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
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442433450SignatureMaterialise NVMBV2026-09-24
E31442433460SignatureMaterialise NVMBV2026-09-24
E31442433470SignatureMaterialise NVMBV2026-09-24
E31442433550SignatureMaterialise NVMBV2026-09-24
E31442433560SignatureMaterialise NVMBV2026-09-24
E31442433570SignatureMaterialise NVMBV2026-09-24
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