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 18, 1995 | K934060 | HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE Howmedica Corp. | LPH |
| Aug 14, 1995 | K933882 | OSTEONICS PS HEMI-HIP STEM SERIES Osteonics Corp. | LPH |
| Aug 7, 1995 | K951741 | REPLICA TOTAL HIP SYSTEM Osteo-Technology Intl., Inc. | LPH |
| Jul 21, 1995 | K952397 | VITALOCK SOLID BACKED ACETABULAR SHELL Howmedica Corp. | LPH |
| Jul 6, 1995 | K941612 | F-230 POROUS FEMORAL HIP STEM (CEMENTLESS) Implex Corp. | LPH |
| Jun 19, 1995 | K951356 | VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED Biologically Oriented Prostheses | LPH |
| Jun 16, 1995 | K951115 | HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS Howmedica Corp. | LPH |
| Jun 16, 1995 | K951114 | SYSTEM 12 P1 26MM ACETABULAR INSERT Howmedica Corp. | LPH |
| Jun 7, 1995 | K940715 | OSTEONICS OMNIFIT AD HIP STEM SERIES Osteonics Corp. | LPH |
| Jun 7, 1995 | K936310 | ORTHOMET HMC FEMORAL STEM COMPONENT Orthomet, Inc. | LPH |
| May 17, 1995 | K944592 | PRECISION OSTEOLOCK FEMORAL COMPONENT Howmedica Corp. | LPH |
| May 11, 1995 | K951674 | DEPUY DURALOC 100C ACETABULAR CUP Depuy, Inc. | LPH |
| Apr 27, 1995 | K951095 | 10.5MM REPLICA HIP STEM Depuy, Inc. | LPH |
| Apr 18, 1995 | K951301 | DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM Depuy, Inc. | LPH |
| Apr 18, 1995 | K950827 | PROFORM POROUS ACETABULAR ASSEMBLY Stelkast Company | LPH |
| Apr 14, 1995 | K951000 | ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM Joint Medical Products Corp. | LPH |
| Mar 7, 1995 | K934515 | BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB) Zimmer, Inc. | LPH |
| Jan 11, 1995 | K921525 | HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS Implant Technology, Inc. | LPH |
| Dec 21, 1994 | K934334 | APOGEE HIP STEM WITH POROCOAT Depuy, Inc. | LPH |
| Oct 14, 1994 | K931333 | ORTHOMET ACETABULAR CUP SYSTEM Orthomet, Inc. | LPH |
| Oct 4, 1994 | K943054 | OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM Osteonics Corp. | LPH |
| Sep 28, 1994 | K942115 | INFINITY REVISION HIP STEM Wrightmedicaltechnologyinc | LPH |
| Sep 28, 1994 | K941141 | PRECISION OSTELOCK SP FEMORAL COMPONENT Howmedica Corp. | LPH |
| Jul 29, 1994 | K935875 | OSTEONICS SCREWLESS ACETABULAR COMPONENTS Osteonics Corp. | LPH |
| Jun 6, 1994 | K935484 | PROVIDENT HIP SYSTEM Stelkast Company | LPH |
| Jun 3, 1994 | K934412 | COATED ZT PROXIMAL SLEEVE Joint Medical Products Corp. | LPH |
| May 16, 1994 | K933102 | HOWMEDICA ACETABULAR SHELL W/SCREW HOLES Howmedica Corp. | LPH |
| May 12, 1994 | K932924 | IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED Implex Corp. | LPH |
| May 6, 1994 | K932755 | REFLECTION ACETABULAR COMPONENT Smith & Nephew Richards, Inc. | LPH |
| May 3, 1994 | K932923 | IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS Implex Corp. | LPH |
| Apr 29, 1994 | K934765 | TRILOGY ACETABULAR SYSTEM Zimmer, Inc. | LPH |
| Apr 29, 1994 | K931642 | RMHS MONOLITHIC FEMORAL COMPONENT Smith & Nephew Richards, Inc. | LPH |
| Apr 13, 1994 | K933787 | POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM Depuy, Inc. | LPH |
| Mar 21, 1994 | K931641 | POROCOAT POROUS COATING Depuy, Inc. | LPH |
| Mar 9, 1994 | K926156 | REPLICA(TM) TOTAL HIP SYSTEM Osteo Technology, Inc. | LPH |
| Mar 3, 1994 | K935731 | ACETABULAR SHELL Howmedica Corp. | LPH |
| Feb 22, 1994 | K925172 | PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE) Howmedica Corp. | LPH |
| Feb 22, 1994 | K922071 | ZIMMER ANATOMIC HIP SYSTEM Zimmer, Inc. | LPH |
| Feb 22, 1994 | K921557 | BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT Zimmer, Inc. | LPH |
| Feb 22, 1994 | K921308 | HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM Zimmer, Inc. | LPH |
| Feb 16, 1994 | K923452 | PMI HIP FEMORAL Biomet, Inc. | LPH |
| Feb 16, 1994 | K921301 | TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM Biomet, Inc. | LPH |
| Feb 16, 1994 | K921277 | RANAWAT/BURSTEIN TOTAL HIP SYSTEM Biomet, Inc. | LPH |
| Feb 15, 1994 | K921274 | METALLIC TOATAL HIP SYSTEM Biomet, Inc. | LPH |
| Feb 9, 1994 | K920955 | APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE Intermedics Orthopedics | LPH |
| Jan 7, 1994 | K922500 | PSL TOTAL HIP REPLACEMENT SYSTEM Biopro, Inc. | LPH |
| Oct 27, 1993 | K921114 | EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR Exactech, Inc. | LPH |
| Oct 27, 1993 | K921113 | EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM Exactech, Inc. | LPH |
| Oct 15, 1993 | K922159 | INFINITY POROUS-COATED TROCHANTERIC MODULE Wrightmedicaltechnologyinc | LPH |
| Jul 28, 1993 | K926107 | ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS Biomet, Inc. | LPH |
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