BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENCORE MEDICAL, L.P.

    Reg #: 1644408 · FEI: 1000116912 · Expires 2026
    View on FDA
    Products
    69
    Proprietary Names
    216
    Establishment Types
    4
    Classifications
    69

    Registration Details

    Registration Name
    ENCORE MEDICAL, L.P.
    Registration Number
    1644408
    FEI Number
    1000116912
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9800 METRIC BLVD.
    City
    AUSTIN
    State
    TX
    ZIP
    78758
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240324
    PMA Number
    H980002

    Owner / Operator

    Firm Name
    ENCORE MEDICAL, L.P.
    Operator Number
    9002203
    Address
    9800 METRIC BLVD., --
    City
    Austin
    State
    TX
    Postal Code
    78758
    Country
    US
    Correspondent
    Sherri - Mellingen

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Semi-Constrained Metal/Polymer Finger Joint Prosthesis MPK
    Guide, Surgical, Instrument FZX
    Rasp HTR
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Hammer, Surgical FZY
    Rod, Fixation, Intramedullary And Accessories HSB
    Orthopedic Manual Surgical Instrument LXH
    Shoulder Prosthesis, Reverse Configuration PHX
    Rongeur HTX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Awl HWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Bone Cement LOD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Reamer HTO
    Prosthesis, Ankle, Uncemented, Non-Constrained NTG
    Driver, Prosthesis HWR
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Dispenser, Cement KIH
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Template HWT
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Elbow, Constrained, Cemented JDC
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Instrument, Surgical, Non-Powered HAO
    Caliper KTZ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Screwdriver HXX
    Forceps HTD
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    File, Surgical, General & Plastic Surgery GEO
    Screw, Fixation, Bone HWC
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Bone Cement, Antibiotic MBB
    Broach HTQ
    Tray, Surgical, Instrument FSM
    Instrument, Cutting, Orthopedic HTZ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented MRA
    Chisel, Bone, Surgical EML
    Chisel, Surgical, Manual FZO
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Bit, Drill HTW
    System, Image Processing, Radiological LLZ
    Orthopedic Stereotaxic Instrument OLO
    Automated Radiological Image Processing Software QIH
    Wrench HXC
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Extractor HWB
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Gauge, Depth HTJ
    Burr, Orthopedic HTT
    Tap, Bone HWX
    Punch, Surgical LRY
    Impactor HWA
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    File HTP
    Osteotome HWM
    Retractor GAD

    Proprietary Names

    EMPOWR Revision Symmetric Knee Cones EPIK - Unicondylar Knee EXPRT 5mm Femoral Augment, 400 Stem Extension EXPRT™ Revision Hip System R120 PC Hip Stem Lima Modular Revision Stem SR PIP Revelation Hip Stems with P2 Linear Hip Stems with P2 LSF FEMORAL NECK CUTTING GUIDE Rasp Foundation Total Shoulder System EMPOWR™ Blade Stem Hammer Foundation Ultra-Congruent TrueFix Manual Surgical Instrument Distractor Reverse Shoulder Prosthesis ENCORE RONGEURS Revelation microMAX Hemi Shoulder Prosthesis Awl CLP III Z-SERIES MODULAR HIP AltiVate Conversion Module Cemented Calcar Hip System Cobalt G-HV Bone Cement Cobalt HV Bone Cement Turon Revision Glenoid ORTHOPEDIC REAMER 3DKNEE PC Femoral Component FMP Acetabulatr Shells with 3DMatrix Foundation Porous Stem Size 8 Porous Patella ceramys™ femoral head system Turon Primary and Revision System AltiVate Reverse Short Stem Bipolar Hip Delta Femoral Heads & Offset Sleeve STAR Scandinavian Total Ankle Replacement Prosthesis TRUE/FLEX & TRUE/FIT INSTU FOUNDATION & VITALITY HIP & SHOULDE MULTIPLE (PROSTHESIS IMPACTOR) Foundation Plasma Metalbacked Patel Foundation Fracture Hip Stem EXPRT Revision Hip OPTIGUN AltiVate CS Edge Shoulder LSF FEMORAL TEMPLATE ENCORE TEMPLATE Linear Plasma Sprayed Hip Stem Foundation Distal Centralizer Discovery Elbow EMPOWR Acetabular® Liner Extension Foundation Augmentation Blocks ALTIVATE REVERSE GLENOID ANGLED REAMER AltiVate Reverse Wedge Glenoid Reamer Sleeve AltiVate Reverse Wedge Glenoid Reamer Boss Drill AltiVate Reverse Glenoid Peripheral Drill Guide AltiVate Reverse Wedge Glenoid Reamer Head AltiVate Reverse Glenoid Peripheral Drill/Screw Guide Replacement Thumbscrew AltiVate Reverse Glenoid Hood Rasp AltiVate Reverse Glenoid Hood Rasp Guide AltiVate Reverse® Glenoid AltiVate Reverse Glenoid Baseplate Rim Planer AltiVate Reverse Glenoid Cannulated Boss Drill AltiVate Reverse Glenoid Baseplate Inserter AltiVate Reverse Cannulated Glenoid Reamer Cobalt MV Bone Cement ENCORE IMPLANT SYST EMPOWR Stem Extender, 50mm DJO Surgical / Encore Medical Powered Instrument Foundation Metal Backed Patella ENCORE SCREWDRIVER UNIVERSAL JOINT SCREWDRIVER Forceps Reverse Shoulder Prosthesis (RSP) Foundation Lateral Pivot Insert Compression Hip/Supracondylar Screw Turon e+ Glenoid Exprt Knee System CLP Hip System Foundation PS Knee Surgical File/Planer/Rasp Foundation Glenoid Component RSP e+ Liner 3DKnee e+ Tibial Inserts AltiVate® Anatomic Shoulder AG e+™ with Markers All Poly Tri Peg Sombrero Patella MTS Knee Encore Humeral Shoulder Stem 6.5 Cancellous Bone Screw Foundation Plasma Sprayed Femoral EMPOWR Porous Knee System Revelation Hip Stem, Sz 8 Metal/Metal Hip System Movation Knee System Cobalt G-MV Bone Cement LSF BROACH DJO Surgical Instrument Tray AltiVate® Anatomic Shoulder AG e+™ with Markers (FW) 3DKNEE System AltiVate Reverse Small Shell System Keramos Ceramic-on-Ceramic Hip System FMP/Foundation Porous Hemispherical SR MCP CLP Hip Stem FEMORAL CUTTING CHISEL ENCORE CHISEL Foundation Porous Hip Stem EMPOWR Universal Tibial Baseplate CLP Offset Hip System Foundation Unipolar Chisel Foundation Forged Cemented Stem 9mm Foundation Porous Stem w/Metal Head EMPOWR Partial Knee FMP Porous Coated Flared Rim Shells FMP e+ Acetabular Liner FOUNDATION AND VITALITY HIP KNEE AND SHOULDER INSTRUMENT SYSTEMS , TRUE IX FMP Acetabular Shells with P2 Foundation Plasma Tibial Component Foundation Non-Porous Stem EMPOWR VVC Insert ARVIS® Shoulder DJO Surgical / Encore Medical Wrench EMPOWR Dual Mobility RSP Size 44 Heads RSP Size 44 Socket Shells Foundation HA Coated Stems Linear HA Coated Stems Revelation HA Coated Stems RSP Monoblock 8mm Spacer SHOULDER INSTRUMENTATION TRUE/FLEX , HIP FOUNDATION KNEE IX INSTRUMENAN & TRUE TaperFill Hip Stem EMPOWR Acetabular System Foundation Humeral Stem EMPOWR PS Knee System TrueFix Distal Femoral Intramedullary Rod System True/Fix Large Screw Depth Gauge X-alt Hip System FMP Shells Large CoCr Heads R120 Hip Stem HIP ITALITY HIP INSTRUMENTS SYSTEM ,SHOULDER INSTRUMENT SYSTEMS Revelation Size 8 Hip Stem with P2 Foundation and 3DKnee All Poly Patella (standard poly and e+) RSP to Foundation Humeral Stem Adapter RSP Monoblock Press Fit Indication FMP/Foundation Porous Acetabular Spiked Bone Tap Linear Hip Stem, sz 5 DJO Surgical / Encore Medical Surgical Punch Alfa II Hip Stem Modular Femoral Neck RSP Baseplate with P2 True/Fix Humeral Intramedullary Rod Empowr CR Knee™ Tibial Insert RSP Monoblock to Turon Conversion Adapter EMPOWR 3DKNEE ENCORE IMPACTORS Revelation Hip Stem RSP Monoblock RSP Size 44 Offset Insert RSP Size 44 Constrained Liner ENCORE SAW BLADES RSP Monoblock Fracture Indication File AltiVate™ Anatomic Shoulder System Movation e+ Tri Peg Domed Patella Foundation e+ Tri Peg Sombrero Patella 3DKnee e+ Tri Peg Sombrero Patella Foundation All-Poly Cup Foundation Modular Hip Stem Foundation Modular Stem Extensions Linear Hip Stem with P2, Size 5 Foundation All-Poly Cup w/PMMA Spac Foundation Modular Tibial Baseplate FMP Extended Liner Z-SERIES MODULAR TOTAL HIP SYSTEM EMPOWR Revision Knee™ Foundation Plasma Sprayed Shoulder Lima Acetabular Cage Foundation NP Femur Linear Hip Stem EMPOWR Porous Femur with HAnano Surface FMP Metal/Metal Acetabular Insert Foundation Knee, Foundation PS Knee, 3DKnee with TiNbN Coating Osteotome True/Fix Bone Screws RSP Monoblock Hemi Adapter Foundation Zirconia Heads ARVIS Surgical Navigation System Foundation Porous Stems Biolox Forte Ceramic Heads Movation e+ Tibial Insert Foundation Cemented Stem, Size 8 HXe-Plus Acetabular Liner FMP Constrained Liners EMPOWR Revision Knee™ Symmetric TT Cones Omega HA Total Hip System ALFA Hip Stem

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)