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 12, 1999 | K992109 | ENCORE FULLY COATED HIP Encore Orthopedics, Inc. | LPH |
| Jul 12, 1999 | K991485 | SYNERGY POROUS SIZE 8 HIP STEM Smith & Nephew, Inc. | LPH |
| Jul 12, 1999 | K990135 | TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE Zimmer, Inc. | LPH |
| Jul 8, 1999 | K991807 | TITANIUM LOW PROFILE SCREWS Biomet, Inc. | LPH |
| Jul 1, 1999 | K983837 | HEDROCEL ACETABULAR CAGE SYSTEM Implex Corp. | LPH |
| Jun 25, 1999 | K991325 | MODIFICATION OF ENCORE LINEAR POROUS COATED HIP Encore Orthopedics, Inc. | LPH |
| Jun 1, 1999 | K991123 | PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM Wrightmedicaltechnologyinc | LPH |
| Apr 30, 1999 | K990523 | B2C, ESPACE REVISION CUP SYSTEM Turnkey Intergration USA, Inc. | LPH |
| Mar 15, 1999 | K984492 | TIGRAN HIP PROSTHESIS Ponmed , Ltd. | LPH |
| Feb 24, 1999 | K990003 | J-SERIES OMEGA TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | LPH |
| Feb 24, 1999 | K983834 | ECHELON HIP STEM Smith & Nephew, Inc. | LPH |
| Feb 18, 1999 | K984296 | LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT Biomet, Inc. | LPH |
| Feb 12, 1999 | K984408 | 130 MODIFIED INTEGRAL FEMORAL COMPONENT Biomet, Inc. | LPH |
| Feb 3, 1999 | K983509 | INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT Sulzer Orthopedics, Inc. | LPH |
| Jan 28, 1999 | K984459 | DEPUY PROFILE FEMORAL HIP WITH POROCOAT DePuy Orthopaedics, Inc. | LPH |
| Dec 16, 1998 | K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM Osteonics Corp. | LPH |
| Dec 2, 1998 | K983491 | DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER DePuy Orthopaedics, Inc. | LPH |
| Nov 23, 1998 | K983035 | CUSTOM FLANGED ACETABULAR COMPONENT Biomet, Inc. | LPH |
| Nov 12, 1998 | K980711 | HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING Zimmer, Inc. | LPH |
| Oct 27, 1998 | K983014 | SUMMIT ACETABULAR SYSTEM Johnson & Johnson Professionals, Inc. | LPH |
| Aug 31, 1998 | K982248 | HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A Howmedica, Inc. | LPH |
| Aug 24, 1998 | K982367 | REACH HIP COMPONENT Biomet, Inc. | LPH |
| May 22, 1998 | K981211 | APR -T REVISION HIP STEM Sulzer Orthopedics, Inc. | LPH |
| May 20, 1998 | K980981 | OMEGA HA COATED TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | LPH |
| Apr 3, 1998 | K980020 | ACTIVELOCK MODULAR FEMORAL HIP SYSTEM Metagen, LLC | LPH |
| Mar 18, 1998 | K974740 | DEPUY TRI-LOCK HIP STEM Depuy, Inc. | LPH |
| Feb 27, 1998 | K974506 | LSF HA COATED TRIAD TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | LPH |
| Feb 11, 1998 | K971206 | MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING Howmedica Corp. | LPH |
| Feb 6, 1998 | K974331 | UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM Johnson & Johnson Professionals, Inc. | LPH |
| Jan 28, 1998 | K974095 | FOUNDATION POROUS COATED FLARED RIM SHELL Encore Orthopedics, Inc. | LPH |
| Jan 28, 1998 | K974093 | FOUNDATION POROUS COATED HEMISPHERICAL SHELL Encore Orthopedics, Inc. | LPH |
| Jan 28, 1998 | K973119 | FOUNDATION POROUS ACETABULAR SYSTEM Encore Orthopedics, Inc. | LPH |
| Jan 12, 1998 | K974294 | ENCORE LINEAR POROUS COATED HIP Encore Orthopedics, Inc. | LPH |
| Dec 24, 1997 | K973714 | VERSYS HIP SYSTEM BEADED HIP PROSTHESIS Zimmer, Inc. | LPH |
| Dec 19, 1997 | K973685 | REVELATION POROUS HIP STEM Encore Orthopedics, Inc. | LPH |
| Dec 19, 1997 | K973675 | NATURAL-HIP POROUS STEM WITH OFFSET Sulzer Orthopedics, Inc. | LPH |
| Dec 4, 1997 | K971824 | REACH FEMORAL HIP COMPONENT Biomet, Inc. | LPH |
| Dec 2, 1997 | K973302 | FOUNDATION POROUS HIP STEM Encore Orthopedics, Inc. | LPH |
| Nov 21, 1997 | K973163 | ACETABULAR SHELLS WITH MESH INGROWTH SURFACE Howmedica Corp. | LPH |
| Nov 12, 1997 | K972596 | DEPUY DURALOC ACETABULAR CUP SYSTEM Depuy, Inc. | LPH |
| Nov 3, 1997 | K973124 | APR POROUS HA HIP SYSTEM Sulzer Orthopedics, Inc. | LPH |
| Oct 24, 1997 | K971018 | SMC ACETABULAR COMPONENT Signal Medical Corp. | LPH |
| Oct 16, 1997 | K973530 | INFINTY DISTAL FEMORAL COMPONENT Wrightmedicaltechnologyinc | LPH |
| Sep 19, 1997 | K972393 | INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI) Sulzer Orthopedics, Inc. | LPH |
| Aug 14, 1997 | K970241 | DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS Depuy, Inc. | LPH |
| Aug 7, 1997 | K964616 | QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT Whiteside Biomechanics, Inc. | LPH |
| Jul 30, 1997 | K971854 | OSTEOLOCK ACETABULAR SHELL SYSTEM Howmedica Corp. | LPH |
| Jul 23, 1997 | K971718 | MICRO-SEAL ACETABULAR SYSTEM Whiteside Biomechanics, Inc. | LPH |
| Jul 9, 1997 | K971429 | INTERSEAL ACETABULAR SCREW HOLE PLUG Wrightmedicaltechnologyinc | LPH |
| Jul 3, 1997 | K970300 | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI Intermedics Orthopedics | LPH |
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