EMPOWR Acetabular® Liner Extension
Encore Medical L.P.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1644408 | 1000116912 | ENCORE MEDICAL, L.P. | 1 | Y | 2026-01-01 | 9800 METRIC BLVD. AUSTIN TX US 78758 |
| 3043011229 | 3043011229 | ENCORE MEDICAL, L.P. | 1 | Y | 2026-01-01 | 2203 Scottsdale Drive Cedar Park TX US 78641 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 43474 | 1559720354 | P050050 | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) | NTG | 2009-05-27 |
| 43474 | 1995472629 | N980003 | KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM | MRA | 2003-11-26 |
| 43474 | 2021873452 | K994070 | REVELATION POROUS HIP STEM | LPH | 2000-01-20 |
| 43474 | 1449691427 | K993943 | ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA | MEH | 2000-02-04 |
| 43474 | 1369071990 | K991603 | GRIT BLASTED HUMERAL STEM | KWT | 1999-06-29 |
| 43474 | 1342961693 | K991325 | MODIFICATION OF ENCORE LINEAR POROUS COATED HIP | LPH | 1999-06-25 |
| 43474 | 1358583920 | K991227 | 8MM FORGED CEMENTED STEM | JDI | 1999-06-01 |
| 43474 | 1921955687 | K991226 | FOUNDATION POROUS HIP STEM | LZO | 1999-06-01 |
| 43474 | 1059874930 | K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | HSB | 1998-06-01 |
| 43474 | 1497298387 | K980981 | OMEGA HA COATED TOTAL HIP SYSTEM | LPH | 1998-05-20 |
| 43474 | 1343356416 | K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM | HSB | 1998-04-03 |
| 43474 | 1416678102 | K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS | HWC | 1998-03-12 |
| 43474 | 1438415379 | K974294 | ENCORE LINEAR POROUS COATED HIP | LPH | 1998-01-12 |
| 43474 | 1054130973 | K974095 | FOUNDATION POROUS COATED FLARED RIM SHELL | LPH | 1998-01-28 |
| 43474 | 2047490217 | K974093 | FOUNDATION POROUS COATED HEMISPHERICAL SHELL | LPH | 1998-01-28 |
| 43474 | 1046638153 | K973809 | FOUNDATION FRACTURE STEM | JDI | 1998-01-02 |
| 43474 | 1806866249 | K973685 | REVELATION POROUS HIP STEM | LPH | 1997-12-19 |
| 43474 | 1196419098 | K973672 | FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA | JWH | 1997-12-18 |
| 43474 | 1249522478 | K973614 | FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES | KWL | 1997-12-18 |
| 43474 | 1873031276 | K973302 | FOUNDATION POROUS HIP STEM | LPH | 1997-12-02 |
| 43474 | 1854866098 | K973119 | FOUNDATION POROUS ACETABULAR SYSTEM | LPH | 1998-01-28 |
| 43474 | 1937806731 | K972791 | ENCORE LINEAR HIP | JDI | 1998-01-12 |
| 43474 | 1017873823 | K972403 | BTI CORTICAL BONE SCREWS | HWC | 1997-08-29 |
| 43474 | 1594360010 | K970031 | FOUNDATION KNEE SYSTEM TIBIAL COMPONENT | JWH | 1997-04-02 |
| 43474 | 1468697292 | K965002 | ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND | LZO | 1997-06-27 |
| 43474 | 1015536859 | K964008 | FOUNDATION KNEE SYSTEM | JWH | 1996-12-27 |
| 43474 | 1086598185 | K963028 | TIBIAL INSERT | JWH | 1996-10-01 |
| 43474 | 2056055607 | K962846 | EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM | LXT | 1996-10-23 |
| 43474 | 1241989142 | K962552 | EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM | HSB | 1996-09-25 |
| 43474 | 1396198416 | K961890 | FOUNDATION 9MM FORGED CEMENTED STEM | JDI | 1996-06-14 |
| 43474 | 1324281640 | K960906 | FOUNDATION GLENOID COMPONENT | KWS | 1996-04-15 |
| 43474 | 1330382465 | K955563 | FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS | LPH | 1996-08-09 |
| 43474 | 1987899880 | K953510 | HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS | KWY | 1995-08-09 |
| 43474 | 1059667048 | K952191 | FORGED CEMENTED STEM | JDI | 1995-07-17 |
| 43474 | 1483441860 | K950651 | TOTAL SHOULDER PROSTHESIS | KWS | 1995-05-30 |
| 43474 | 1484688818 | K950594 | HEMI-SHOULDER PROSTHESIS | HSD | 1995-05-22 |
| 43474 | 1612357457 | K942611 | FOUNDATION ALL POLY CUP | JDI | 1994-09-28 |
| 43474 | 1457071469 | K941306 | FOUNDATION KNEE AUGMENTATION BLOCKS | JWH | 1995-02-08 |
| 43474 | 1858655275 | K935449 | FOUNDATION NON-POROUS STEM | JDI | 1995-03-30 |
| 43474 | 1855051624 | K935263 | FOUNDATION POROUS STEM | JDI | 1995-07-11 |
| 43474 | 1617595413 | K934169 | FOUNDATION ALL POLY CUP | JDI | 1994-05-03 |
| 43474 | 1378070002 | K933539 | FOUNDATION POSTERIOR STABILIZED KNEE | JWH | 1994-11-08 |
| 43474 | 1825709183 | K932481 | SL-PLUS AND SLR-PLUS | JDI | 1994-06-08 |
| 43474 | 1179494694 | K932425 | FOUNDATION MODULAR TIBIAL BASEPLATE | JWH | 1994-07-22 |
| 43474 | 1270504161 | K932246 | FOUNDATION METAL-BACKED PATELLA | JWH | 1994-07-22 |
| 43474 | 1752505434 | K931665 | 6.5 MM CANCELLOUS BONE SCREW | HWC | 1994-02-17 |
| 43474 | 1424205143 | K930963 | SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS | LZO | 1994-01-07 |
| 43474 | 1783879256 | K923277 | FOUNDATION KNEE SYSTEM | JWH | 1993-02-09 |
| 43474 | 1630317377 | K910010 | Q SYSTEM 28 HIP STEM | LWJ | 1991-03-12 |
| 43474 | 1741763665 | K905613 | MTS KNEE SYSTEM | JWH | 1991-06-24 |
| 43474 | 1225204156 | K251833 | EMPOWR Acetabular® Liner Extension | LPH | 2025-11-12 |
| 43474 | 1475656484 | K251241 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) | JWH | 2025-07-02 |
| 43474 | 1415008429 | K241483 | ceramys™ femoral head system | LZO | 2025-02-07 |
| 43474 | 1137105139 | K240324 | EMPOWR Revision Symmetric Knee Cones | JWH | 2024-04-26 |
| 43474 | 1529766818 | K233481 | AltiVate Reverse® Glenoid | PHX | 2024-05-29 |
| 43474 | 1595452613 | K230441 | EMPOWR Stem Extender, 50mm | JWH | 2023-03-17 |
| 43474 | 1301729811 | K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | JWH | 2023-04-06 |
| 43474 | 1569645581 | K223779 | EMPOWR™ blade stem | LPH | 2023-02-13 |
| 43474 | 1223177523 | K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | KWS | 2023-06-23 |
| 43474 | 1753477236 | K213793 | EMPOWR Revision Knee | JWH | 2022-04-01 |
| 43474 | 1534117996 | K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | KWS | 2022-07-07 |
| 43474 | 1294433554 | K212941 | Porous Patella | MBH | 2022-01-20 |
| 43474 | 1680945218 | K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | MBH | 2021-03-30 |
| 43474 | 1810022781 | K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing | LPH | 2021-02-10 |
| 43474 | 1141455945 | K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | PKC | 2020-06-03 |
| 43474 | 1378045048 | K191325 | EMPOWR Partial Knee | HSX | 2019-07-16 |
| 43474 | 1827259561 | K190290 | AltiVate Reverse Humeral Stem, 48mm | KWS | 2019-04-26 |
| 43474 | 1375879442 | K190057 | DJO Acetabular System | LPH | 2019-06-07 |
| 43474 | 1062263056 | K180930 | EMPOWR VVC TIBIAL INSERT | JWH | 2018-07-09 |
| 43474 | 1883312455 | K173723 | EMPOWR Universal Tibial Baseplate | JWH | 2018-03-05 |
| 43474 | 1393743590 | K173073 | AltiVate Anatomic to Reverse Conversion Module | PHX | 2017-12-26 |
| 43474 | 1751617795 | K172651 | FMP Extended Liners | OQG | 2017-12-13 |
| 43474 | 1708437779 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert | KWS | 2017-10-30 |
| 43474 | 1810277605 | K171991 | EMPOWR Porous Knee System | MBH | 2017-10-04 |
| 43474 | 1567843174 | K170573 | Empowr CR Knee Tibial Insert | JWH | 2017-05-31 |
| 43474 | 1356459852 | K163497 | EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt | KWZ | 2017-03-02 |
| 43474 | 1699973478 | K162024 | AltiVate Anatomic Shoulder System | KWS | 2016-11-21 |
| 43474 | 1996102870 | K161945 | EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) | JWH | 2016-09-23 |
| 43474 | 2046901873 | K161610 | EXPRT Revision Hip System | KWZ | 2016-11-09 |
| 43474 | 1824256735 | K160342 | EMPOWR PS Knee System | JWH | 2016-05-19 |
| 43474 | 1537875947 | K143242 | Rebel 3DKNEE System | JWH | 2015-05-15 |
| 43474 | 1490665337 | K141990 | ENCORE HUMERAL SHOULDER STEM | PHX | 2014-11-07 |
| 43474 | 1858107875 | K141006 | RSP HUMERAL SOCKET INSERT | PHX | 2014-06-05 |
| 43474 | 1325456797 | K140830 | EXPRT REVISION KNEE | JWH | 2014-07-11 |
| 43474 | 1170560797 | K140130 | X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED | OQG | 2014-11-06 |
| 43474 | 1842485364 | K130365 | X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER | OQG | 2013-09-23 |
| 43474 | 1276520433 | K130099 | TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 | LPH | 2013-06-21 |
| 43474 | 1864431292 | K130048 | REVERSE SHOULDER PROSTHESIS MONOBLOCK | KWS | 2013-10-29 |
| 43474 | 1273516411 | K123982 | TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ | KWS | 2013-01-23 |
| 43474 | 1995306690 | K122636 | REVELATION POROUS COATED HIP STEM, SIZE 8 | LPH | 2012-11-02 |
| 43474 | 1659664226 | K122239 | FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING | JWH | 2013-04-11 |
| 43474 | 1611307495 | K121835 | DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE | JWH | 2012-07-20 |
| 43474 | 1775860091 | K121727 | MOVATION KNEE SYSTEM | OIY | 2012-08-15 |
| 43474 | 1373567827 | K120241 | LINEAR HIP STEM, SIZE 5 | LPH | 2012-02-24 |
| 43474 | 1276445272 | K113756 | HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA | OIY | 2012-03-14 |
| 43474 | 1290676100 | K112069 | RSP GLENOID BASEPLATE POROUS COATED | PHX | 2011-11-15 |
| 43474 | 1062807262 | K111735 | REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER | PHX | 2011-10-03 |
| 43474 | 1420228710 | K111629 | TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 | PHX | 2011-09-16 |
| 43474 | 1434964583 | K111061 | REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) | PHX | 2011-07-20 |
| 43474 | 1364837507 | K103208 | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM | PHX | 2011-01-31 |
| 43474 | 1475991419 | K100900 | MOTIVATION KNEE SYSTEM | JWH | 2010-06-18 |
| 43474 | 1133564489 | K100741 | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 | PHX | 2010-08-02 |
| 43474 | 1800895654 | K092873 | REVERSE SHOULDER PROSTHESIS | PHX | 2009-10-27 |
| 43474 | 1167722678 | K092331 | DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; | KWA | 2010-03-03 |
| 43474 | 1250432451 | K092150 | COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT | LOD | 2009-10-27 |
| 43474 | 1343395868 | K091956 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 | OIY | 2010-09-28 |
| 43474 | 1161000108 | K091608 | COBALT MV BONE CEMENT | LOD | 2009-09-17 |
| 43474 | 1100169508 | K090473 | DISCOVERY ELBOW - X-SMALL | JDC | 2009-03-25 |
| 43474 | 1165074285 | K083651 | REVELATION STEM, MODEL 427-21/42-080/180 | KWA | 2009-03-13 |
| 43474 | 1311002493 | K082844 | BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE | LZO | 2008-11-25 |
| 43474 | 1967130918 | K081679 | REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 | LPH | 2008-08-20 |
| 43474 | 1516785810 | K081448 | ENCORE SHOULDER REVISION GLENOID | MBF | 2008-09-30 |
| 43474 | 1761698478 | K080402 | ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 | KWS | 2008-03-28 |
| 43474 | 1024099432 | K072888 | REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) | LPH | 2008-01-10 |
| 43474 | 1572586791 | K072154 | FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM | LPH | 2007-12-14 |
| 43474 | 2003871622 | K063257 | FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT | LPH | 2006-11-22 |
| 43474 | 1794143654 | K052320 | ENCORE CLP OFFSET TOTAL HIP SYSTEM | KWA | 2005-12-30 |
| 43474 | 1753159480 | K052086 | ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER | PHX | 2005-08-31 |
| 43474 | 1905195772 | K051975 | POROUS COATED DISCOVERY ELBOW | JDC | 2005-09-06 |
| 43474 | 1210963168 | K051532 | COBALT G HV BONE CEMENT | LOD | 2005-08-03 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JWH | 27 | 2025-07-02 |
| LPH | 24 | 2025-11-12 |
| PHX | 14 | 2024-05-29 |
| JDI | 13 | 2002-07-23 |
| KWS | 11 | 2023-06-23 |
| LZO | 5 | 2025-02-07 |
| KWA | 5 | 2010-03-03 |
| MBH | 4 | 2022-01-20 |
| LOD | 4 | 2009-10-27 |
| OQG | 3 | 2017-12-13 |
| KWZ | 3 | 2017-03-02 |
| OIY | 3 | 2012-08-15 |
| JDC | 3 | 2009-03-25 |
| LWJ | 3 | 2005-01-25 |
| HSB | 3 | 1998-06-01 |
| HWC | 3 | 1998-03-12 |
| HRY | 2 | 2002-08-23 |
| PKC | 1 | 2020-06-03 |
| HSX | 1 | 2019-07-16 |
| NTG | 1 | 2009-05-27 |
| MBF | 1 | 2008-09-30 |
| MEH | 1 | 2000-02-04 |
| KWT | 1 | 1999-06-29 |
| KWL | 1 | 1997-12-18 |
| LXT | 1 | 1996-10-23 |
| KWY | 1 | 1995-08-09 |
| HSD | 1 | 1995-05-22 |
Encore Medical L.P.
Encore Medical L.P.
Encore Medical L.P.
Encore Medical, L.P. (Dba Enovis)
Encore Medical L.P.
Encore Medical, L.P Dba Enovis
Encore Medical, L.P Dba Enovis
Encore Medical, LLC
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P. Dba DJO Surgical
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P.
Encore Medical, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P
Encore Medical, L.P.
ENCORE MEDICAL, L.P.
Encore Medical, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P.
ENCORE MEDICAL, L.P.
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