FDA.reportPublic FDA data

LinkSymphoKnee

Primary DI
04026575448630
Brand
LinkSymphoKnee
Company
WALDEMAR LINK GmbH & Co. KG
Model
ET18220
Catalog number
ET18220
Device description
Replacment Screw Tibial Augments
Published
2025-04-02
Public version status
Update
Distribution status
Not 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
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202924000LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021-05-13JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575448630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575448630040265754486304026575448630

GMDN Terms#

Term, Definition table
TermDefinition
Knee arthroplasty wedgeAn implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].

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
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29
03701089517515TRAXAMPLITUDE SASJWH2026-07-29
03701089517522TRAXAMPLITUDE SASJWH2026-07-29
03701089517539TRAXAMPLITUDE SASJWH2026-07-29
03701089517546TRAXAMPLITUDE SASJWH2026-07-29
03701089517553TRAXAMPLITUDE SASJWH2026-07-29
03701089517560TRAXAMPLITUDE SASJWH2026-07-29
03701089517577TRAXAMPLITUDE SASJWH2026-07-29
03701089517584TRAXAMPLITUDE SASJWH2026-07-29
03701089517591TRAXAMPLITUDE SASJWH2026-07-29
03701089517607TRAXAMPLITUDE SASJWH2026-07-29
03701089517614TRAXAMPLITUDE SASJWH2026-07-29
03701089517621TRAXAMPLITUDE SASJWH2026-07-29
03701089517638TRAXAMPLITUDE SASJWH2026-07-29
03701089517645TRAXAMPLITUDE SASJWH2026-07-29
03701089517652TRAXAMPLITUDE SASJWH2026-07-29
03701089517669TRAXAMPLITUDE SASJWH2026-07-29
03701089518390TRAXAMPLITUDE SASJWH2026-07-29