FDA.reportPublic FDA data

ATTUNE

Primary DI
10603295541394
Brand
ATTUNE
Company
DEPUY (IRELAND)
Model
1518-20-116
Catalog number
151820116
Device description
ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED LEFT AOX 1, 16mm
Published
2021-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211609000
K253197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211609000ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC2021-08-25JWH
K253197000ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC2025-11-19JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295541394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329554139410603295541394

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27
10603295541387ATTUNE1518-20-1141518201142021-08-27
10603295541400ATTUNE1518-20-2051518202052021-08-27
10603295541417ATTUNE1518-20-2061518202062021-08-27
10603295541424ATTUNE1518-20-2071518202072021-08-27
10603295541431ATTUNE1518-20-2081518202082021-08-27
10603295541448ATTUNE1518-20-2101518202102021-08-27
10603295541455ATTUNE1518-20-2121518202122021-08-27
10603295541462ATTUNE1518-20-2141518202142021-08-27
10603295541479ATTUNE1518-20-2161518202162021-08-27
10603295541486ATTUNE1518-20-3051518203052021-08-27
10603295541493ATTUNE1518-20-3061518203062021-08-27
10603295541509ATTUNE1518-20-3071518203072021-08-27
10603295541516ATTUNE1518-20-3081518203082021-08-27
10603295541523ATTUNE1518-20-3101518203102021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247712Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247712Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247743Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247743Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247781Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247781Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247798Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247798Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247903Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247903Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247910Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247910Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247927Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247927Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247996Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247996Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248009Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248009Unity Total Knee SystemCORIN LTDJWH2026-10-19