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 |
|---|---|---|---|
| Jun 19, 1997 | K964650 | TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS Depuy, Inc. | LPH |
| Jun 19, 1997 | K964509 | IMPLEX A-240 HEP ACETABULAR CUP SYSTEM Implex Corp. | LPH |
| Jun 18, 1997 | K971020 | LSF TRIAD TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | LPH |
| May 22, 1997 | K970706 | INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES Sulzer Orthopedics, Inc. | LPH |
| May 22, 1997 | K970705 | INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES Sulzer Orthopedics, Inc. | LPH |
| Apr 30, 1997 | K970501 | PEGGED ACETABULAR COMPONENT Biomet, Inc. | LPH |
| Mar 13, 1997 | K965164 | HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR Howmedica Corp. | LPH |
| Mar 13, 1997 | K964882 | IMPLEX REPLACEMENT ACETABULAR CUP INSERT Implex Corp. | LPH |
| Mar 7, 1997 | K964924 | OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) Osteoimplant Technology, Inc. | LPH |
| Feb 13, 1997 | K964769 | VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS Zimmer, Inc. | LPH |
| Feb 12, 1997 | K963101 | B-P HEMISPHERICAL ACETABULAR COMPONENT Endotec, Inc. | LPH |
| Feb 12, 1997 | K963100 | TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP Endotec, Inc. | LPH |
| Jan 27, 1997 | K963998 | METAL BACKED ACETABULAR COMPONENT Encore Orthopedics, Inc. | LPH |
| Jan 27, 1997 | K963946 | OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) Osteonics Corp. | LPH |
| Jan 27, 1997 | K963509 | GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON Smith & Nephew Richards, Inc. | LPH |
| Jan 14, 1997 | K964227 | METAL ACETABULAR COMPONENT Encore Orthopedics, Inc. | LPH |
| Jan 14, 1997 | K943230 | MAYO HIP PROSTHESIS Mayo Clinic | LPH |
| Nov 12, 1996 | K963309 | APEX HOLE ELIMINATOR PS Depuy, Inc. | LPH |
| Oct 15, 1996 | K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED Intermedics Orthopedics | LPH |
| Oct 3, 1996 | K962769 | HORIZON HIP SYSTEM Biologically Oriented Prostheses | LPH |
| Oct 1, 1996 | K962923 | DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500) Depuy, Inc. | LPH |
| Sep 17, 1996 | K961526 | PRESS-FIT POROUS SHELL Encore Orthopedics, Inc. | LPH |
| Sep 17, 1996 | K961186 | DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM Depuy, Inc. | LPH |
| Sep 10, 1996 | K961625 | QUATROLOC FEMORAL COMPONENT & HEAD Whiteside Biomechanics, Inc. | LPH |
| Aug 13, 1996 | K961939 | S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) Johnson & Johnson Professionals, Inc. | LPH |
| Aug 9, 1996 | K955563 | FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS Encore Orthopedics, Inc. | LPH |
| Jun 21, 1996 | K960303 | FENNING FEMORAL COMPONENT Biomet, Inc. | LPH |
| May 8, 1996 | K960660 | HEMISPHERE ACETABULAR CUP Ortho Development Corp. | LPH |
| May 2, 1996 | K960180 | 22 MM COCR HEAD & POLYETHLENE LINER Stelkast Company | LPH |
| Mar 27, 1996 | K960172 | DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER Depuy, Inc. | LPH |
| Mar 27, 1996 | K955739 | MODULAR ACETABULAR SHELL II Intermedics Orthopedics | LPH |
| Mar 22, 1996 | K955871 | HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT Howmedica Corp. | LPH |
| Feb 26, 1996 | K955511 | ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP Joint Medical Products Corp. | LPH |
| Feb 9, 1996 | K955170 | NEXFLEX FEMORAL STEM, STANDARD DESIGN Nexmed, Inc. | LPH |
| Feb 1, 1996 | K953703 | DEPUY VISION SOLUTION HIP PROSTHESIS Depuy, Inc. | LPH |
| Feb 1, 1996 | K953694 | DEPUY VISION AML HIP PROTHESIS Depuy, Inc. | LPH |
| Jan 31, 1996 | K955033 | RIM FLARE ACETABULAR COMPONENT Intermedics Orthopedics | LPH |
| Jan 30, 1996 | K955271 | MICRO-SEAL ACETABULAR SYSTEM Whiteside Instruments | LPH |
| Jan 22, 1996 | K954935 | S-ROM FEMORAL HIP STEM - SIZE 14 X 8 Joint Medical Products Corp. | LPH |
| Jan 22, 1996 | K953337 | BETA HIP PROSTHESIS Zimmer, Inc. | LPH |
| Jan 17, 1996 | K954811 | DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT Depuy, Inc. | LPH |
| Jan 17, 1996 | K954698 | TRILOGY ACETABULAR COMPONENT 7MM OFFSET Zimmer, Inc. | LPH |
| Dec 11, 1995 | K954417 | A-B ACETABULAR COMPONENT Biomet, Inc. | LPH |
| Dec 4, 1995 | K954466 | PROFORM POROUS BEADED FEMORAL STEM Stelkast Company | LPH |
| Nov 30, 1995 | K954288 | EXTEND HIP SYSTEM Wrightmedicaltechnologyinc | LPH |
| Oct 25, 1995 | K954213 | ATH FULL PROFILE ACETABULAR CUP SYSTEM Kinamed, Inc. | LPH |
| Oct 23, 1995 | K953664 | VITALOCK SPIKED ACETABULAR SHELL Howmedica Corp. | LPH |
| Oct 20, 1995 | K953490 | TRILOGY ACETABULAR SHELL & LINERS 36MM Zimmer, Inc. | LPH |
| Aug 18, 1995 | K952740 | DEPUY DURALOC 400 ACETABULAR CUP Depuy, Inc. | LPH |
| Aug 18, 1995 | K936292 | PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS Howmedica Corp. | LPH |
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