LISI MEDICAL ORTHOPAEDICS

FDA Device Registration & Listing · HEROUVILLE ST CLAIR CEDEX Normandie, FR · Registration 3008556682

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008556682
FEI Number
3008556682
Entity Name
LISI MEDICAL ORTHOPAEDICS
City/State/Country
HEROUVILLE ST CLAIR CEDEX Normandie, FR
Establishment Address
203 BD de la Grande Delle, BP 8, HEROUVILLE ST CLAIR CEDEX Normandie 14201, FR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PRECERA Medical HEROUVILLE (Owner Number: 10094563)
Owner / Operator Contact Address
203 bld de la Grande Delle, HEROUVILLE SAINT CLAIR, FR-14 14200, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Trathlon Hinge Knee system - small Citation HIP CUSTOMS MULTIPLE ORTHOPED. MANUAL INSTRUMEN TRIDENT MDM MONOPOLAR EXTENSION ACCOLADE Citation Stem Dual Mobility Liner & X3 Insert Exeter Hip System Trident Acetabular System TRIDENT TRIDENT II CLUSTERHOLE HA 42A TRIDENT II PSL CLUSTERHOLE HA 60G TRIDENT II CLUSTERHOLE HA 48D TRIDENT II PSL CLUSTERHOLE HA 50D TRIDENT II PSL CLUSTERHOLE HA 52E TRIDENT II PSL CLUSTERHOLE HA 62G TRIDENT II CLUSTERHOLE HA 66H TRIDENT II CLUSTERHOLE HA 44B TRIDENT II CLUSTERHOLE HA 54E TRIDENT II PSL CLUSTERHOLE HA 44B TRIDENT II PSL CLUSTERHOLE HA 58F TRIDENT II CLUSTERHOLE HA 46C TRIDENT II PSL CLUSTERHOLE HA 42A TRIDENT II PSL CLUSTERHOLE HA 48D TRIDENT II CLUSTERHOLE HA 56F TRIDENT II CLUSTERHOLE HA 64H TRIDENT II CLUSTERHOLE HA 62G TRIDENT II PSL CLUSTERHOLE HA 46C TRIDENT II PSL CLUSTERHOLE HA 64H TRIDENT II CLUSTERHOLE HA 60G TRIDENT II PSL CLUSTERHOLE HA 66H TRIDENT II CLUSTERHOLE HA 58F TRIDENT II PSL CLUSTERHOLE HA 54E TRIDENT II CLUSTERHOLE HA 50D TRIDENT II PSL CLUSTERHOLE HA 56F TRIDENT II CLUSTERHOLE HA 52E OMNIFIT No Proprietary Name listed on FURLS Omnifit Trident Shells TRIDENT (TRITANIUM REVISION ACETABULAR) Triathlon Hinge knee system SUP FEMORAL STEMS OMNIFIT Exeter Mesh REUNION S No Proprietary Name listed on FURLS Femoral Head

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2025-12-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-12-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-08
HWT Template Orthopedic Class 1 888.4800 2025-12-08
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2025-12-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-08
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2025-12-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-08
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2025-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-08
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2025-12-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-12-08
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2025-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-08
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis General, Plastic Surgery Class 2 878.3300 2025-12-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-12-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2025-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2025-12-08

Official Correspondent

Gaelle TRECHOT

US Agent Details

Claire BROWN Email: Claire.Brown@preceramedical.com Phone: (763) 2302935

Related Public Records

Same Entity

PRECERA Medical HEROUVILLE
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K220628 Waldemar Link GmbH & Co. KG LINK Endo-Model EVO Knee System 2022-05-03
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21
K140975 Lima Corporate S.P.A. MASTERSL FEMORAL STEM 2014-06-10
K932222 Dow Corning Wright SLT FEMORAL HEAD 1994-05-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011 Depuy Orthopaedics, Inc. 1
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008556682. Last updated year: 2026. Please use registration number 3008556682 when referencing this establishment in official correspondence.
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