Class Class II
SMR Shoulder System (K223876)
Description
SMR Shoulder System by Lima Corporate S.P.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223876
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeMBF
Regulation Number888.3670
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223876
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. SMR Shoulder System (K223876) cites 6 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | 2022 |
| K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021 |
| K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017 |
| K133349 | SMR TT METAL BACK GLENOID | Lima Corporate S.P.A. | 2014 |
| K113254 | SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SM... | Lima Corporate S.P.A. | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025 |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023 |
Trace the full predicate network for K223876
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.