FDA.reportPublic FDA data

LCS

Primary DI
10603295007906
Brand
LCS
Company
DEPUY ORTHOPAEDICS, INC.
Model
1178-34-025
Catalog number
117834025
Device description
LCS TIBIAL INSERT MENISCAL BEARING LG+ 15mm
Published
2015-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJLProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile BearingUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295007906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500790610603295007906

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
080506581
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295562108VELYS Hip Navigation4515801514515801512026-03-24
10603295553625ATTUNE2999-67-0322999670322026-02-17
10603295553632ATTUNE2999-67-0332999670332026-02-17
10603295553649ATTUNE2999-67-0342999670342026-02-17
10603295553656ATTUNE2999-67-0352999670352026-02-17
10603295554974EMPHASYS2999-67-0462999670462026-02-04
10603295080121AML EXCEL2001-65-0002001650002018-06-15
10603295082408DURALOC2015-24-0002015240002018-09-24
10603295083382SIGMA2024-57-1112024571112018-09-24
10603295084075SIGMA2024-85-0052024850052018-09-24
10603295088042GLOBAL FX2128-01-0222128010222018-09-24
10603295090540GLOBAL AP2130-01-0552130010552018-09-24
10603295090687GLOBAL AP2130-04-0002130040002018-09-24
10603295094005NA2178-30-1222178301222018-09-24
10603295095651LCS COMPLETION2178-60-0282178600282018-09-24
10603295096184NA2178-63-1242178631242018-09-24
10603295096191NA2178-63-1262178631262018-09-24
10603295098935PINNACLE2217-50-0042217500042018-09-24
10603295098942PINNACLE2217-50-0052217500052018-09-24
10603295098959PINNACLE2217-50-0062217500062018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295503309ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503316ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503323ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503330ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503347ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503354ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503361ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503378ATTUNEDEPUY (IRELAND)NJL2026-01-13
00889024665118NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665125NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665132NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665149NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665156NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665163NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665170NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665187NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665194NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665200NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665217NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665224NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665231NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665248NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665255NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665262NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665279NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665286NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665293NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665309NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665316NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665323NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05