Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008395353

FEI Number

3008395353

Entity Name

Limacorporate S.p.A.

City/State/Country

Calatafimi Segesta (TP) Sicilia, IT

Establishment Address

Zona Industriale Contrada Fegotto, Calatafimi Segesta (TP) Sicilia 91013, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Limacorporate S.p.A. (Owner Number: 10032506)

Owner / Operator Contact Address

Via Nazionale 52, Villanova di San Daniele, IT-UD 33038, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TEMA Elbow System AMF TT Cones Delta TT Jumbo Cups SMR TT Metal Back Glenoid PRIMA TT Glenoid TEMA Elbow system SMR Stemless Anatomic Physica system Delta TT Pro CMD 25-1521 ProMade Hip CMD 24-1610 ProMade Hip CMD 25-1313 ProMade Hip CMD 25-1734 ProMade Hip CMD 26-1133 ProMade Hip CMD 25-1758 ProMade Hip CMD 25-1131 ProMade Hip CMD 25-1083 ProMade Hip CMD 25-1290 ProMade Hip CMD 26-1196 ProMade Hip CMD 25-1419 ProMade Hip CMD 25-1691 ProMade Hip CMD 25-1793 ProMade Hip CMD 26-1107 ProMade Hip CMD 25-1586 ProMade Hip CMD 25-1622 ProMade Hip CMD 26-1091 ProMade Hip CMD 25-1738 ProMade Hip CMD 26-1019 ProMade Hip CMD 26-1106 ProMade Hip CMD 24-1641 ProMade Hip CMD 25-1587 ProMade Hip CMD 25-1075 ProMade Hip CMD 25-1668 ProMade Hip CMD 25-1568 ProMade Hip CMD 25-1416 ProMade Hip CMD 25-1081 ProMade Hip CMD 25-1617 ProMade Hip CMD 25-1137 ProMade Hip CMD 25-1743 ProMade Hip CMD 24-1603 ProMade Hip CMD 25-1735 ProMade Hip CMD 26-1053 ProMade Hip CMD 25-1271 ProMade Hip CMD 26-1098 ProMade Hip CMD 25-1402 ProMade Hip CMD 25-1725 ProMade Hip CMD 25-1489 ProMade Hip CMD 25-1362 ProMade Hip CMD 25-1446 ProMade Hip CMD 25-1053 ProMade Hip CMD 25-1685 ProMade Hip CMD 25-1624 ProMade Hip CMD 25-1681 ProMade Hip CMD 26-1138 ProMade Hip CMD 25-1228 ProMade Hip CMD 24-1584 ProMade Hip CMD 25-1207 ProMade Hip CMD 25-1238 ProMade Hip AMF TT Cones CMD 26-1040 ProMade Shoulder CMD 25-1480 ProMade Shoulder CMD 25-1165 ProMade Shoulder CMD 25-1450 ProMade Shoulder CMD 25-1111 ProMade Shoulder CMD 25-1411 ProMade Shoulder CMD 25-1607 ProMade Shoulder CMD 24-1620 ProMade Shoulder CMD 26-1013 ProMade Shoulder CMD 25-1448 ProMade Shoulder CMD 25-1151 ProMade Shoulder CMD 25-1223 ProMade Shoulder CMD 25-1444 ProMade Shoulder CMD 25-1559 ProMade Shoulder CMD 25-1248 ProMade Shoulder CMD 25-1708 ProMade Shoulder CMD 25-1087 ProMade Shoulder CMD 25-1303 ProMade Shoulder CMD 25-1481 ProMade Shoulder CMD 26-1048 ProMade Shoulder CMD 26-1099 ProMade Shoulder CMD 24-1132 Promade Shoulder CMD 24-1380 ProMade Shoulder CMD 24-1410 ProMade Shoulder CMD 24-1375 ProMade Shoulder CMD 24-1470 ProMade Shoulder CMD 24-1347 ProMade Shoulder CMD 24-1456 ProMade Shoulder CMD 24-1446 ProMade Shoulder CMD 24-1509 ProMade Shoulder CMD 24-1486 ProMade Shoulder CMD 25-1176 ProMade Shoulder CMD 24-1422 ProMade Shoulder CMD 25-1024 ProMade Shoulder CMD 25-1253 ProMade Shoulder CMD 24-1629 ProMade Shoulder CMD 24-1592 ProMade Shoulder CMD 25-1136 ProMade Shoulder CMD 24-1457 ProMade Shoulder CMD 25-1233 ProMade Shoulder CMD 24-1616 ProMade Shoulder CMD 25-1637 ProMade Shoulder CMD 24-1429 ProMade Shoulder CMD 24-1556 ProMade Shoulder CMD 25-1357 ProMade Shoulder CMD 25-1110 ProMade Shoulder CMD 24-1240 ProMade Shoulder CMD 25-1631 ProMade Shoulder CMD 25-1675 ProMade Shoulder CMD 24-1365 ProMade Shoulder CMD 25-1704 ProMade Shoulder CMD 25-1603 ProMade Shoulder CMD 25-1369 ProMade Shoulder CMD 25-1395 ProMade Shoulder CMD 25-1568 ProMade Shoulder CMD 24-1224 ProMade Shoulder CMD 26-1036 ProMade Shoulder CMD 25-1549 ProMade Shoulder CMD 24-1481 ProMade Shoulder CMD 24-1263 ProMade Shoulder CMD 25-1071 ProMade Shoulder CMD 25-1770 ProMade Shoulder CMD 25-1724 ProMade Shoulder CMD 25-1642 ProMade Shoulder CMD 25-1794 ProMade Shoulder CMD 24-1362 ProMade Shoulder CMD 26-1169 ProMade Shoulder CMD 24-1327 ProMade Shoulder CMD 25-1596 ProMade Shoulder CMD 25-1785 ProMade Shoulder CMD 25-1652 ProMade Shoulder CMD 25-1038 ProMade Shoulder CMD 25-1336 ProMade Shoulder CMD 26-1086 ProMade Shoulder CMD 25-1610 ProMade Shoulder CMD 25-1164 ProMade Shoulder CMD 26-1065 ProMade Shoulder CMD 25-1611 ProMade Shoulder CMD 25-1217 ProMade Shoulder CMD 25-1752 ProMade Shoulder CMD 26-1020 ProMade Shoulder CMD 25-1464 ProMade Shoulder CMD 24-1423 ProMade Shoulder CMD 25-1274 ProMade Shoulder CMD 25-1079 ProMade Shoulder CMD 25-1466 ProMade Shoulder CMD 24-1542 ProMade Shoulder CMD 25-1356 ProMade Shoulder CMD 25-1042 ProMade Shoulder Delta Multihole TT Pro Acetabular System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2019-04-10
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2019-04-10
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-06-05
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-06-05
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2014-07-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-07-02
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-07-02
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-07-02
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2014-06-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2014-06-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2014-06-05
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-12-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-12-05
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2023-02-03
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2023-02-03
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2023-03-24
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-12-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-12-16
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2020-12-16
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-01-02
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2019-01-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-02-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-01-25
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-01-25
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-06-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-07-15
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2020-07-15

Official Correspondent

Roberto Gabetta

US Agent Details

Sherri Mellingen Email: Sherri.Mellingen@enovis.com Phone: (952) 9136383

Related Public Records

Same Entity

Limacorporate S.p.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020967480	ProMade PoC Center for Complex Orthopedic Solutions at HSS	Manhattan, NY, US
3008021110	Limacorporate S.p.A.	Villanova di San Daniele Udine, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K983036	Biomet, Inc.	SINGLE AXLE TOTAL ELBOW	1999-04-30
K040389	Zimmer, Inc.	COONRAD/MORREY ELBOW CEMENT RESTRICTOR	2004-05-17
K222566	Zimmer, Inc.	Zimmer Persona Personalized Knee System	2022-10-17
K252044	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	2025-10-24
K243247	Zimmer, Inc.	Persona the Personalized Knee System	2024-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
Z-0033-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008395353. Last updated year: 2026. Please use registration number 3008395353 when referencing this establishment in official correspondence.