Data / Medical devices / Italy / Limacorporate S.p.A.
Limacorporate S.p.A.: FDA-registered device maker in Villanova di San Daniele Udine, Italy, 64 510(k) clearances
Limacorporate S.p.A. is registered with the FDA (registration 3008021110) in Villanova di San Daniele Udine, Italy. It lists 40 device types. The FDA files 64 510(k) clearances under its listings, the newest dated January 22, 2026. 12 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008021110
- Address
- Via Nazionale 52, Villanova di San Daniele Udine, Italy, 33038
- Owner or operator
- Limacorporate S.p.A. (10032506)
- Roles
- Manufacturer
- First device listed
- May 20, 2010
- Registered through
- 2027
- Brand names listed
- AMF TT Cones, ArTT, Awl, Bone Screws, Bone Screws 6.5mm, Bone screws 5mm, C2 Femoral Stem, CMD 23-1428 ProMade Elbow and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2026 | K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| August 29, 2025 | K251718 | ArTT Augments and Buttresses and Bone Screws | LPH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| July 3, 2025 | K243826 | SMR Reverse HP Shoulder System | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| May 22, 2025 | K250980 | Physica System (Physica CR Porous Femoral components) | MBH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| March 4, 2025 | K243809 | Biolox® Delta Revision heads | LZO | Substantially Equivalent | Limacorporate | accessdata.fda.gov |
| December 18, 2024 | K243615 | Physica Porous Femoral Components | MBH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| January 18, 2024 | K234011 | AMF TT Cones | JWH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| January 11, 2024 | K233712 | PRIMA Humeral System; PRIMA TT Glenoid | MBF | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| July 11, 2023 | K231925 | MINIMA S System | LZO | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| March 17, 2023 | K221758 | SMR Stemless Anatomic | PKC | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| October 26, 2022 | K222807 | TEMA Elbow system - Line extension | JDB | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| October 6, 2022 | K222427 | PRIMA TT Glenoid | MBF | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| May 19, 2022 | K220792 | SMR Reverse Liner | MBF | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| May 13, 2022 | K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | KWS | Substantially Equivalent | Limacorporate | accessdata.fda.gov |
| February 25, 2022 | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| December 17, 2021 | K213381 | Physica system | JWH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| July 12, 2021 | K210717 | Bone Screws dia. 5,0 mm | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| April 6, 2021 | K210554 | Physica system | MBH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| February 5, 2021 | K203475 | LimaCorporate Kirschner Wire | HTY | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| December 17, 2020 | K201905 | SMR 140° Reverse Humeral Body | MBF | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| December 14, 2020 | K201084 | Physica system | MBH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| November 19, 2020 | K200171 | SMR TT Augmented Glenoid System | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| July 8, 2020 | K200656 | Delta Multihole TT Pro Acetabular System | LPH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| May 7, 2020 | K200653 | AMF Revision TT Cones | JWH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| January 31, 2020 | K193284 | Physica LMC Knee System | JWH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| November 22, 2019 | K191746 | SMR TT Augmented Glenoid System | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| November 1, 2019 | K191622 | Delta Multihole TT Pro Acetabular System | LPH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| October 10, 2019 | K191963 | SMR Finned Short Stems | MBF | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| May 9, 2019 | K181491 | Delta Dual Mobility System | LZO | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| February 16, 2019 | K181362 | TEMA Elbow System | JDC | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| January 25, 2019 | K183042 | SMR Lateralized Connectors with screws | KWS | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| December 26, 2018 | K182099 | Delta TT Pro | LPH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| January 4, 2018 | K172456 | Bone Screws 6.5mm | LPH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| November 8, 2017 | K170473 | C2 femoral stem | LZO | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| June 29, 2017 | K163397 | SMR Hybrid Glenoid System | MBF | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| February 21, 2017 | K161120 | SMR TT Metal Back Glenoid, Bone Graft instruments | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| February 10, 2017 | K161226 | Revision Femoral Stem | LZO | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| August 22, 2016 | K160011 | H-Max S stem | MEH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| June 24, 2016 | K161476 | SMR Shoulder System | KWT | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| April 6, 2016 | K153722 | SMR 3-Pegs Glenoids | KWS | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| November 23, 2015 | K151739 | Revision Femoral Stem | LZO | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| October 29, 2015 | K152008 | Physica PS Knee System | JWH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| October 21, 2015 | K150855 | H-MAX S Femoral Hip System | MEH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| October 6, 2015 | K151266 | Physica CR Knee System | JWH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| May 28, 2015 | K143256 | SMR Modular Glenoid | KWS | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| April 2, 2015 | K141934 | PHYSICA KR KNEE SYSTEM | JWH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| November 7, 2014 | K142139 | SMR 40MM GLENOSPHERE | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| August 6, 2014 | K141327 | MINIMA S SYSTEM | LZO | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| June 30, 2014 | K141395 | DELTA TT ACETABULAR SYSTEM | LPH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| June 10, 2014 | K140975 | MASTERSL FEMORAL STEM | LZO | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| June 3, 2014 | K133349 | SMR TT METAL BACK GLENOID | KWS | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| June 12, 2013 | K130642 | SMR 3-PEGS GLENOIDS | KWS | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| June 7, 2013 | K131112 | LIMACORPORATE SMR CTA HUMERAL HEADS | KWS | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| December 21, 2012 | K112898 | DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS | LPH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| November 9, 2012 | K112091 | H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS | MEH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| June 1, 2012 | K112900 | SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS | HSD | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| May 10, 2012 | K112158 | MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS | LPH | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| February 24, 2012 | K113254 | SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| December 20, 2011 | K113523 | LIMACORPORATE SMR REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| August 18, 2011 | K110598 | SMR REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| July 28, 2011 | K111212 | SMR SHOULDER SYSTEM- REVISION STEMS | KWS | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| July 15, 2011 | K110847 | SMR SHOULDER SYSTEM - CTA HUMERAL HEADS | KWS | Substantially Equivalent | Lima Corporate S.P.A. | accessdata.fda.gov |
| January 28, 2011 | K101263 | LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, | KWT | Substantially Equivalent | Lima-Lto S.P.A. | accessdata.fda.gov |
| December 10, 2010 | K100858 | LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, | KWT | Substantially Equivalent | Lima-Lto S.P.A. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 19, 2025 | 96911 | Class II | Ongoing | PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile | There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. | accessdata.fda.gov |
| October 2, 2024 | 95732 | Class II | Ongoing | TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis. | Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. | accessdata.fda.gov |
| October 27, 2023 | 93329 | Class II | Ongoing | PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 | Due to incorrect product labeling | accessdata.fda.gov |
| August 29, 2023 | 93668 | Class II | Ongoing | PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLA | Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position. | accessdata.fda.gov |
| May 30, 2023 | 92459 | Class II | Ongoing | REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. | accessdata.fda.gov |
| February 21, 2023 | 91869 | Class II | Ongoing | SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation. | accessdata.fda.gov |
| January 25, 2023 | 91613 | Class II | Ongoing | TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) | Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. | accessdata.fda.gov |
| October 1, 2021 | 88812 | Class II | Terminated | REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852 | There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. | accessdata.fda.gov |
| September 8, 2017 | 78109 | Class II | Completed | Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System | An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved, leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses. | accessdata.fda.gov |
| July 21, 2016 | 74827 | Class II | Terminated | SMR allen wrench 5 mm, product code 9013.50.210 | Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles. | accessdata.fda.gov |
| April 8, 2016 | 73870 | Class II | Terminated | SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement. | Complaints of intra-operative breakage of the glenosphere impactors/extractors. | accessdata.fda.gov |
| August 14, 2015 | 71972 | Class II | Terminated | SMR Shoulder/Spalla Trial Humeral Head diameter.42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter.44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter.46 mm, REF 9013.22.465; for | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Guide, Surgical, Instrument
- All makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Updated January 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.