Class Class II
Medline UNITE® Ankle Fusion Plating System (K222665)
Description
Medline UNITE® Ankle Fusion Plating System by Medline Industries, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222665
Clearance Date2023-01-25
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222665
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. Medline UNITE® Ankle Fusion Plating System (K222665) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213567 | Medline UNITE Calcaneal Fracture Plating System | Medline Industries, LP | 2022 |
| K151235 | Medline Foot Plates and Screws | Medline Industries, Inc. | 2015 |
| K140397 | PARALOCK PLATING SYSTEM / TUFFNEK SCREW | Paragon 28 | 2014 |
| K121425 | ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM | Wrightmedicaltechnologyinc | 2012 |
Trace the full predicate network for K222665
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.