Company · IT
Limacorporate S.p.A
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2025. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 4 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 |
| LXH | Orthopedic Manual Surgical Instrument | 2 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 2 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 1 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2025 | K243809 | Biolox® Delta Revision heads Limacorporate, IT | LZO |
| May 13, 2022 | K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid Limacorporate, IT | KWS |
| Jul 13, 2021 | K211938 | Physica LMC Knee System Limacorporate, IT | JWH |
| Nov 26, 2019 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner Limacorporate, IT | JWH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2025 | Limacorporate S.p.A PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile Open, Classified |
PHX | K212800 |
| Jun 25, 2025 | Limacorporate S.p.A PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile Open, Classified |
PHX | K212800 |
| Dec 20, 2024 | Limacorporate S.p.A 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. Open, Classified |
JDB | K222807 |
| Jan 12, 2024 | Limacorporate S.p.A 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/ Open, Classified |
MBF | K222427 |
| Dec 9, 2023 | Limacorporate S.p.A PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 Open, Classified |
JWH | K213381 |
| Jun 27, 2023 | Limacorporate S.p.A REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R Open, Classified |
MBF | K222427 |
| Jun 27, 2023 | Limacorporate S.p.A REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R Open, Classified |
MBF | K222427 |
| Apr 1, 2023 | Limacorporate S.p.A SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 Open, Classified |
MBF | K163397 |
| Mar 16, 2023 | Limacorporate S.p.A TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) Open, Classified |
JDC | K181362 |
| Oct 1, 2021 | Limacorporate S.p.A REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845 Terminated |
LPH | K172456 |
| Oct 1, 2021 | Limacorporate S.p.A REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852 Terminated |
LPH | K172456 |
| Sep 8, 2017 | Limacorporate S.p.A Delta Cup Beater Positioner - Aligner, model # 9057.20.555
Used during implantation of the Delta Acetabular System Completed |
LXH | K141395 |
| Aug 31, 2016 | Limacorporate S.p.A SMR allen wrench 5 mm, product code 9013.50.210 Terminated |
LXH | None listed |
| Apr 8, 2016 | Limacorporate S.p.A SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement. Terminated |
KWS | K110598 |
| Sep 2, 2015 | Limacorporate S.p.A SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery. Terminated |
HSD | K100858 |
| Sep 2, 2015 | Limacorporate S.p.A 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 Terminated |
KWT | K100858 |