FDA.reportPublic FDA data

Restoration

Primary DI
07613327017878
Brand
Restoration
Company
Howmedica Osteonics Corp.
Model
6013-1014
Catalog number
6013-1014
Device description
Hip Stem
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944836000OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIESOsteonics Corp.1995-04-10MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327017878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327017878076133270178787613327017878

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24