Class Class II
U2 Total Knee System-PF+ (K221705)
Description
U2 Total Knee System-PF+ by United Orthopedic Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221705
Clearance Date2023-02-28
Clearance TypeTraditional
Product CodeMBH
Regulation Number888.3565
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221705
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. U2 Total Knee System-PF+ (K221705) cites 7 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181794 | Truliant Porous Femoral Components | Exactech, Inc. | 2018 |
| K150829 | U2 Total Knee System- Additional Sizes | United Orthopedic Corporation | 2015 |
| K150832 | U2 Femoral Component, CR, Porous Coated, Additional Sizes | United Orthopedic Corporation | 2015 |
| K140075 | U2 FEMORAL COMPONENT, CR, POROUS COATED | United Orthopedic Corp. | 2014 |
| K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE | Stryker | 2013 |
| K120507 | UNITED U2 FEMORAL COMPONENT, PS, #7 | United Orthopedic Corporation | 2012 |
| K051640 | U2 TOTAL KNEE SYSTEM | United Orthopedic Corp. | 2006 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Pa... | United Orthopedic Corporation | 2025 |
Trace the full predicate network for K221705
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.