Class Class II
OvertureTi Knee Resurfacing SystemTM (K242746)
Description
OvertureTi Knee Resurfacing SystemTM by Overture Orthopaedics, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242746
Clearance Date2024-10-07
Clearance TypeSpecial
Product CodeHSX
Regulation Number888.3520
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242746
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. OvertureTi Knee Resurfacing SystemTM (K242746) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | 2023 |
Trace the full predicate network for K242746
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.