FDA.reportPublic FDA data

Legion

Primary DI
00885556645604
Brand
Legion
Company
Smith & Nephew, Inc.
Model
71935408
Catalog number
71935408
Device description
LEGION FEM CONE ID 20MM RIGHT
Published
2017-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162775000
K230653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162775000Legion Cone SystemSmith & Nephew, Inc.2017-01-13JWH
K230653000Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial BaseplatesSmith & Nephew, Inc.2023-05-04JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556645604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556645604008855566456048855566456040885556645604

GMDN Terms#

Term, Definition table
TermDefinition
Knee arthroplasty wedgeA sterile device designed to augment the implantation of a knee femur or tibia prosthesis by acting as a space-filler adjacent to the prosthesis, typically to replace lost bone. 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010194534SYNERGY71306709713067092015-08-30
03596010194541SYNERGY71306710713067102015-08-30
03596010194558SYNERGY71306711713067112015-08-30
03596010194565SYNERGY71306712713067122015-08-30
03596010194572SYNERGY71306713713067132015-08-30
03596010194589SYNERGY71306714713067142015-08-30
03596010194596SYNERGY71306715713067152015-08-30
03596010194602SYNERGY71306716713067162015-08-30
03596010194619SYNERGY71306717713067172015-08-30
03596010194626SYNERGY71306718713067182015-08-30
03596010384935SYNERGY71306409713064092015-08-29
03596010384942SYNERGY71306410713064102015-08-29
03596010384966SYNERGY71306411713064112015-08-29
03596010384973SYNERGY71306412713064122015-08-29
03596010384980SYNERGY71306413713064132015-08-30
03596010384997SYNERGY71306414713064142015-08-30
03596010385000SYNERGY71306415713064152015-08-30
03596010385017SYNERGY71306416713064162015-08-30
03596010385024SYNERGY71306417713064172015-08-30
03596010385031SYNERGY71306418713064182015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVMBH2026-05-28
05404028001257SurgiCase PlannerMaterialise NVJWH2026-05-28
07613327014846TriathlonHowmedica Osteonics Corp.MBH2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000023INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000030INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000047INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000054INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000061INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000078INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000085INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000092INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000108INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000115INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000122INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000139INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000146INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000153INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000160INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000177INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000184INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000191INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000207INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000214INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000221INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000238INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000245INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000252INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000269INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000276INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24