FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446879718
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
356-01-003
Device description
EMP Rev Knee, Symmetric TT Cone, Tibial, MD
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251241000EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.2025-07-02JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446879718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446879718001904468797181904468797180190446879718

GMDN Terms#

Term, Definition table
TermDefinition
Knee arthroplasty wedgeAn implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446153818DJO SURGICAL495-00-0652017-02-28
00190446153825DJO SURGICAL495-00-0752017-02-28
00190446153832DJO SURGICAL495-00-0852017-02-28
00190446153849DJO SURGICAL495-01-0652017-02-28
00190446153856DJO SURGICAL495-01-0752017-02-28
00190446153863DJO SURGICAL495-01-0852017-02-28
00190446153917DJO SURGICAL495-14-1302017-03-30
00190446153924DJO SURGICAL495-14-1702017-03-07
00190446153931DJO SURGICAL495-14-2102017-03-07
00190446153948DJO SURGICAL495-15-1302017-03-07
00190446153955DJO SURGICAL495-15-1702017-03-07
00190446153962DJO SURGICAL495-15-2102017-03-07
00190446153979DJO SURGICAL495-16-1302017-03-03
00190446153986DJO SURGICAL495-16-1702017-03-03
00190446153993DJO SURGICAL495-16-2102017-03-03
00190446154006DJO SURGICAL495-17-1302017-03-03
00190446154013DJO SURGICAL495-17-1702017-03-03
00190446154020DJO SURGICAL495-17-2102017-03-03
00190446154037DJO SURGICAL495-18-1302017-03-03
00190446154044DJO SURGICAL495-18-1702017-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05056139248597Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249013Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249020Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249037Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249044Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249303Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249310Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249327Unity Total Knee SystemCORIN LTDJWH2026-10-23