U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (K243656)
Description
U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella by United Orthopedic Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243656
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+ Patella; USTAR II System– PF+ Patella (K243656) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221705 | U2 Total Knee System-PF+ | United Orthopedic Corporation | 2023 |
| K212941 | Porous Patella | Encore Medical, L.P. Dba Djo Surgical | 2022 |
| K190100 | USTAR II System | United Orthopedic Corporation | 2019 |
| K132624 | TRIATHLON TRITANIUM METAL-BACKED PATELLA | Stryker Orthopaedics | 2013 |
Trace the full predicate network for K243656
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.