FDA.reportPublic FDA data

Vanguard XP® Instrumentation

Primary DI
00880304615854
Brand
Vanguard XP® Instrumentation
Company
Biomet Orthopedics, LLC
Model
32-700284
Catalog number
32-700284
Published
2021-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304615854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304615854008803046158548803046158540880304615854

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trialA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
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