Class Class II
SMR Reverse HP Shoulder System (K243826)
Description
SMR Reverse HP Shoulder System by Lima Corporate S.P.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243826
Clearance Date2025-07-03
Clearance TypeTraditional
Product CodePHX
Regulation Number888.3660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243826
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 Reverse HP Shoulder System (K243826) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 |
| K142139 | SMR 40MM GLENOSPHERE | Lima Corporate S.P.A. | 2014 |
| K112898 | DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS | Lima Corporate S.P.A. | 2012 |
| K110598 | SMR REVERSE SHOULDER SYSTEM | Lima Corporate S.P.A. | 2011 |
| K100858 | LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR ... | Lima-Lto S.P.A. | 2010 |
Trace the full predicate network for K243826
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.