Class Class II
U-Motion II Acetabular System-Extension line (K221149)
Description
U-Motion II Acetabular System-Extension line by United Orthopedic Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221149
Clearance Date2023-01-05
Clearance TypeTraditional
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221149
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. U-Motion II Acetabular System-Extension line (K221149) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corporation | 2018 |
| K170089 | U-Motion II Acetabular System- Additional sizes | United Orthopedic Corporation | 2017 |
| K132455 | U-MOTION II PS+ CUP | United Orthopedic Corp. | 2013 |
| K122185 | U-MOTION II ACETABULAR SYSTEM | United Orthopedic Corp. | 2013 |
| K111546 | U2 HIP SYSTEM | United Orthopedic Corp. | 2011 |
Trace the full predicate network for K221149
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.