FDA.reportPublic FDA data

P.C.A.

Primary DI
07613154056040
Brand
P.C.A.
Company
Howmedica Osteonics Corp.
Model
2642-5-122
Catalog number
2642-5-122
Device description
Primary Insert
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K972863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972863000DURATION STABILIZED UHMWPE KNEE COMPONENTSHowmedica Corp.1997-10-29JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613154056040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154056040076131540560407613154056040

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
07613327128420Simplex6197-9-0016197-9-0012017-06-19
07613327128437Simplex6188-1-0016188-1-0012015-09-24
07613327128444Simplex6191-1-0016191-1-0012015-09-24
07613327128451Simplex6192-1-0016192-1-0012017-06-19
07613327181531INSTRUMENT0901-1-0000901-1-0002016-09-24
07613327020786Secur-Fit6054-0509S6054-0509S2015-09-24
07613327020793Secur-Fit6054-0511S6054-0511S2015-09-24
07613327020809Secur-Fit6054-0610S6054-0610S2015-09-24
07613327020816Secur-Fit6054-0612S6054-0612S2015-09-24
07613327020823Secur-Fit6054-0812S6054-0812S2015-09-24
07613327020830Secur-Fit6054-0713S6054-0713S2015-09-24
07613327020847Secur-Fit6054-0711S6054-0711S2015-09-24
07613327020854Secur-Fit6054-0814S6054-0814S2015-09-24
07613327020861Secur-Fit6054-0913S6054-0913S2015-09-24
07613327020878Secur-Fit6054-1014S6054-1014S2015-09-24
07613327020885Secur-Fit6054-1016S6054-1016S2015-09-24
07613327020892Secur-Fit6054-0915S6054-0915S2015-09-24
07613327020908Secur-Fit6054-1115S6054-1115S2015-09-24
07613327020915Secur-Fit6054-1117S6054-1117S2015-09-24
07613327020922Secur-Fit6054-1216S6054-1216S2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056886089InterSpace® Knee Mold Femoral Component XSOSARTIS GmbHJWH2026-10-29
04260056886102InterSpace® Knee Mold Femoral Component SOSARTIS GmbHJWH2026-10-29
04260056886126InterSpace® Knee Mold Femoral Component MOSARTIS GmbHJWH2026-10-29
04260056886140InterSpace® Knee Mold Femoral Component LOSARTIS GmbHJWH2026-10-29
04260056886164InterSpace® Knee Mold Femoral Component XLOSARTIS GmbHJWH2026-10-29
04260056886188InterSpace® Knee Mold Tibial Component XSOSARTIS GmbHJWH2026-10-29
04260056886201InterSpace® Knee Mold Tibial Component SOSARTIS GmbHJWH2026-10-29
04260056886263InterSpace® Knee Mold Tibial Component XLOSARTIS GmbHJWH2026-10-29
04260056886225InterSpace® Knee Mold Tibial Component MOSARTIS GmbHJWH2026-10-28
04260056886249InterSpace® Knee Mold Tibial Component LOSARTIS GmbHJWH2026-10-28
05056139247750Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247989Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248146Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248153Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248160Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248177Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248184Unity Total Knee SystemCORIN LTDJWH2026-10-23