FDA.reportPublic FDA data

MRS

Primary DI
07613327048261
Brand
MRS
Company
Howmedica Osteonics Corp.
Model
6485-2-611
Catalog number
6485-2-611
Device description
Pediatric All Poly Tibia
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
LGEPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2
LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-BearingOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223069000
K992346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223069000Modular Rotating Hinge Knee Systems and Compatible ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023-04-21KRO
K992346000KINEMATIC II ROTATING HINGE KNEEHowmedica Osteonics Corp.1999-08-12LGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327048261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327048261076133270482617613327048261

GMDN Terms#

Term, Definition table
TermDefinition
Rotating hinged total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
07613327036503Triathlon5585-C-0165585-C-0162015-09-24
07613327036510Triathlon5585-C-0205585-C-0202015-09-24
07613327036527Triathlon5585-C-0255585-C-0252015-09-24
07613327036534Triathlon5585-C-0305585-C-0302015-09-24
07613327036541Triathlon5585-C-0355585-C-0352015-09-24
07613327036558Triathlon5585-C-0405585-C-0402015-09-24
07613327036565Triathlon5585-C-0455585-C-0452015-09-24
07613327036572Triathlon5585-C-0505585-C-0502015-09-24
07613327036589Triathlon5585-C-0555585-C-0552015-09-24
07613327036596Triathlon5585-C-0605585-C-0602015-09-24
07613327041071Triathlon5520-M-1005520-M-1002015-09-24
07613327041095Triathlon5520-M-2005520-M-2002015-09-24
07613327041101Triathlon5520-M-3005520-M-3002015-09-24
07613327041118Triathlon5520-M-4005520-M-4002015-09-24
07613327041125Triathlon5520-M-5005520-M-5002015-09-24
07613327041132Triathlon5520-M-6005520-M-6002015-09-24
07613327041149Triathlon5520-M-7005520-M-7002015-09-24
07613327041156Triathlon5520-M-8005520-M-8002015-09-24
07613327041392Triathlon5527-B-1005527-B-1002015-09-24
07613327041408Triathlon5527-B-3005527-B-3002015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295529712ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529729ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529736ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529743ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529750ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529767ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529774ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529781ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529798ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529804ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529811ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529828ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529835ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529842ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529859ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529866ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529873ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529880ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529897ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529903ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529910ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529927ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529934ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529941ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529958ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529965ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529972ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529989ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529996ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295530008ATTUNEDEPUY (IRELAND)KRO2025-10-31