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 |
|---|---|---|---|
| Dec 16, 2009 | K093549 | 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM Biomet Manufacturing Corp | LZO |
| Apr 24, 2009 | K090299 | BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS Aesculap Implant Systems | LZO |
| Mar 11, 2009 | K083762 | BIOLOX DELTA CERAMIC FEMORAL HEADS Smith & Nephew, Inc. | LZO |
| Mar 6, 2009 | K083558 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C Medacta International S.A. | LZO |
| Feb 9, 2009 | K082371 | SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM Smith & Nephew, Inc. | LZO |
| Jan 15, 2009 | K083495 | MODIFICATION TO: METHA HIP SYSTEM Aesculap Implant Systems, Inc. | LZO |
| Jan 15, 2009 | K082996 | BIOLOX DELTA OPTION CERAMIC HEADS Biomet, Inc. | LZO |
| Dec 17, 2008 | K083392 | NOVATION 12/14 CEMENTED FEMORAL STEMS Exactech, Inc. | LZO |
| Nov 25, 2008 | K082844 | BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE Encore Medical L.P. | LZO |
| Nov 20, 2008 | K082991 | BIOLOX DELTA CERAMIC FEMORAL HEAD Aesculap Implant Systems, Inc. | LZO |
| Oct 15, 2008 | K082398 | ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS Encore Medical L.P. | LZO |
| Sep 26, 2008 | K081860 | ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS Zimmer, Inc. | LZO |
| Aug 7, 2008 | K081973 | METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM Aesculap Implant Systems, Inc. | LZO |
| Jun 9, 2008 | K072852 | SL-PLUS STANDARD AND LATERAL HIP STEMS Smith & Nephew, Inc. | LZO |
| Mar 13, 2008 | K073567 | BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES Zimmer GmbH | LZO |
| Feb 21, 2008 | K073570 | DEPUY TRI-LOCK BONE PRESERVATION STEM DePuy Orthopaedics, Inc. | LZO |
| Feb 13, 2008 | K073337 | MECTACER BIOLOX FORTE-FEMORAL HEADS Medacta International S.A. | LZO |
| Feb 6, 2008 | K072656 | DYNASTY CERAMIC FEMORAL HEAD Wrightmedicaltechnologyinc | LZO |
| Nov 27, 2007 | K073102 | BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS Biomet Manufacturing Corp | LZO |
| Nov 19, 2007 | K071535 | BIOLOX DELTA CERAMIC FEMORAL HEAD Zimmer, Inc. | LZO |
| Sep 28, 2007 | K071830 | DEPUY DELTA TS CERAMIC FEMORAL HEADS DePuy Orthopaedics, Inc. | LZO |
| Sep 13, 2007 | K071082 | STRYKER MODULAR HIP SYSTEM Howmedica Osteonics Corp. | LZO |
| Sep 11, 2007 | K070554 | DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS DePuy Orthopaedics, Inc. | LZO |
| Aug 1, 2007 | K070928 | CERAMIC BALL HEADS, 28, 32 AND 36 MM Plus Orthopedics AG | LZO |
| May 16, 2007 | K070885 | UNIVERSAL TAPER DELTA FEMORAL HEAD Howmedica Osteonics Corp. | LZO |
| Mar 15, 2007 | K070479 | EXACTECH NOVATION CROWN CUP AND LINERS Exactech, Inc. | LZO |
| Feb 2, 2007 | K063816 | PCA ALUMINA FEMORAL HEADS Stryker Orthopaedics | LZO |
| Dec 20, 2006 | K063616 | TRIDENT II ACETABULAR SYSTEM Howmedica Osteonics Corp. | LZO |
| Dec 8, 2006 | K062997 | ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS Biomet Manufacturing Corp | LZO |
| Nov 30, 2006 | K062748 | MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD DePuy Orthopaedics, Inc. | LZO |
| Nov 29, 2006 | K063279 | NOVATION SPLINED RDD FEMORAL STEMS Exactech, Inc. | LZO |
| Nov 22, 2006 | K062684 | EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD Aesculap, Inc. | LZO |
| Sep 1, 2006 | K061564 | PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD Portland Orthopaedics Pty. , Ltd. | LZO |
| Jul 14, 2006 | K061066 | SYNERGY HIP SYSTEM Smith & Nephew, Inc. | LZO |
| Jul 12, 2006 | K053246 | PATIENT MATCHED HIP STEM Smith & Nephew, Inc. | LZO |
| Jun 6, 2006 | K061312 | 36MM BIOLOX DELTA CERAMIC HEADS Biomet, Inc. | LZO |
| May 26, 2006 | K060918 | EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD Aesculap, Inc. | LZO |
| May 10, 2006 | K051223 | HIPSTAR FEMORAL STEM Stryker Orthopaedics | LZO |
| Apr 28, 2006 | K060577 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS Ortho Development Corp. | LZO |
| Mar 17, 2006 | K053587 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS Ortho Development Corp. | LZO |
| Feb 6, 2006 | K060107 | MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS Exactech, Inc. | LZO |
| Dec 27, 2005 | K052787 | ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) Exactech, Inc. | LZO |
| Dec 7, 2005 | K052275 | SMITH & NEPHEW PLATFORM HIP STEM Smith & Nephew, Inc. | LZO |
| Dec 1, 2005 | K051858 | ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM Exactech, Inc. | LZO |
| Nov 18, 2005 | K050398 | EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS Exactech, Inc. | LZO |
| Oct 27, 2005 | K052718 | V40 BIOLOX DELTA CERAMIC FEMORAL HEADS Howmedica Osteonics Corp. | LZO |
| Sep 27, 2005 | K052542 | ACCOLADE RPS HIP STEM Stryker Orthopaedics | LZO |
| Sep 26, 2005 | K051741 | ACCOLADE HFX FEMORAL STEM Stryker Orthopaedics | LZO |
| Sep 6, 2005 | K052237 | SC CERAMIC BALL HEADS Orthopedic Alliance, LLC | LZO |
| Jul 19, 2005 | K051738 | SECUR-FIT MAX AND PLUS MAX HIP STEMS Howmedica Osteonics Corp. | LZO |
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