# K190633: NanoOrtho NanoKnee® System

- Pathway: 510(k) (Traditional)
- Applicant: Nanoortho, LLC
- Decided: Dec 20, 2019 after 283 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943462 (1994). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073175: Journey Unicondylar Femoral Implant, Smith & Nephew, Inc. (2007) Summary page 4.
- K133811: Restoris Porous Partial Knee System, Mako Surgical Corp. (2014) Summary page 4.

## Indications for 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.

Source page: https://510kreport.com/device/K190633
Methodology: https://510kreport.com/methodology