Panels › Orthopedic › Product code LZO · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation 888.3353
9510(k)s in 12 months (535 all time)
0recalls in 12 months (177 all time)
168recalls that name a 510(k)
Top companies in LZO
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 34 | 35 |
| Stryker Howmedica Osteonics | 0 | 51 |
| Medacta International | 38 | 0 |
| Exactech, Inc. | 21 | 15 |
| Corin U.S.A. Limited | 27 | 5 |
| Biomet, Inc. | 21 | 8 |
| Howmedica Osteonics | 24 | 2 |
| Smith & Nephew, Inc. | 24 | 2 |
| Microport Orthopedics, Inc. | 13 | 8 |
| Howmedica Corp. | 19 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 19, 2005 | K051737 | MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE Howmedica Osteonics Corp. | LZO |
| Jul 19, 2005 | K051682 | EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM Exactech, Inc. | LZO |
| Jul 12, 2005 | K051588 | BIOLOX DELTA CERAMIC FEMORAL HEADS Howmedica Osteonics Corp. | LZO |
| Jun 29, 2005 | K051411 | ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS Biomet, Inc. | LZO |
| May 11, 2005 | K050556 | ALUMINA HEAD Fournitures Hospitalieres Industrie, FR | LZO |
| Apr 18, 2005 | K043356 | WAGNER SL REVISION STEM LATERAL Zimmer Austin, Inc. | LZO |
| Mar 25, 2005 | K042091 | BIOLOX DELTA CERAMIC HEADS Biomet, Inc. | LZO |
| Feb 11, 2005 | K042992 | CORAIL AMT HIP PROSTHESIS DePuy Orthopaedics, Inc. | LZO |
| Feb 11, 2005 | K041940 | HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS Howmedica Osteonics Corp. | LZO |
| Nov 17, 2004 | K042035 | ALUMINA HEAD Fournitures Hospitalieres Industrie, FR | LZO |
| Nov 16, 2004 | K041443 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM Osteoimplant Technology, Inc. | LZO |
| Nov 9, 2004 | K042842 | NOVATION 12/14 PRESS-FIT FEMORAL STEM Exactech, Inc. | LZO |
| Nov 9, 2004 | K041170 | SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS Howmedica Osteonics Corp. | LZO |
| Sep 15, 2004 | K042249 | CLS SPOTORNO STEM Zimmer Austin, Inc. | LZO |
| Aug 25, 2004 | K040734 | MODIFICATION TO RESTORATION MODULAR SYSTEM Howmedica Osteonics Corp. | LZO |
| Apr 29, 2004 | K040803 | MS-30 FEMORAL STEM STANDARD AND LATERAL Zimmer, Inc. | LZO |
| Apr 8, 2004 | K040644 | MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD DePuy Orthopaedics, Inc. | LZO |
| Mar 12, 2004 | K033944 | STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD Stelkast Company | LZO |
| Dec 17, 2003 | K033664 | MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM Centerpulse Orthopedics, Inc. | LZO |
| Oct 24, 2003 | K032348 | CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP Centerpulse Orthopedics, Inc. | LZO |
| Sep 22, 2003 | K032380 | WAGNER CONE PROSTHESIS Centerpulse Orthopedics, Inc. | LZO |
| Jul 1, 2003 | K031803 | DEPUY CERAMIC FEMORAL HEADS DePuy Orthopaedics, Inc. | LZO |
| Jun 3, 2003 | K030724 | ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM Zimmer, Inc. | LZO |
| May 23, 2003 | K031217 | GMRS PRESS FIT STEMS WITH PUREFIX HA Howmedica Osteonics | LZO |
| Apr 10, 2003 | K030151 | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM Hayes Medical, Inc. | LZO |
| Mar 6, 2003 | K030373 | ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM Centerpulse Orthopedics, Inc. | LZO |
| Jan 28, 2003 | K023901 | ALUMINA V40 FEMORAL HEADS Howmedica Osteonics Corp. | LZO |
| Dec 5, 2002 | K022985 | ASCENDENT ACETABULAR SYSTEM Sulzer Orthopedics, Inc. | LZO |
| Oct 17, 2002 | K022403 | GMRS PRESS FIT STEMS WITH PUREFIX HA Howmedica Osteonics Corp. | LZO |
| Sep 23, 2002 | K022549 | RESTORATION MODULAR SYSTEM Howmedica Osteonics Corp. | LZO |
| Aug 26, 2002 | K022555 | ACCOLADE C FEMORAL STEMS Howmedica Osteonics Corp. | LZO |
| Jul 24, 2002 | K022120 | MPF ACETABULAR CUP GENERATION 2 Plus Orthopedics | LZO |
| Jun 11, 2002 | K021673 | TOTAL HIP FEMORAL HEAD - 12/14 TAPER Smith & Nephew, Inc. | LZO |
| May 14, 2002 | K020713 | MS-30 LATERAL FEMORAL STEM Sulzer Orthopedics, Inc. | LZO |
| Apr 3, 2002 | K013106 | 2 PIECE MODULAR HIP STEM Howmedica Osteonics Corp. | LZO |
| Jan 28, 2002 | K011533 | DEPUY FEMORAL HEADS DePuy Orthopaedics, Inc. | LZO |
| Dec 19, 2001 | K013989 | ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER Smith & Nephew, Inc. | LZO |
| Dec 13, 2001 | K013935 | ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS Sulzer Orthopedics, Inc. | LZO |
| Nov 27, 2001 | K012918 | APEX MODULAR ALUMINA FEMORAL HEAD Apex Surgical, LLC | LZO |
| Oct 3, 2001 | K012091 | PRO-FEMUR Wrightmedicaltechnologyinc | LZO |
| Sep 7, 2001 | K011836 | MPF ACETABULAR CUP Plus Orthopedics | LZO |
| Apr 18, 2001 | K010839 | CLS VARUS STEM/CLS 135 STEM Sulzer Orthopedics, Inc. | LZO |
| Apr 6, 2001 | K003274 | LPC-PLUS ACETABULAR CUP Plus Orthopedics | LZO |
| Mar 20, 2001 | K010560 | PORTRAIT FEMORAL COMPONENT Biomet, Inc. | LZO |
| Mar 20, 2001 | K003923 | APEX MODULAR ZIRCONIA FEMORAL HEAD Apex Surgical, LLC | LZO |
| Jan 19, 2001 | K003316 | OTI CERAMIC FEMORAL HEAD SYSTEM Osteoimplant Technology, Inc. | LZO |
| Nov 30, 2000 | K003379 | V-40/C-TAPER ADAPTER SLEEVE Howmedica Osteonics Corp. | LZO |
| Nov 28, 2000 | K003391 | OSTEONICS ALUMINA C-TAPER HEAD Howmedica Osteonics Corp. | LZO |
| Nov 24, 2000 | K003413 | ALUMINA V40 HEAD Howmedica Osteonics Corp. | LZO |
| Sep 14, 2000 | K002320 | ACCOLADE C FEMORAL COMPONENT Howmedica Osteonics Corp. | LZO |
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