FDA.reportPublic FDA data

Cermet Series III

Primary DI
05051693310889
Brand
Cermet Series III
Company
IMPLANTS INTERNATIONAL LTD
Model
Ceramic Liner 54/56 x 44mm - 36mm Head
Catalog number
AL3931
Device description
Ceramic Liner for Acetabular Shell ( 36mm Head) (Ceramic) 54/56 x 44mm - 36mm
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
K071583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071583000CERMET III ACETABULAR CUP SYSTEMImplants International, Ltd.2007-07-25MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051693310889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051693310889050516933108895051693310889

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic femoral head prosthesisA sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter56Millimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401642769080michael.russon@implantsinterna
+4401642769080michael.russon@implantsinternational.com
+4401642769080mohan.emmanuel@implantsinternational.com
+4401642769080enquiries@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
00843575126801Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126818Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126825Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126832Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126849Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126856Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126863Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126870Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126887Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126894Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126900Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126917Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126924Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126931Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126948Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126955Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126962Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126979Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126986Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128621Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128638Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128645Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128652Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128669Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
07611996142334POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996103410POLARSTEMSmith & Nephew, Inc.MEH2016-07-25