Panels › Orthopedic › Product code LPH · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation 888.3358
11510(k)s in 12 months (565 all time)
3recalls in 12 months (299 all time)
269recalls that name a 510(k)
Top companies in LPH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 46 | 56 |
| Biomet, Inc. | 44 | 43 |
| DePuy Orthopaedics, Inc. | 33 | 23 |
| Zimmer Biomet | 1 | 48 |
| Howmedica Osteonics | 16 | 31 |
| Exactech, Inc. | 19 | 26 |
| Smith & Nephew, Inc. | 32 | 4 |
| Depuy, Inc. | 24 | 0 |
| Encore Medical L.P. | 13 | 11 |
| Howmedica Corp. | 18 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2006 | K060072 | MONOBLOCK PRESS-FIT HIP STEM Omni Life Science, Inc. | LPH |
| Aug 22, 2006 | K061434 | TRIDENT LARGE DIAMETER HIP SYSTEM Howmedica Osteonics Corp. | LPH |
| Aug 2, 2006 | K061226 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE Zimmer, Inc. | LPH |
| Jul 24, 2006 | K061786 | VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS Zimmer, Inc. | LPH |
| Jul 20, 2006 | K053417 | M-COR HIP REPLACEMENT SYSTEM Portland Orthopaedics Pty. , Ltd. | LPH |
| Jul 18, 2006 | K061168 | PCA 36MM FEMORAL HEADS Howmedica Osteonics Corp. | LPH |
| Jul 18, 2006 | K061124 | ORTHOPEDIC SOURCE PRESS-FIT HIP Orthopedic Source, Inc. | LPH |
| Jul 17, 2006 | K061833 | DEPUY AML HIP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| Jul 3, 2006 | K061547 | DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER Wrightmedicaltechnologyinc | LPH |
| Jun 14, 2006 | K060630 | REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING Smith & Nephew, Inc. | LPH |
| May 25, 2006 | K061067 | TRABECULAR METAL ACETABULAR AUGMENTS Zimmer Trabecular | LPH |
| May 19, 2006 | K060581 | DEPUY SOLUTION SYSTEM HIP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| May 12, 2006 | K060040 | ZIMMER M/L TAPER HIP PROSTHESIS Zimmer, Inc. | LPH |
| Apr 28, 2006 | K060635 | CONSENSUS ACETABULAR SHELL SYSTEM Hayes Medical, Inc. | LPH |
| Apr 28, 2006 | K052996 | POROUS TITANIUM ACETABULAR SHELLS Biomet Manufacturing Corp | LPH |
| Feb 17, 2006 | K052089 | XR-SERIES BI-METRIC FEMORAL COMPONENTS Biomet Manufacturing, Inc. | LPH |
| Feb 16, 2006 | K053293 | ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS Ortho Development Corp. | LPH |
| Feb 15, 2006 | K052321 | VERSYS EPOCH FULLCOAT HIP PROSTHESIS Zimmer, Inc. | LPH |
| Jan 31, 2006 | K060031 | DEPUY MODULAR M HEADS DePuy Orthopaedics, Inc. | LPH |
| Jan 20, 2006 | K053557 | ESKA-LIBUR HIP STEM Eska Implants GmbH & Co. | LPH |
| Dec 5, 2005 | K052026 | LINEAGE A-CLASS POLY LINER Wrightmedicaltechnologyinc | LPH |
| Nov 23, 2005 | K052255 | ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS Biomet, Inc. | LPH |
| Sep 27, 2005 | K050327 | E-POLY (VITAMIN E) ACETABULAR LINERS Biomet, Inc. | LPH |
| Sep 6, 2005 | K051556 | ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE Exactech, Inc. | LPH |
| Jun 30, 2005 | K051491 | TRABECULAR METAL PRIMARY HIP PROSTHESIS Zimmer, Inc. | LPH |
| May 11, 2005 | K050937 | TRABECULAR METAL ACETABULAR REVISION SHELLS Zimmer Trabecular | LPH |
| Apr 28, 2005 | K042989 | RX90 LOW PROFILE ACETABULAR SYSTEM Biomet, Inc. | LPH |
| Apr 11, 2005 | K042565 | ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER Ortho Development Corp. | LPH |
| Mar 8, 2005 | K042051 | ARCOMXL POLYETHYLENE LINERS Biomet, Inc. | LPH |
| Feb 10, 2005 | K043123 | APEX MODULAR HA HIP STEM Apex Surgical, LLC | LPH |
| Feb 10, 2005 | K033716 | TRIDENT ACETABULAR SYSTEM Howmedica Osteonics Corp. | LPH |
| Jan 21, 2005 | K042774 | MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS Biomet, Inc. | LPH |
| Jan 14, 2005 | K043537 | TAPERLOC 12/14 TAPER FEMORAL COMPONENTS Biomet, Inc. | LPH |
| Dec 21, 2004 | K042871 | TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 Zimmer Trabecular | LPH |
| Dec 21, 2004 | K041950 | APEX K2 HIP SYSTEM Apex Surgical, LLC | LPH |
| Dec 21, 2004 | K041850 | MEDALLION MODULAR HIP SYSTEM Biomet Manufacturing, Inc. | LPH |
| Dec 6, 2004 | K042252 | NEXFLEX TOTAL HIP SYSTEM Alphatec/Nexmed | LPH |
| Nov 22, 2004 | K031402 | PERFECTA FEMORAL STEM Wrightmedicaltechnologyinc | LPH |
| Nov 9, 2004 | K042029 | X-SERIES INTEGRAL RPP FEMORAL COMPONENTS Biomet, Inc. | LPH |
| Nov 4, 2004 | K042776 | VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX Zimmer, Inc. | LPH |
| Nov 4, 2004 | K042337 | ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING Zimmer, Inc. | LPH |
| Sep 10, 2004 | K041906 | EXACTECH 12/14 TOTAL HIP SYSTEM Exactech, Inc. | LPH |
| Aug 25, 2004 | K040191 | BICONTACT HIP STEM AND FEMORAL HEAD Aesculap | LPH |
| Aug 5, 2004 | K033580 | NEXFLEX TOTAL HIP SYSTEM Nexmed, Inc. | LPH |
| Jul 20, 2004 | K041109 | ZIMMER ANATOMIC II HIP PROSTHESIS Zimmer, Inc. | LPH |
| May 28, 2004 | K040544 | DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 Depuy, Inc. | LPH |
| May 25, 2004 | K040412 | TRIDENT T ACETABULAR SHELLS Stryker Orthopaedics | LPH |
| May 12, 2004 | K040383 | TRIFLANGE II ACETABULAR CUP SYSTEM DePuy Orthopaedics, Inc. | LPH |
| May 6, 2004 | K033273 | DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS DePuy Orthopaedics, Inc. | LPH |
| Mar 12, 2004 | K033893 | SPECTRUM MODULAR SYSTEM DePuy Orthopaedics, Inc. | LPH |
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