FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523145652
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
A 200
Catalog number
1204-234-514
Device description
R UHMWPE PS PLUS Tibial Insert Sz C 14mm
Published
2019-07-11
Public version status
New
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
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
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190122000Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies2019-06-20JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841523145652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523145652008415231456528415231456520841523145652

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116995646
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841523185610Kyocera Medical Technologies, Inc.Tesera-K XL2173-001-0042026-10-15
00841523183944Kyocera Medical Technologies, Inc.Initia T33535-851-0122026-08-21
00841523183999Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5112026-08-21
00841523184002Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5132026-08-21
00841523184019Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5152026-08-21
00841523184026Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5172026-08-21
00841523184033Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5192026-08-21
00841523184040Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5212026-08-21
00841523185337Kyocera Medical Technologies, Inc.Tesera-K-SC3061-011-0162026-08-21
00841523183081Kyocera Medical Technologies, Inc.Tesera-K XL2173-001-0032026-08-07
00841523183746Kyocera Medical Technologies, Inc.Tesera-K XL3073-005-0002026-08-07
00841523185030Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1082026-08-07
00841523185047Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1102026-08-07
00841523185054Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1122026-08-07
00841523185061Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1142026-08-07
00841523185078Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1162026-08-07
00841523185092Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-2102026-08-07
00841523185108Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-2122026-08-07
00841523185139Kyocera Medical Technologies, Inc.Tesera-K XL2173-022-1082026-08-07
00841523185146Kyocera Medical Technologies, Inc.Tesera-K XL2173-022-1102026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247750Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247750Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247989Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247989Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDOIY2026-10-23