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 |
|---|---|---|---|
| Jan 8, 2004 | K033338 | PINNACLE REVISION SYSTEM DePuy Orthopaedics, Inc. | LPH |
| Dec 3, 2003 | K032729 | Z-SERIES MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | LPH |
| Nov 13, 2003 | K032964 | EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS Exactech, Inc. | LPH |
| Nov 5, 2003 | K033034 | VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS Zimmer, Inc. | LPH |
| Oct 30, 2003 | K032385 | GLOBAL PRESS-FIT STEM Global Medical Co. | LPH |
| Oct 22, 2003 | K032726 | ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES Zimmer, Inc. | LPH |
| Oct 9, 2003 | K032581 | GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT Howmedica Osteonics Corp. | LPH |
| Aug 11, 2003 | K030055 | MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS Biomet, Inc. | LPH |
| Aug 6, 2003 | K031693 | MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA Biomet, Inc. | LPH |
| Jun 24, 2003 | K031572 | ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 Zimmer, Inc. | LPH |
| Jun 12, 2003 | K030861 | HA PMI FLANGED ACETABULAR COMPONENT Biomet, Inc. | LPH |
| Jun 11, 2003 | K031495 | PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| May 22, 2003 | K031110 | APEX MODULAR ACETABULAR CUP Apex Surgical, LLC | LPH |
| May 1, 2003 | K030733 | MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES Zimmer, Inc. | LPH |
| Apr 24, 2003 | K030979 | MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| Mar 20, 2003 | K030501 | X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS Biomet, Inc. | LPH |
| Mar 4, 2003 | K021878 | ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS Eska America Corp. | LPH |
| Feb 25, 2003 | K022520 | U2 ACETABULAR CUP United Orthopedic Corp., TW | LPH |
| Feb 20, 2003 | K030236 | ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT Exactech, Inc. | LPH |
| Feb 5, 2003 | K030079 | VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS Zimmer, Inc. | LPH |
| Feb 5, 2003 | K030048 | HA PMI FEMORAL HIP STEM Biomet Orthopedics, Inc. | LPH |
| Nov 8, 2002 | K023409 | HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS Biomet, Inc. | LPH |
| Nov 6, 2002 | K023357 | ARCPM 1050 RESIN-HIPS Biomet Orthopedics, Inc. | LPH |
| Oct 25, 2002 | K023375 | MODIFICATION TO ESOP CO-CR FEMORAL HEADS Pro-Active Healthcare | LPH |
| Oct 4, 2002 | K022382 | RHS ACETABULAR COMPONENT Signal Medical Corp. | LPH |
| Oct 2, 2002 | K022902 | SMITH & NEPHEW HIP SYSTEM Smith & Nephew, Inc. | LPH |
| Sep 5, 2002 | K021891 | ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM Zimmer, Inc. | LPH |
| Aug 28, 2002 | K022556 | REFLECTION MODIFIED ACETABULAR SHELLS Smith & Nephew, Inc. | LPH |
| Aug 26, 2002 | K022711 | MODIFICATION TO AVALON CUP SYSTEM Orthopedic Source, Inc. | LPH |
| Aug 16, 2002 | K022463 | HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS Biomet Orthopedics, Inc. | LPH |
| Jul 30, 2002 | K014070 | EPOCH HIP PROSTHESIS, MODEL 4075 SERIES Zimmer, Inc. | LPH |
| Jul 24, 2002 | K021466 | CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE Hayes Medical, Inc. | LPH |
| Jul 12, 2002 | K021970 | THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) Implex Corp. | LPH |
| Jul 2, 2002 | K021911 | TRIDENT CROSSFIRE POLYUETHYLENE LINERS Howmedica Osteonics Corp. | LPH |
| Jul 2, 2002 | K021346 | STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX Wrightmedicaltechnologyinc | LPH |
| Jun 12, 2002 | K021109 | ESOP CO-CR FEMORAL HEADS Fournitures Hospitalieres | LPH |
| Apr 15, 2002 | K020153 | CONSENSUS ACETABLAR SHELL, TI COATED Hayes Medical, Inc. | LPH |
| Apr 15, 2002 | K020145 | ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM Orthopaedic Innovations, Inc. | LPH |
| Mar 22, 2002 | K020580 | X-SERIES BI-METRIC HIP FEMORAL COMPONENTS Biomet, Inc. | LPH |
| Mar 15, 2002 | K012787 | VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE Smith & Nephew, Inc. | LPH |
| Mar 4, 2002 | K020497 | TRIDENT ELEVATED RIM LINER Howmedica Osteonics Corp. | LPH |
| Feb 11, 2002 | K020170 | KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP Encore Orthopedics, Inc. | LPH |
| Jan 17, 2002 | K013490 | CEMENTED CALCAR HIP SYSTEM Encore Orthopedics, Inc. | LPH |
| Dec 20, 2001 | K013475 | TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING Howmedica Osteonics Corp. | LPH |
| Dec 5, 2001 | K013658 | MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS Smith & Nephew, Inc. | LPH |
| Nov 14, 2001 | K012739 | CONVERGE ACETABULAR SYSTEM Sulzer Orthopedics, Inc. | LPH |
| Oct 19, 2001 | K012364 | AML HIP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| Aug 30, 2001 | K012507 | THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) Implex Corp. | LPH |
| Jul 31, 2001 | K011489 | SUMMIT DUOFIX HIP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| Apr 24, 2001 | K011081 | ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS Exactech, Inc. | LPH |
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