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 |
|---|---|---|---|
| Apr 18, 2001 | K010170 | TRIDENT POROUS TITANIUM ACETABULAR COMPONENT Howmedica Osteonics Corp. | LPH |
| Apr 6, 2001 | K010171 | DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER DePuy Orthopaedics, Inc. | LPH |
| Mar 9, 2001 | K010367 | MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM DePuy Orthopaedics, Inc. | LPH |
| Mar 1, 2001 | K003875 | TI-REPLICA HIP STEM DePuy Orthopaedics, Inc. | LPH |
| Feb 15, 2001 | K004032 | PERFECTA AND EXTEND Wrightmedicaltechnologyinc | LPH |
| Feb 9, 2001 | K010282 | LATERAL OFFSET PROTRACT PRESS FIT HIP STEM Stelkast Company | LPH |
| Feb 9, 2001 | K010120 | MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S Exactech, Inc. | LPH |
| Feb 9, 2001 | K003800 | AML HIP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| Feb 8, 2001 | K010241 | PROTRACT PRESS FIT HIP STEM-HA COATED Stelkast Company | LPH |
| Feb 5, 2001 | K003478 | TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 Zimmer, Inc. | LPH |
| Jan 10, 2001 | K003237 | U2 HIP STEM, TI POROUS COATED United Orthopedic Corp., TW | LPH |
| Jan 10, 2001 | K003199 | TRIAD II MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | LPH |
| Dec 15, 2000 | K003447 | PROTRACT PRESS FIT HIP STEM Stelkast Company | LPH |
| Dec 15, 2000 | K002747 | REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS Smith & Nephew, Inc. | LPH |
| Dec 11, 2000 | K002960 | TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 Zimmer, Inc. | LPH |
| Dec 4, 2000 | K994078 | U1 HIP SYSTEM United Orthopedic Corp., TW | LPH |
| Nov 30, 2000 | K003429 | MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL Biomet, Inc. | LPH |
| Nov 7, 2000 | K003181 | IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ Implex Corp. | LPH |
| Aug 31, 2000 | K002149 | LINEAGE ACETABULAR SYSTEM Wrightmedicaltechnologyinc | LPH |
| Aug 25, 2000 | K001991 | TITAN POROCOAT HIP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| Aug 4, 2000 | K000788 | APEX MODULAR HIP STEM Apex Surgical, LLC | LPH |
| Jul 26, 2000 | K001982 | TRI-LOCK HIP STEM DePuy Orthopaedics, Inc. | LPH |
| Jul 7, 2000 | K001778 | POROCOAT PRODIGY HIP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| Jul 7, 2000 | K001320 | SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM Sulzer Orthopedics, Inc. | LPH |
| Jun 23, 2000 | K001277 | TRIFLANGE ACETABULAR CUP SYSTEM DePuy Orthopaedics, Inc. | LPH |
| Jun 15, 2000 | K001039 | THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP Implex Corp. | LPH |
| Jun 14, 2000 | K001660 | MALLORY HEAD MODULAR CALCAR Biomet Orthopedics, Inc. | LPH |
| Jun 12, 2000 | K001534 | PINNACLE ACETABULAR SYSTEM DePuy Orthopaedics, Inc. | LPH |
| May 23, 2000 | K000760 | REACH FEMORAL COMPONENT Biomet, Inc. | LPH |
| May 10, 2000 | K000521 | KEYSTONE HIP Encore Orthopedics, Inc. | LPH |
| Apr 11, 2000 | K990830 | MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS Biomet, Inc. | LPH |
| Apr 10, 2000 | K000321 | HEMISPHERE MODULAR CUP SYSTEM Ortho Development Corp. | LPH |
| Apr 6, 2000 | K993027 | ESKA MODULAR HIP SYSTEM Specs USA, Inc. | LPH |
| Apr 6, 2000 | K992154 | BICON-PLUS ACETABULAR COMPONENTS Plus Orthopedics | LPH |
| Mar 23, 2000 | K000306 | PINNACLE ACETABULAR SYSTEM DePuy Orthopaedics, Inc. | LPH |
| Mar 15, 2000 | K000538 | MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL Biomet, Inc. | LPH |
| Mar 10, 2000 | K994286 | ZMR HIP SYSTEM-POROUS REVISION Zimmer, Inc. | LPH |
| Mar 10, 2000 | K993259 | INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS Sulzer Orthopedics, Inc. | LPH |
| Feb 25, 2000 | K000335 | MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM Biomet, Inc. | LPH |
| Feb 16, 2000 | K000334 | IMPACT MODULAR TOTAL HIP SYSTEM Biomet, Inc. | LPH |
| Feb 4, 2000 | K000207 | POROCOAT PRODIGY HIP PROSTHESIS DePuy Orthopaedics, Inc. | LPH |
| Feb 3, 2000 | K994415 | MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS DePuy Orthopaedics, Inc. | LPH |
| Jan 20, 2000 | K994070 | REVELATION POROUS HIP STEM Encore Orthopedics, Inc. | LPH |
| Jan 20, 2000 | K993736 | EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT Exactech, Inc. | LPH |
| Dec 22, 1999 | K994038 | MODULAR REACH HIP Biomet, Inc. | LPH |
| Dec 20, 1999 | K990849 | DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) Howmedica Osteonics Corp. | LPH |
| Nov 19, 1999 | K993352 | CROSSFIRE SYSTEM 12 ACETABULAR INSERTS Howmedica Osteonics Corp. | LPH |
| Nov 19, 1999 | K993082 | EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT Exactech, Inc. | LPH |
| Oct 27, 1999 | K992667 | ZMR HIP SYSTEM-REVISION TAPER Zimmer, Inc. | LPH |
| Oct 22, 1999 | K991026 | REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS Smith & Nephew, Inc. | LPH |
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