FDA.reportPublic FDA data

Revision Knee System

Primary DI
00844588014239
Brand
Revision Knee System
Company
CONSENSUS ORTHOPEDICS, INC.
Model
2461-0-1112
Catalog number
2461-0-1112
Device description
Stem, Straight, Cementless
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844588014239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844588014239008445880142398445880142390844588014239

GMDN Terms#

Term, Definition table
TermDefinition
Revision coated hip femur prosthesisA sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter12Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100zjohnson@consensusortho.com

Regulatory Flags#

DUNS number
824905723
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844588000379Consensus® Bone Screw0013-1-65150013-1-65152015-09-24
00844588000386Consensus® Bone Screw0013-1-65200013-1-65202015-09-24
00844588000393Consensus® Bone Screw0013-1-65250013-1-65252015-09-24
00844588000409Consensus® Bone Screw0013-1-65300013-1-65302015-09-24
00844588000416Consensus® Bone Screw0013-1-65350013-1-65352015-09-24
00844588000423Consensus® Bone Screw0013-1-65400013-1-65402015-09-24
00844588000430Consensus® Bone Screw0013-1-65450013-1-65452015-09-24
00844588000447Consensus® Bone Screw0013-1-65500013-1-65502015-09-24
00844588010262Consensus® Bone Screw0013-1-65550013-1-65552015-09-24
00844588010279Consensus® Bone Screw0013-1-65600013-1-65602015-09-24
00844588010286Consensus® Bone Screw0013-1-65650013-1-65652015-09-24
00844588000010Consensus® Hip System0006-0-28010006-0-28012015-09-24
00844588000027Consensus® Hip System0006-0-28020006-0-28022015-09-24
00844588000034Consensus® Hip System0006-0-28030006-0-28032015-09-24
00844588000041Consensus® Hip System0006-0-32010006-0-32012015-09-24
00844588000058Consensus® Hip System0006-0-32020006-0-32022015-09-24
00844588000065Consensus® Hip System0006-0-32030006-0-32032015-09-24
00844588000072Consensus® Hip System0007-1-22010007-1-22012015-09-24
00844588000089Consensus® Hip System0007-1-22020007-1-22022015-09-24
00844588000096Consensus® Hip System0007-1-22030007-1-22032015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262192EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262208EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262215EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262222EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262239EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262246EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262253EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262260EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262277EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262284EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262291EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262307EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262314EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262321EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262338EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262345EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262352EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262369EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262376EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262383EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262390EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262406EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262413EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262420EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262437EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262444EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262451EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10