FDA.reportPublic FDA data

MRS

Primary DI
07613327048292
Brand
MRS
Company
Howmedica Osteonics Corp.
Model
6485-3-009
Catalog number
6485-3-009
Device description
Straight Cemented Stem
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040749000MODULAR REPLACEMENT SYSTEM CEMENTED STEMSHowmedica Osteonics Corp.2004-06-17KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327048292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327048292076133270482927613327048292

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. 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
Device Size Text, specify0
Device Size Text, specify0
Length102Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327012804V40 Head6260-4-2226260-4-2222015-09-24
07613327012811V40 Head6260-4-3226260-4-3222015-09-24
07613327012828V40 Head6260-5-0266260-5-0262015-09-24
07613327012835V40 Head6260-5-0286260-5-0282015-09-24
07613327012842V40 Head6260-5-0326260-5-0322015-09-24
07613327012859V40 Head6260-5-1266260-5-1262015-09-24
07613327012866V40 Head6260-5-1286260-5-1282015-09-24
07613327012873V40 Head6260-5-1326260-5-1322015-09-24
07613327012880V40 Head6260-5-2266260-5-2262015-09-24
07613327012897V40 Head6260-5-2286260-5-2282015-09-24
07613327012903V40 Head6260-5-2326260-5-2322015-09-24
07613327012941V40 Head6260-5-4266260-5-4262015-09-24
07613327012958V40 Head6260-5-4286260-5-4282015-09-24
07613327012965V40 Head6260-5-4326260-5-4322015-09-24
07613327012972V40 Head6260-5-6286260-5-6282015-09-24
07613327019704Restoration5096-46255096-46252015-09-24
07613327019711Restoration5096-46155096-46152015-09-24
07613327019728Restoration5096-46205096-46202015-09-24
07613327019735Restoration5096-50155096-50152015-09-24
07613327019742Restoration5096-50205096-50202015-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10603295529804ATTUNEDEPUY (IRELAND)KRO2025-10-31
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10603295529828ATTUNEDEPUY (IRELAND)KRO2025-10-31
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10603295529903ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529910ATTUNEDEPUY (IRELAND)KRO2025-10-31
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10603295529934ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529941ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529958ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529965ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529972ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529989ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529996ATTUNEDEPUY (IRELAND)KRO2025-10-31