FDA.reportPublic FDA data

Oxford® Partial Knee System

Primary DI
00889024683556
Brand
Oxford® Partial Knee System
Company
Biomet Uk Ltd
Model
113021300
Catalog number
113021300
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
00889024683556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024683556008890246835568890246835560889024683556

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. 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
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