FDA.reportPublic FDA data

Oxford® Partial Knee System

Primary DI
00880304525672
Brand
Oxford® Partial Knee System
Company
Biomet Uk Ltd
Model
32-422097
Catalog number
32-422097
Published
2025-01-10
Public version status
Update
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
P010014105

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010014105OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304525672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304525672008803045256728803045256720880304525672

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

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
Lot or batch
true
Manufacturing date on label
true
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