ClearanceBrief
Company · US

Encore Medical, Lp

FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.

85510(k) clearances (4 in 12 months)
189recalls (7 in 12 months)
145recalls that name a 510(k)

Product codes

CodeDeviceRecords
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer59
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented44
PHXShoulder Prosthesis, Reverse Configuration34
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented24
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented18
KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)8
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented7
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive7
JDKProsthesis, Hip, Cement Restrictor6
LKHAntisera, Immunoperoxidase, Chlamydia Spp.6
LXHOrthopedic Manual Surgical Instrument6
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer6
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented6
HWAImpactor5
LODBone Cement5
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer4
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer3
KWQAppliance, Fixation, Spinal Intervertebral Body3
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 2, 2026K263086AltiVate Reverse® Glenosphere with RAVN™ Technology
Encore Medical L.P.
PHX
Jan 15, 2026K252567AltiVate Reverse® ADLC Glenosphere
Encore Medical L.P.
PHX
Dec 19, 2025K252974EMPOWR Knee
Encore Medical L.P.
JWH
Nov 12, 2025K251833EMPOWR Acetabular® Liner Extension
Encore Medical L.P.
LPH
Aug 5, 2025K252141AltiVate Reverse® Glenoid
Encore Medical L.P.
PHX
Jul 8, 2025K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
Encore Medical L.P.
JWH
Jul 2, 2025K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)
Encore Medical L.P.
JWH
May 16, 2025K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System
Encore Medical L.P.
PHX
Feb 7, 2025K241483ceramys™ femoral head system
Encore Medical L.P.
LZO
May 29, 2024K233481AltiVate Reverse® Glenoid
Encore Medical L.P.
PHX
Jun 23, 2023K222592AltiVate® Anatomic Shoulder AG e+™ with Markers
Encore Medical L.P.
KWS
Feb 13, 2023K223779EMPOWR™ blade stem
Encore Medical, LLC
LPH
Jul 7, 2022K213387AltiVate® Anatomic Shoulder AG e+™ with Markers
Encore Medical L.P.
KWS
Apr 1, 2022K213793EMPOWR Revision Knee
Encore Medical L.P.
JWH
Mar 30, 2021K210308EMPOWR Porous Femur with HAnano SurfaceTM
Encore Medical L.P.
MBH
Feb 10, 2021K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
Encore Medical L.P.
LPH
Dec 23, 2020K203026AltiVate® Anatomic Pegged Glenoid with Markers
Encore Medical L.P.
KWS
Jun 3, 2020K193226AltiVate Anatomic Canal-Sparing (CS) Shoulder
Encore Medical L.P.
PKC
Jul 16, 2019K191325EMPOWR Partial Knee
Encore Medical L.P.
HSX
Jun 7, 2019K190057DJO Acetabular System
Encore Medical L.P.
LPH
Apr 26, 2019K190290AltiVate Reverse Humeral Stem, 48mm
Encore Medical L.P.
KWS
Jul 9, 2018K180930EMPOWR VVC TIBIAL INSERT
Encore Medical L.P.
JWH
Mar 5, 2018K173723EMPOWR Universal Tibial Baseplate
Encore Medical L.P.
JWH
Dec 26, 2017K173073AltiVate Anatomic to Reverse Conversion Module
Encore Medical L.P.
PHX
Dec 13, 2017K172651FMP Extended Liners
Encore Medical L.P.
OQG
Oct 30, 2017K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Sm
Encore Medical L.P.
KWS
Oct 4, 2017K171991EMPOWR Porous Knee System
Encore Medical L.P.
MBH
May 31, 2017K170573Empowr CR Knee Tibial Insert
Encore Medical L.P.
JWH
Mar 2, 2017K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Latera
Encore Medical L.P.
KWZ
Nov 21, 2016K162024AltiVate Anatomic Shoulder System
Encore Medical L.P.
KWS
Nov 9, 2016K161610EXPRT Revision Hip System
Encore Medical L.P.
KWZ
Sep 23, 2016K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)
Encore Medical L.P.
JWH
May 19, 2016K160342EMPOWR PS Knee System
Encore Medical L.P.
JWH
May 15, 2015K143242Rebel 3DKNEE System
Encore Medical L.P.
JWH
Nov 7, 2014K141990ENCORE HUMERAL SHOULDER STEM
Encore Medical L.P.
PHX
Nov 6, 2014K140130X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED
Encore Medical L.P.
OQG
Jul 11, 2014K140830EXPRT REVISION KNEE
Encore Medical L.P.
JWH
May 6, 2014K140904RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
Encore Medical L.P.
PHX
Mar 24, 2014K130550RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
Encore Medical L.P.
PHX
Oct 29, 2013K130048REVERSE SHOULDER PROSTHESIS MONOBLOCK
Encore Medical L.P.
KWS
Sep 23, 2013K130365X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
Encore Medical L.P.
OQG
Jun 21, 2013K130099TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
Encore Medical L.P.
LPH
Apr 11, 2013K122239FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING
Encore Medical L.P.
JWH
Jan 23, 2013K123982TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
Encore Medical L.P.
KWS
Nov 2, 2012K122636REVELATION POROUS COATED HIP STEM, SIZE 8
Encore Medical L.P.
LPH
Aug 15, 2012K121727MOVATION KNEE SYSTEM
Encore Medical L.P.
OIY
Jul 20, 2012K121835DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE
Encore Medical L.P.
JWH
Jun 19, 2012K121024LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8;
Encore Medical L.P.
LPH
Mar 14, 2012K113756HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA
Encore Medical L.P.
OIY
Feb 24, 2012K120241LINEAR HIP STEM, SIZE 5
Encore Medical L.P.
LPH

Newest 50 of 85.

Latest recalls

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: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
Open, Classified		 JWHK143242
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		 JWHK143242
Feb 24, 2026Encore Medical, LP
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Open, Classified		 PHXK051075
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		 JWHK143242
Feb 24, 2026Encore Medical, LP
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Open, Classified		 KWSK100741
Feb 2, 2026Encore Medical, LP
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degr
Open, Classified		 LPHK190057
Feb 2, 2026Encore Medical, LP
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Open, Classified		 JWHK143242
Sep 10, 2025Encore Medical, LP
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of pa
Open, Classified		 FSMK233481
Sep 10, 2025Encore Medical, LP
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
Open, Classified		 KWSK233481
Sep 10, 2025Encore Medical, LP
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
Open, Classified		 KWSK233481
Sep 10, 2025Encore Medical, LP
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
Open, Classified		 KWSK233481
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		 JWHK143242
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		 JWHK143242
Jul 21, 2025Encore Medical, LP
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mo
Open, Classified		 LPHK203557
Jul 21, 2025Encore Medical, LP
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mo
Open, Classified		 LPHK203557
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		 JWHK143242
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		 JWHK143242
Jun 23, 2025Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices
Open, Classified		 PHXK233481
Jun 23, 2025Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices
Open, Classified		 PHXK233481
Jun 23, 2025Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices
Open, Classified		 PHXK233481
Jun 23, 2025Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices
Open, Classified		 PHXK233481
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		 JWHK143242
Dec 23, 2024Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Open, Classified		 JWHK143242
Jan 2, 2024Encore Medical, LP
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Completed		 PHXK113756
Jan 2, 2024Encore Medical, LP
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Completed		 PHXK051075
Dec 12, 2023Encore Medical, LP
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Open, Classified		 PHXK112069
Dec 7, 2023Encore Medical, LP
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of
Open, Classified		 MBHK171991
Nov 8, 2023Encore Medical, LP
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Open, Classified		 PHXK051075
Nov 8, 2023Encore Medical, LP
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Open, Classified		 KWSK172351
Nov 7, 2023Encore Medical, LP
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Open, Classified		 MBHK171991
Oct 12, 2023Encore Medical, LP
EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H
Open, Classified		 LPHK190057
Oct 12, 2023Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Open, Classified		 JWHK143242
Oct 12, 2023Encore Medical, LP
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Open, Classified		 PHXK041066
Sep 19, 2023Encore Medical, LP
DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
Open, Classified		 KWSK172351
Sep 19, 2023Encore Medical, LP
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Ne
Open, Classified		 PHXK051075
Sep 19, 2023Encore Medical, LP
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
Open, Classified		 KWAK052320
Sep 19, 2023Encore Medical, LP
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Open, Classified		 LZOK082844
Sep 19, 2023Encore Medical, LP
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Open, Classified		 JWHK173723
Apr 12, 2023Encore Medical, LP
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Open, Classified		 MBHK212941
Feb 27, 2023Encore Medical, LP
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNE
Open, Classified		 JWHK180930
Oct 21, 2022Encore Medical, LP
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Open, Classified		 LPHK143242
Oct 21, 2022Encore Medical, LP
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Open, Classified		 LPHK190057
May 5, 2022Encore Medical, LP
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Open, Classified		 JWHK143242
Jun 28, 2021Encore Medical, LP
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
Open, Classified		 KWSK162024
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		 JWHK143242
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		 JWHK143242
Feb 5, 2021Encore Medical, LP
DJO EMPOWR KNEE Femoral Sizer
Open, Classified		 JWHK143242
Oct 7, 2020Encore Medical, LP
DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of
Open, Classified		 MBHK171991
Sep 9, 2020Encore Medical, LP
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatm
Open, Classified		 LPHK190057
Aug 31, 2020Encore Medical, LP
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are can
Terminated		 KWSK172351

Newest 50 of 189.

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