FDA.reportPublic FDA data

Oxford® Partial Knee System

Primary DI
00889024683648
Brand
Oxford® Partial Knee System
Company
Biomet Uk Ltd
Model
113111500
Catalog number
113111500
Published
2026-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P010014109

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010014109OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024683648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024683648008890246836488890246836480889024683648

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trial, reusableA 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.

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
219322575
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024682481Oxford® Partial Knee System1101101031101101032026-09-04
00889024682498Oxford® Partial Knee System1101101041101101042026-09-04
00889024682504Oxford® Partial Knee System1101101051101101052026-09-04
00889024682528Oxford® Partial Knee System1101101071101101072026-09-04
00889024682535Oxford® Partial Knee System1101101081101101082026-09-04
00889024682542Oxford® Partial Knee System1101101091101101092026-09-04
00889024682559Oxford® Partial Knee System1101102031101102032026-09-04
00889024682566Oxford® Partial Knee System1101102041101102042026-09-04
00889024682573Oxford® Partial Knee System1101102051101102052026-09-04
00889024682580Oxford® Partial Knee System1101102061101102062026-09-04
00889024682603Oxford® Partial Knee System1101102081101102082026-09-04
00889024682610Oxford® Partial Knee System1101102091101102092026-09-04
00889024682634Oxford® Partial Knee System1101103041101103042026-09-04
00889024682641Oxford® Partial Knee System1101103051101103052026-09-04
00889024682665Oxford® Partial Knee System1101103071101103072026-09-04
00889024682672Oxford® Partial Knee System1101103081101103082026-09-04
00889024682696Oxford® Partial Knee System1101104031101104032026-09-04
00889024682719Oxford® Partial Knee System1101104051101104052026-09-04
00889024682733Oxford® Partial Knee System1101104071101104072026-09-04
00889024682757Oxford® Partial Knee System1101104091101104092026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024682481Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682498Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682504Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682528Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682535Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682542Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682559Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682566Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682573Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682580Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682603Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682610Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682634Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682641Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682665Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682672Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682696Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682719Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682733Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682757Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682764Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682788Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682795Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682801Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682825Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682849Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682863Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682870Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682887Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04
00889024682900Oxford® Partial Knee SystemBiomet Uk LtdNRA2026-09-04