Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lima Corporate S.P.A. — Predicate Candidate Screening
64 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
284 days90th percentile
64clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral Sys | Lima Corporate S.P.A. | 2026-01-22 | 177 | 0 |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | 2025-08-29 | 86 | 0 |
| K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025-07-03 | 203 | 0 |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025-05-22 | 52 | 0 |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024-12-18 | 26 | 0 |
| K234011 | AMF TT Cones | Lima Corporate S.P.A. | 2024-01-18 | 30 | 0 |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024-01-11 | 52 | 0 |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023-12-21 | 247 | 0 |
| K231925 | MINIMA S System | Lima Corporate S.P.A. | 2023-07-11 | 11 | 0 |
| K221758 | SMR Stemless Anatomic | Lima Corporate S.P.A. | 2023-03-17 | 274 | 0 |
| K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023-02-03 | 42 | 0 |
| K222405 | Smart SPACE Shoulder Planner and 3D Positioners | Lima Corporate S.P.A. | 2022-12-20 | 133 | 0 |
| K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | 2022-10-26 | 40 | 1 |
| K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022-10-06 | 56 | 3 |
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022-05-19 | 62 | 0 |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | 2022-02-25 | 176 | 2 |
| K213381 | Physica system | Lima Corporate S.P.A. | 2021-12-17 | 65 | 1 |
| K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021-07-12 | 124 | 0 |
| K210554 | Physica system | Lima Corporate S.P.A. | 2021-04-06 | 40 | 0 |
| K203475 | LimaCorporate Kirschner Wire | Lima Corporate S.P.A. | 2021-02-05 | 72 | 0 |
| K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | 2020-12-17 | 161 | 0 |
| K201084 | Physica system | Lima Corporate S.P.A. | 2020-12-14 | 235 | 0 |
| K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2020-11-19 | 301 | 0 |
| K200656 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | 2020-07-08 | 118 | 0 |
| K200653 | AMF Revision TT Cones | Lima Corporate S.P.A. | 2020-05-07 | 56 | 0 |
| K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020-01-31 | 65 | 0 |
| K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2019-11-22 | 144 | 0 |
| K191622 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | 2019-11-01 | 136 | 0 |
| K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | 2019-10-10 | 79 | 0 |
| K181491 | Delta Dual Mobility System | Lima Corporate S.P.A. | 2019-05-09 | 337 | 0 |
| K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019-02-16 | 269 | 1 |
| K183042 | SMR Lateralized Connectors with screws | Lima Corporate S.P.A. | 2019-01-25 | 84 | 0 |
| K182099 | Delta TT Pro | Lima Corporate S.P.A. | 2018-12-26 | 145 | 0 |
| K172456 | Bone Screws 6.5mm | Lima Corporate S.P.A. | 2018-01-04 | 143 | 0 |
| K170473 | C2 femoral stem | Lima Corporate S.P.A. | 2017-11-08 | 265 | 0 |
| K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017-06-29 | 206 | 1 |
| K161120 | SMR TT Metal Back Glenoid, Bone Graft instruments | Lima Corporate S.P.A. | 2017-02-21 | 306 | 0 |
| K161226 | Revision Femoral Stem | Lima Corporate S.P.A. | 2017-02-10 | 284 | 0 |
| K160011 | H-Max S stem | Lima Corporate S.P.A. | 2016-08-22 | 231 | 0 |
| K161476 | SMR Shoulder System | Lima Corporate S.P.A. | 2016-06-24 | 28 | 0 |
| K153722 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2016-04-06 | 100 | 0 |
| K151739 | Revision Femoral Stem | Lima Corporate S.P.A. | 2015-11-23 | 150 | 0 |
| K152008 | Physica PS Knee System | Lima Corporate S.P.A. | 2015-10-29 | 100 | 0 |
| K150855 | H-MAX S Femoral Hip System | Lima Corporate S.P.A. | 2015-10-21 | 204 | 0 |
| K151266 | Physica CR Knee System | Lima Corporate S.P.A. | 2015-10-06 | 146 | 0 |
| K143256 | SMR Modular Glenoid | Lima Corporate S.P.A. | 2015-05-28 | 196 | 0 |
| K141934 | PHYSICA KR KNEE SYSTEM | Lima Corporate S.P.A. | 2015-04-02 | 259 | 0 |
| K143509 | MasterSL femoral stem | Lima Corporate S.P.A. | 2015-01-27 | 47 | 0 |
| K142139 | SMR 40MM GLENOSPHERE | Lima Corporate S.P.A. | 2014-11-07 | 94 | 0 |
| K141327 | MINIMA S SYSTEM | Lima Corporate S.P.A. | 2014-08-06 | 77 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda