FDA.reportPublic FDA data

Oxford® Partial Knee System

Primary DI
00889024683778
Brand
Oxford® Partial Knee System
Company
Biomet Uk Ltd
Model
116000000
Catalog number
116000000
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
00889024683778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024683778008890246837788890246837780889024683778

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. 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