) :
NanoOrtho, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NanoOrtho NanoKnee® System is indicated for restoring either compartment of a knee that has been affected by the following:
1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Correction of femoral deformity;
3. Revision procedures where other treatments or devices have failed; and
4. Treatment of fractures that are unmanageable using other techniques.
The NanoOrtho NanoKnee® System components are single use and are intended for implantation with or without bone cement.
Device Description
The NanoOrtho NanoKne® is a unicompartmental knee system that includes porous coated and non-porous coated, cast CoCr, symmetric femoral components in sizes 1-6; and Ti6Al4V, symmetric, porous coated and non-porous coated tibial baseplate components in sizes 1-6. The tibial inserts are offered in standard UHMWPE, symmetric design, Constrained+, in sizes 1-6 and 5 thicknesses per size 9,10,11,12,14mm.
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