FDA.reportPublic FDA data

Endo-Model Modular Knee Prosthesis System

Primary DI
04026575431663
Brand
Endo-Model Modular Knee Prosthesis System
Company
WALDEMAR LINK GmbH & Co. KG
Model
15-3950/04
Catalog number
15-3950/04
Device description
Modular Stem
Published
2016-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152431000
K212742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152431000LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coatingWaldemar Link GmbH & Co. KG2016-05-09KRO
K212742000GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coatingWaldemar Link GmbH & Co. KG2021-09-16JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575431663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575431663040265754316634026575431663

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur stem prosthesisA sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315675488
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026575448678MobileLink Acetabular Cup System183-353/40183-353/402026-07-09
04026575448685MobileLink Acetabular Cup System183-363/40183-363/402026-07-09
04026575448760MobileLink Acetabular Cup System183-354/40183-354/402026-07-09
04026575448777MobileLink Acetabular Cup System183-355/40183-355/402026-07-09
04026575448784MobileLink Acetabular Cup System183-356/40183-356/402026-07-09
04026575448791MobileLink Acetabular Cup System183-364/40183-364/402026-07-09
04026575448807MobileLink Acetabular Cup System183-365/40183-365/402026-07-09
04026575448814MobileLink Acetabular Cup System183-366/40183-366/402026-07-09
04026575448821MobileLink Acetabular Cup System183-373/40183-373/402026-07-09
04026575448838MobileLink Acetabular Cup System183-374/40183-374/402026-07-09
04026575448845MobileLink Acetabular Cup System183-375/40183-375/402026-07-09
04026575448852MobileLink Acetabular Cup System183-376/40183-376/402026-07-09
04026575448869MobileLink Acetabular Cup System183-743/40183-743/402026-07-09
04026575448876MobileLink Acetabular Cup System183-744/40183-744/402026-07-09
04026575448883MobileLink Acetabular Cup System183-745/40183-745/402026-07-09
04026575448890MobileLink Acetabular Cup System183-746/40183-746/402026-07-09
04026575348213SPII Model Lubinus128-950/35128-950/352015-11-01
04026575348220SPII Model Lubinus128-951/35128-951/352015-11-01
04026575348237SPII Model Lubinus128-952/35128-952/352015-11-01
04026575348244SPII Model Lubinus128-953/35128-953/352015-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B278AM25002200C0ELEOS™ Limb Salvage System with NanoCept® TechnologyONKOS SURGICAL, INC.KRO2026-06-09
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19
00888867106697Arthrex®ARTHREX, INC.HSX2017-02-15
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
00848486016401MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016418MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016432MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016449MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016456MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016463MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016487MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016494MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016500MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016517MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016531MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016548MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016555MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016562MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016586MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016593MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016609MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016616MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016630MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016647MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016654MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016661MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016685MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016692MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016708MakoMAKO SURGICAL CORP.HSX2015-11-04