Class Class II
Uni Knee Resurfacing System (K221292)
Description
Uni Knee Resurfacing System by Overture Resurfacing, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221292
Clearance Date2023-03-10
Clearance TypeTraditional
Product CodeHSX
Regulation Number888.3520
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221292
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. Uni Knee Resurfacing System (K221292) cites 1 predicate device and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K050373 | UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS | Arthrosurface, Inc. | 2005 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242307 | ACHIEVE Partial Knee System | Ignite Orthomotion | 2024 |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | 2024 |
| K231253 | Overture Orthopaedics Patellofemoral System | Overture Resurfacing, Inc. | 2023 |
Trace the full predicate network for K221292
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.