FDA.report

VANGUARD® COMPLETE KNEE SYSTEM

Primary DI
00880304991385
Brand
VANGUARD® COMPLETE KNEE SYSTEM
Company
Biomet Orthopedics, LLC
Model
195530
Catalog number
195530
Published
2020-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304991385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304991385008803049913858803049913850880304991385

GMDN Terms

TermDefinition
Uncoated knee tibia/insert prosthesisA sterile 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 of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it includes a polyethylene (PE) insert/platform for femoral articulation. Device implantation is intended to be performed with bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags

DUNS number
129278169
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00889024704527Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2026-01-08
00889024704671Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2026-01-08
00889024704893Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2026-01-08
00889024704534Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2025-12-23
00889024704572Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2025-12-23
00889024704596Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2025-12-23
00889024704640Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2025-12-23
00889024704688Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2025-12-23
00889024704701Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2025-12-23
00889024704725Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2025-12-23
00889024704794Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2025-12-23
00889024704817Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCMBV2025-12-23
00887868562082Vanguard® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562112Vanguard® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562136Vanguard® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562143Vanguard® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562174Vanguard® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562198Vanguard® InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562266Biomet® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562273Biomet® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562297Vanguard® 360 Instrument OsseoTi®Biomet Orthopedics, LLCMBV2023-07-05
00887868562303Vanguard® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562327Vanguard® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562334Vanguard® InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562389Vanguard® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562396Vanguard® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562402Biomet® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562433Biomet® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562488Biomet® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05
00887868562501Biomet® 360 InstrumentBiomet Orthopedics, LLCMBV2023-07-05