FDA.reportPublic FDA data

GENESIS II

Primary DI
00885556049815
Brand
GENESIS II
Company
Smith & Nephew, Inc.
Model
71930117
Catalog number
71930117
Device description
TRI/GENII TIB ISRT 18 SZ 1-2 LT
Published
2015-09-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBVProsthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833200000TRICON M TOTAL KNEE SYSTEMRichards Medical Co., Inc.1983-11-29MBV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556049815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556049815008855560498158855560498150885556049815

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia prosthesis, polyethyleneAn implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made entirely of polyethylene (PE) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@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
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30
03596010544230JOURNEY71461016714610162015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00880304004528BIOMET® PROVISIONALBiomet Orthopedics, LLCMBV2017-07-28
00880304000438BIOMET KNEEBiomet Orthopedics, LLCMBV2016-09-22
00880304011380BIOMET KNEEBiomet Orthopedics, LLCMBV2016-09-22
00880304011397BIOMET KNEEBiomet Orthopedics, LLCMBV2016-09-22
08428898831230BIOMET KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
08428898831209BIOMET KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304000025BIOMET KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304000056BIOMET KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304000070Biomet Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304000087BIOMET KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304000643MAXIM KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304000766BIOMET KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304000834BIOMET KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304000872Ascent Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304000889Ascent Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304000919Ascent Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304000957MAXIM KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304000964Biomet Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304000971Biomet® Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304001022MAXIM KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304001299Biomet® Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304001305Biomet® Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304001312Biomet® Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304001343Biomet® Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304001350Biomet® Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304001374MAXIM KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304001398MAXIM® KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24
00880304001428Biomet® Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304001459Maxim Knee SystemBiomet Orthopedics, LLCMBV2015-10-24
00880304001466BIOMET KNEE SYSTEMBiomet Orthopedics, LLCMBV2015-10-24