SLK Evo

Primary DI
05051693400252
Brand
SLK Evo
Company
IMPLANTS INTERNATIONAL LTD
Model
CS Femoral (PS) Left 55mm
Catalog number
KS5984
Device description
Cruciate Sacrificing (Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt Chrome), Denoted size 55mm (Width) Anatomical Orientation - Left
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980999000ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTInstrument Makar, Inc.1998-11-06JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051693400252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051693400252050516934002525051693400252

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-stabilized total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative joint [total knee arthroplasty (TKA)] or for prosthesis revision; it is implanted when the posterior cruciate ligament is sacrificed and uses a “cam and post†mechanism to replace the stabilizing function of the ligament. It includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implanted with or without bone cement and is often used in cases where bone stock and mediolateral stability are good in the face of severe deformities or ligament degeneration.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width55Millimeter

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
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29
03701089517515TRAXAMPLITUDE SASJWH2026-07-29
03701089517522TRAXAMPLITUDE SASJWH2026-07-29
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03701089517584TRAXAMPLITUDE SASJWH2026-07-29
03701089517591TRAXAMPLITUDE SASJWH2026-07-29
03701089517607TRAXAMPLITUDE SASJWH2026-07-29
03701089517614TRAXAMPLITUDE SASJWH2026-07-29
03701089517621TRAXAMPLITUDE SASJWH2026-07-29
03701089517638TRAXAMPLITUDE SASJWH2026-07-29
03701089517645TRAXAMPLITUDE SASJWH2026-07-29
03701089517652TRAXAMPLITUDE SASJWH2026-07-29
03701089517669TRAXAMPLITUDE SASJWH2026-07-29
03701089518390TRAXAMPLITUDE SASJWH2026-07-29
03701089518406TRAXAMPLITUDE SASJWH2026-07-29
03701089518413TRAXAMPLITUDE SASJWH2026-07-29
03701089518420TRAXAMPLITUDE SASJWH2026-07-29
03701089518437TRAXAMPLITUDE SASJWH2026-07-29
03701089518444TRAXAMPLITUDE SASJWH2026-07-29