Company · IT
Lima Corporate S.P.A.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
64510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 11 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 8 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 8 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 8 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 8 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 7 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 4 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 1 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 1 |
| QHE | Shoulder Arthroplasty Implantation System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 2026 | K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System Lima Corporate S.P.A., IT | PHX |
| Aug 29, 2025 | K251718 | ArTT Augments and Buttresses and Bone Screws Lima Corporate S.P.A., IT | LPH |
| Jul 3, 2025 | K243826 | SMR Reverse HP Shoulder System Lima Corporate S.P.A., IT | PHX |
| May 22, 2025 | K250980 | Physica System (Physica CR Porous Femoral components) Lima Corporate S.P.A., IT | MBH |
| Dec 18, 2024 | K243615 | Physica Porous Femoral Components Lima Corporate S.P.A., IT | MBH |
| Jan 18, 2024 | K234011 | AMF TT Cones Lima Corporate S.P.A., IT | JWH |
| Jan 11, 2024 | K233712 | PRIMA Humeral System; PRIMA TT Glenoid Lima Corporate S.P.A., IT | MBF |
| Dec 21, 2023 | K231099 | SMR Hybrid Glenoid System Lima Corporate S.P.A., IT | MBF |
| Jul 11, 2023 | K231925 | MINIMA S System Lima Corporate S.P.A., IT | LZO |
| Mar 17, 2023 | K221758 | SMR Stemless Anatomic Lima Corporate S.P.A., IT | PKC |
| Feb 3, 2023 | K223876 | SMR Shoulder System Lima Corporate S.P.A., IT | MBF |
| Dec 20, 2022 | K222405 | Smart SPACE Shoulder Planner and 3D Positioners Lima Corporate S.P.A., IT | QHE |
| Oct 26, 2022 | K222807 | TEMA Elbow system - Line extension Lima Corporate S.P.A., IT | JDB |
| Oct 6, 2022 | K222427 | PRIMA TT Glenoid Lima Corporate S.P.A., IT | MBF |
| May 19, 2022 | K220792 | SMR Reverse Liner Lima Corporate S.P.A., IT | MBF |
| Feb 25, 2022 | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 Lima Corporate S.P.A., IT | PHX |
| Dec 17, 2021 | K213381 | Physica system Lima Corporate S.P.A., IT | JWH |
| Jul 12, 2021 | K210717 | Bone Screws dia. 5,0 mm Lima Corporate S.P.A., IT | PHX |
| Apr 6, 2021 | K210554 | Physica system Lima Corporate S.P.A., IT | MBH |
| Feb 5, 2021 | K203475 | LimaCorporate Kirschner Wire Lima Corporate S.P.A., IT | HTY |
| Dec 17, 2020 | K201905 | SMR 140° Reverse Humeral Body Lima Corporate S.P.A., IT | MBF |
| Dec 14, 2020 | K201084 | Physica system Lima Corporate S.P.A., IT | MBH |
| Nov 19, 2020 | K200171 | SMR TT Augmented Glenoid System Lima Corporate S.P.A., IT | PHX |
| Jul 8, 2020 | K200656 | Delta Multihole TT Pro Acetabular System Lima Corporate S.P.A., IT | LPH |
| May 7, 2020 | K200653 | AMF Revision TT Cones Lima Corporate S.P.A., IT | JWH |
| Jan 31, 2020 | K193284 | Physica LMC Knee System Lima Corporate S.P.A., IT | JWH |
| Nov 22, 2019 | K191746 | SMR TT Augmented Glenoid System Lima Corporate S.P.A., IT | PHX |
| Nov 1, 2019 | K191622 | Delta Multihole TT Pro Acetabular System Lima Corporate S.P.A., IT | LPH |
| Oct 10, 2019 | K191963 | SMR Finned Short Stems Lima Corporate S.P.A., IT | MBF |
| May 9, 2019 | K181491 | Delta Dual Mobility System Lima Corporate S.P.A., IT | LZO |
| Feb 16, 2019 | K181362 | TEMA Elbow System Lima Corporate S.P.A., IT | JDC |
| Jan 25, 2019 | K183042 | SMR Lateralized Connectors with screws Lima Corporate S.P.A., IT | KWS |
| Dec 26, 2018 | K182099 | Delta TT Pro Lima Corporate S.P.A., IT | LPH |
| Jan 4, 2018 | K172456 | Bone Screws 6.5mm Lima Corporate S.P.A., IT | LPH |
| Nov 8, 2017 | K170473 | C2 femoral stem Lima Corporate S.P.A., IT | LZO |
| Jun 29, 2017 | K163397 | SMR Hybrid Glenoid System Lima Corporate S.P.A., IT | MBF |
| Feb 21, 2017 | K161120 | SMR TT Metal Back Glenoid, Bone Graft instruments Lima Corporate S.P.A., IT | PHX |
| Feb 10, 2017 | K161226 | Revision Femoral Stem Lima Corporate S.P.A., IT | LZO |
| Aug 22, 2016 | K160011 | H-Max S stem Lima Corporate S.P.A., IT | MEH |
| Jun 24, 2016 | K161476 | SMR Shoulder System Lima Corporate S.P.A., IT | KWT |
| Apr 6, 2016 | K153722 | SMR 3-Pegs Glenoids Lima Corporate S.P.A., IT | KWS |
| Nov 23, 2015 | K151739 | Revision Femoral Stem Lima Corporate S.P.A., IT | LZO |
| Oct 29, 2015 | K152008 | Physica PS Knee System Lima Corporate S.P.A., IT | JWH |
| Oct 21, 2015 | K150855 | H-MAX S Femoral Hip System Lima Corporate S.P.A., IT | MEH |
| Oct 6, 2015 | K151266 | Physica CR Knee System Lima Corporate S.P.A., IT | JWH |
| May 28, 2015 | K143256 | SMR Modular Glenoid Lima Corporate S.P.A., IT | KWS |
| Apr 2, 2015 | K141934 | PHYSICA KR KNEE SYSTEM Lima Corporate S.P.A., IT | JWH |
| Jan 27, 2015 | K143509 | MasterSL femoral stem Lima Corporate S.P.A., IT | LZO |
| Nov 7, 2014 | K142139 | SMR 40MM GLENOSPHERE Lima Corporate S.P.A. | PHX |
| Aug 6, 2014 | K141327 | MINIMA S SYSTEM Lima Corporate S.P.A. | LZO |
Newest 50 of 64.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||