FDA.reportPublic FDA data

Oxford Partial Knee System

Primary DI
00880304510197
Brand
Oxford Partial Knee System
Company
Biomet Orthopedics, LLC
Model
42-411420
Catalog number
42-411420
Device description
Signature Tibial Drill Guide
Published
2014-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
P010014031

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010014031OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMBiomet Manufacturing Corp2004-04-21NRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304510197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304510197008803045101978803045101970880304510197

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-348-9500customerservice@biomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

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