FDA.reportPublic FDA data

Oxford®

Primary DI
00887868485084
Brand
Oxford®
Company
Biomet Orthopedics, LLC
Model
32-423026
Catalog number
32-423026
Published
2021-04-02
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
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133940000OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)Biomet UK, Ltd.2014-03-28HRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868485084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868485084008878684850848878684850840887868485084

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur prosthesis trialA copy of a final femur 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 tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device intended to be sterilized prior to use.

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
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442411410SignatureMaterialise NVHRY2026-09-24
E31442422650SignatureMaterialise NVHRY2026-09-24
E31442422651SignatureMaterialise NVHRY2026-09-24
E31442422652SignatureMaterialise NVHRY2026-09-24
E31442422653SignatureMaterialise NVHRY2026-09-24
E31442422660SignatureMaterialise NVHRY2026-09-24
E31442422661SignatureMaterialise NVHRY2026-09-24
E31442422662SignatureMaterialise NVHRY2026-09-24
E31442422663SignatureMaterialise NVHRY2026-09-24
E31442422670SignatureMaterialise NVHRY2026-09-24
E31442422671SignatureMaterialise NVHRY2026-09-24
E31442422672SignatureMaterialise NVHRY2026-09-24
E31442422673SignatureMaterialise NVHRY2026-09-24
00192629082854EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082922EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082939EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082946EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082953EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082960EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082977EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082984EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082991EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083004EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083011EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18