AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (K251184)
Description
AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System by Encore Medical, L.P., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251184
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. AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (K251184) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233481 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2024 |
| K142139 | SMR 40MM GLENOSPHERE | Lima Corporate S.P.A. | 2014 |
| K141006 | RSP HUMERAL SOCKET INSERT | Djo Global | 2014 |
| K110598 | SMR REVERSE SHOULDER SYSTEM | Lima Corporate S.P.A. | 2011 |
| K051075 | ENCORE REVERSE SHOULDER PROSTHESIS | Encore Medical L.P. | 2005 |
Trace the full predicate network for K251184
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.