ClearanceBrief
510(k) K143242 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Rebel 3DKNEE System

ApplicantEncore Medical L.P., Austin TX, US
DecisionSubstantially Equivalent, May 15, 2015
ReceivedNov 12, 2014
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K143242

DateFirm and productCodeLinked 510(k)
Jul 8, 2026Encore Medical, LP
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
Open, Classified		 JWHNone listed
Jul 8, 2026Encore Medical, LP
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
Open, Classified		 JWHNone listed
Feb 24, 2026Encore Medical, LP
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Open, Classified		 JWHNone listed
Feb 2, 2026Encore Medical, LP
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Open, Classified		 JWHNone listed
Aug 8, 2025Encore Medical, LP
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment o
Open, Classified		 JWHNone listed
Aug 8, 2025Encore Medical, LP
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment o
Open, Classified		 JWHNone listed
Jul 17, 2025Encore Medical, LP
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are i
Open, Classified		 JWHNone listed
Jul 17, 2025Encore Medical, LP
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are i
Open, Classified		 JWHNone listed
Dec 26, 2024Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Open, Classified		 JWHNone listed
Dec 23, 2024Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Open, Classified		 JWHNone listed
Oct 12, 2023Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Open, Classified		 JWHNone listed
Oct 21, 2022Encore Medical, LP
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Open, Classified		 LPHNone listed
May 5, 2022Encore Medical, LP
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Open, Classified		 JWHNone listed
May 12, 2021Encore Medical, LP
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Open, Classified		 JWHNone listed
May 12, 2021Encore Medical, LP
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Open, Classified		 JWHNone listed
Feb 5, 2021Encore Medical, LP
DJO EMPOWR KNEE Femoral Sizer
Open, Classified		 JWHNone listed
Nov 15, 2016Encore Medical, Lp
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Terminated		 JWHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.