FDA.reportPublic FDA data

Restoration

Primary DI
07613153071280
Brand
Restoration
Company
Howmedica Osteonics Corp.
Model
6276-2-019
Catalog number
6276-2-019
Device description
Modular Hip System
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613153071280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613153071280076131530712807613153071280

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327128420Simplex6197-9-0016197-9-0012017-06-19
07613327128437Simplex6188-1-0016188-1-0012015-09-24
07613327128444Simplex6191-1-0016191-1-0012015-09-24
07613327128451Simplex6192-1-0016192-1-0012017-06-19
07613327181531INSTRUMENT0901-1-0000901-1-0002016-09-24
07613327020786Secur-Fit6054-0509S6054-0509S2015-09-24
07613327020793Secur-Fit6054-0511S6054-0511S2015-09-24
07613327020809Secur-Fit6054-0610S6054-0610S2015-09-24
07613327020816Secur-Fit6054-0612S6054-0612S2015-09-24
07613327020823Secur-Fit6054-0812S6054-0812S2015-09-24
07613327020830Secur-Fit6054-0713S6054-0713S2015-09-24
07613327020847Secur-Fit6054-0711S6054-0711S2015-09-24
07613327020854Secur-Fit6054-0814S6054-0814S2015-09-24
07613327020861Secur-Fit6054-0913S6054-0913S2015-09-24
07613327020878Secur-Fit6054-1014S6054-1014S2015-09-24
07613327020885Secur-Fit6054-1016S6054-1016S2015-09-24
07613327020892Secur-Fit6054-0915S6054-0915S2015-09-24
07613327020908Secur-Fit6054-1115S6054-1115S2015-09-24
07613327020915Secur-Fit6054-1117S6054-1117S2015-09-24
07613327020922Secur-Fit6054-1216S6054-1216S2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295518761SMARTSETDEPUY (IRELAND)KWL2026-09-10
10603295518761SMARTSETDEPUY (IRELAND)KWY2026-09-10
00190446153917DJO SURGICALEncore Medical, L.P.LWJ2017-03-30
00190446153917DJO SURGICALEncore Medical, L.P.LZO2017-03-30
00190446153917DJO SURGICALEncore Medical, L.P.KWZ2017-03-30
00190446153924DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153924DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153924DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153931DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153931DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153931DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153948DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153948DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153948DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153955DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153955DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153955DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153962DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153962DJO SURGICALEncore Medical, L.P.LZO2017-03-07
00190446153962DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153979DJO SURGICALEncore Medical, L.P.KWZ2017-03-03
00190446153979DJO SURGICALEncore Medical, L.P.LWJ2017-03-03
00190446153979DJO SURGICALEncore Medical, L.P.LZO2017-03-03
00190446153986DJO SURGICALEncore Medical, L.P.KWZ2017-03-03
00190446153986DJO SURGICALEncore Medical, L.P.LZO2017-03-03
00190446153986DJO SURGICALEncore Medical, L.P.LWJ2017-03-03
00190446153993DJO SURGICALEncore Medical, L.P.LWJ2017-03-03
00190446153993DJO SURGICALEncore Medical, L.P.KWZ2017-03-03
00190446153993DJO SURGICALEncore Medical, L.P.LZO2017-03-03
00190446154006DJO SURGICALEncore Medical, L.P.LWJ2017-03-03