FDA.reportPublic FDA data

Stability

Primary DI
05051693300736
Brand
Stability
Company
IMPLANTS INTERNATIONAL LTD
Model
Flanged Uncemented Hip Stem - Size 5
Catalog number
HS1316
Device description
Flanged Uncemented Hip Stem - Size 5 - 170mm long (Cobalt Chrome) 12/14 Taper
Published
2016-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922613000CL HIP STEM H/A COATEDLima Intl. Corp.1994-04-05MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051693300736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051693300736050516933007365051693300736

GMDN Terms#

Term, Definition table
TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined 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
Length170Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room temperature and Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401642769080michael.russon@implantsinterna
+4401642769080michael.russon@implantsinternational.com
+4401642769080enquiries@implantsinternational.com
+4401642769080mohan.emmanuel@implantsinternational.com

Regulatory Flags#

DUNS number
346627222
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051693300330PerformaCollared Hip Stem - Size 1 (139 x 9mm)HS12042016-07-31
05051693300347PerformaCollared Hip Stem - Size 2 (142 x 10mm)HS12052016-07-31
05051693300354PerformaCollared Hip Stem - Size 3 (146 x 11mm)HS12062016-07-31
05051693300361PerformaCollared Hip Stem - Size 4 (149 x 12mm)HS12072016-07-31
05051693300378PerformaCollared Hip Stem - Size 5 (153 x 13mm)HS12082016-07-31
05051693300385PerformaCollared Hip Stem - Size 6 (156 x 14mm)HS12092016-07-31
05051693300392PerformaCollared Hip Stem - Size 7 (160 x 15mm)HS12102016-07-31
05051693300408PerformaCollared Hip Stem - Size 8 (163 x 16mm)HS12112016-07-31
05051693300415PerformaCollared Hip Stem - Size 3-1 (165 x 11mm) LONGHS12902016-07-31
05051693300422PerformaCollared Hip Stem - Size 4 (165 x 12mm) LONGHS12912016-07-31
05051693300439PerformaCollared Hip Stem - Size 5 (165 x 13mm) LONGHS12922016-07-31
05051693300446PerformaCollared Hip Stem - Size 6 (165 x 14mm) LONGHS12932016-07-31
05051693300576StabilityFlanged Cemented Hip Stem - Size 1HS12202016-07-31
05051693300583StabilityFlanged Cemented Hip Stem - Size 2HS12212016-07-31
05051693300590StabilityFlanged Cemented Hip Stem - Size 3HS12222016-07-31
05051693300606StabilityFlanged Cemented Hip Stem - Size 4HS12232016-07-31
05051693300613StabilityFlanged Cemented Hip Stem - Size 5HS12242016-07-31
05051693300620StabilityFlanged Cemented Hip Stem - Size 6HS12252016-07-31
05051693300637StabilityStandard Cemented Hip Stem - Size 1HS12262016-07-31
05051693300644StabilityStandard Cemented Hip Stem - Size 2HS12272016-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899177United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899184United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899191United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899207United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899214United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899221United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899238United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899245United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899252United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886910896United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913361Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913378Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913385Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913392Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913408Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15