FDA.reportPublic FDA data

Oxford Partial Knee System

Primary DI
05019279388127
Brand
Oxford Partial Knee System
Company
Biomet Uk Ltd
Model
154606
Catalog number
154606
Published
2014-08-29
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
NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile BearingUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010014000
P010014001
P010014004
P010014005
P010014006
P010014009
P010014015
P010014016
P010014018
P010014020
P010014021
P010014024
P010014027
P010014028
P010014030
P010014031
P010014032
P010014033
P010014035
P010014036
P010014037
P010014039
P010014048
P010014067

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010014000OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014001OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014004OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014005OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014006OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014009OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014015OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014016OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014018OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014020OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014021OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014024OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014027OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014028OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014030OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014031OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014032OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014033OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014035OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014036OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014037OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014039OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014048OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA
P010014067OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05019279388127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05019279388127050192793881275019279388127

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee prosthesisA sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length38Millimeter
Width26Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-348-9500customerservice@biomet.com
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
219322575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024683808Oxford® Partial Knee System5122111155122111152026-04-09
00889024683815Oxford® Partial Knee System5122111505122111502026-04-09
00889024683181Oxford® Partial Knee System1122111001122111002026-04-03
00889024683198Oxford® Partial Knee System1122112001122112002026-04-03
00889024683204Oxford® Partial Knee System1122113001122113002026-04-03
00889024683211Oxford® Partial Knee System1122114001122114002026-04-03
00889024683228Oxford® Partial Knee System1122115001122115002026-04-03
00889024683235Oxford® Partial Knee System1122116001122116002026-04-03
00889024683242Oxford® Partial Knee System1122117001122117002026-04-03
00889024683259Oxford® Partial Knee System1122211001122211002026-04-03
00889024683266Oxford® Partial Knee System1122212001122212002026-04-03
00889024683273Oxford® Partial Knee System1122213001122213002026-04-03
00889024683280Oxford® Partial Knee System1122214001122214002026-04-03
00889024683297Oxford® Partial Knee System1122215001122215002026-04-03
00889024683303Oxford® Partial Knee System1122216001122216002026-04-03
00889024683310Oxford® Partial Knee System1122217001122217002026-04-03
00889024683327Oxford® Partial Knee System1123111001123111002026-04-03
00889024683334Oxford® Partial Knee System1123112001123112002026-04-03
00889024683341Oxford® Partial Knee System1123113001123113002026-04-03
00889024683358Oxford® Partial Knee System1123114001123114002026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024683181Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683198Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683204Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683211Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683228Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683235Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683242Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683259Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683266Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683273Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683280Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683297Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683303Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683310Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683327Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683334Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683341Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683358Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683365Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683372Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683389Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683396Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683402Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683419Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683426Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683433Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683440Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683457Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683464Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03
00889024683471Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-04-03