FDA Product Code
FDA Product Code LZO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3353
510(k) Clearances — 535 records · page 3 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130128 | TRINITY ACETABULAR SYSTEM | Corin Medical | 2013-03-08 | Special | PDF ↗ |
| K123392 | AVENIR MULLER STEM | Zimmer GmbH | 2013-03-04 | Traditional | PDF ↗ |
| K123924 | DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS | Depuy Orthopaedics | 2013-03-01 | Traditional | PDF ↗ |
| K122185 | U-MOTION II ACETABULAR SYSTEM | United Orthopedic Corp. | 2013-02-22 | Traditional | PDF ↗ |
| K123705 | TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS | Corin USA | 2013-02-12 | Traditional | PDF ↗ |
| K123688 | PROFEMUR TL CLASSIC HIP STEM | Wrightmedicaltechnologyinc | 2013-02-08 | Special | PDF ↗ |
| K123434 | PROFEMUR Z CLASSIC STEMS | Wrightmedicaltechnologyinc | 2013-02-05 | Special | PDF ↗ |
| K121392 | NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE | Exactech, Inc. | 2013-01-16 | Special | PDF ↗ |
| K122305 | CORIN TRINITY-I ACETABULAR SHELL | Corin USA | 2012-11-21 | Traditional | PDF ↗ |
| K122911 | VERSAFITCUP CC TRIO EXTENSION | Medacta International | 2012-10-19 | Special | PDF ↗ |
| K111981 | TREGOR DUAL MOBILITY ACETABULAR SYSTEM | Aston Medical | 2012-10-12 | Traditional | PDF ↗ |
| K122641 | MPACT EXTENSION | Medacta International | 2012-09-28 | Special | PDF ↗ |
| K121665 | BENCOX FORET & BENCOX DELTA | Corentec Co., Ltd. | 2012-09-25 | Traditional | PDF ↗ |
| K121439 | METAFIX FEMORAL HIP STEM SIZE 1 | Corin USA | 2012-09-14 | Traditional | PDF ↗ |
| K122296 | SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING | Smith & Nephew, Inc. | 2012-08-28 | Special | PDF ↗ |
| K121221 | PROFEMUR Z REVISION HIP STEM | Wrightmedicaltechnologyinc | 2012-08-09 | Special | PDF ↗ |
| K120211 | SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING | Smith & Nephew, Inc. | 2012-07-19 | Traditional | PDF ↗ |
| K121011 | AMISTEM AND QUADRA - LINE EXTENSION | Medacta International | 2012-06-08 | Special | PDF ↗ |
| K120362 | METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY | Corin USA | 2012-05-04 | Traditional | PDF ↗ |
| K120531 | VERSAFITCUP CC TRIO-ADDITIONAL LINERS | Medacta International | 2012-04-18 | Special | PDF ↗ |
| K112682 | METHA HIP SYSTEM | Aesculap Implant Systems, LLC | 2012-03-19 | Traditional | PDF ↗ |
| K113556 | WAGNER CONE PROSTHESIS SYSTEM | Zimmer GmbH | 2012-02-17 | Special | PDF ↗ |
| K112115 | MECTACER BIOLOX(R) DELTA FEMORAL HEADS | Medacta International | 2011-10-07 | Special | PDF ↗ |
| K112463 | UNITED 36MM CERAMIC FEMORAL HEAD, DELTA | United Orthopedic Corporation | 2011-09-23 | Special | PDF ↗ |
| K111936 | ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD | Ortho Development | 2011-09-21 | Special | PDF ↗ |
| K111572 | NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL | Serf | 2011-08-29 | Traditional | PDF ↗ |
| K111046 | CORIN MINIHIP FEMORAL STEM | Corin USA | 2011-06-29 | Special | PDF ↗ |
| K111193 | APEX ARC HIP STEM | Omni Life Science, Inc. | 2011-06-27 | Special | PDF ↗ |
| K110087 | CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS | Corin USA | 2011-05-03 | Traditional | PDF ↗ |
| K110101 | TAPER OXINIUM FEMORAL HEAD | Smith & Nephew, Inc. | 2011-04-11 | Traditional | PDF ↗ |
| K093736 | DEPUY CORAIL HIP SYSTEM, REVISION STEM | DePuy Orthopaedics, Inc. | 2011-03-10 | Traditional | PDF ↗ |
| K103120 | CORIN BIOLOX DELTA FEMORAL HEADS | Corin USA | 2011-02-28 | Traditional | PDF ↗ |
| K103352 | VERSAFITCUP CC TRIO | Medacta International | 2011-02-11 | Traditional | PDF ↗ |
| K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT | Howmedica Osteonics Corp. | 2011-02-03 | Traditional | PDF ↗ |
| K101472 | MULTIFIT TOTAL HIP SYSTEM | Otis Biotech Co., Ltd. | 2011-01-05 | Abbreviated | PDF ↗ |
| K103189 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK | Medacta International S.A. | 2010-12-20 | Special | PDF ↗ |
| K102080 | DEPUY RECLAIM REVISION HIP SYSTEM | Depuy(Ireland) | 2010-11-23 | Traditional | PDF ↗ |
| K103012 | EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS | Exactech, Inc. | 2010-11-10 | Special | PDF ↗ |
| K102487 | NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 | Exactech, Inc. | 2010-11-08 | Special | PDF ↗ |
| K101296 | ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS | Zimmer, Inc. | 2010-07-30 | Traditional | PDF ↗ |
| K101451 | APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD | Omni Life Science, Inc. | 2010-06-22 | Special | PDF ↗ |
| K100008 | CARDO MEDICAL CERAMIC HIP SYSTEM | Cardo Medical, Inc. | 2010-05-18 | Traditional | PDF ↗ |
| K100412 | BIOLOX DELTA CERAMIC FEMORAL HEADS | Smith & Nephew, Inc. | 2010-05-05 | Traditional | PDF ↗ |
| K100866 | PROFEMUR HIP SYSTEM MODULAR NECKS | Wrightmedicaltechnologyinc | 2010-04-28 | Special | PDF ↗ |
| K093991 | SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS | Smith & Nephew, Inc. | 2010-04-15 | Traditional | PDF ↗ |
| K090845 | APEX ARC HIP STEM | Omni Life Science, Inc. | 2010-04-07 | Traditional | PDF ↗ |
| K083312 | MINIHIP STEM | Corin USA | 2010-04-05 | Traditional | PDF ↗ |
| K093846 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS | Zimmer, Inc. | 2010-02-04 | Special | PDF ↗ |
| K082525 | CORIN METAFIX FEMORAL STEM | Corin USA | 2010-02-04 | Traditional | PDF ↗ |
| K093944 | MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S | Medacta International S.A. | 2010-01-21 | Special | PDF ↗ |
| K093549 | 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM | Biomet Manufacturing Corp | 2009-12-16 | Special | PDF ↗ |
| K090299 | BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS | Aesculap Implant Systems | 2009-04-24 | Special | PDF ↗ |
| K083762 | BIOLOX DELTA CERAMIC FEMORAL HEADS | Smith & Nephew, Inc. | 2009-03-11 | Special | PDF ↗ |
| K083558 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C | Medacta International S.A. | 2009-03-06 | Traditional | PDF ↗ |
| K082371 | SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM | Smith & Nephew, Inc. | 2009-02-09 | Traditional | PDF ↗ |
| K083495 | MODIFICATION TO: METHA HIP SYSTEM | Aesculap Implant Systems, Inc. | 2009-01-15 | Special | PDF ↗ |
| K082996 | BIOLOX DELTA OPTION CERAMIC HEADS | Biomet, Inc. | 2009-01-15 | Special | PDF ↗ |
| K083392 | NOVATION 12/14 CEMENTED FEMORAL STEMS | Exactech, Inc. | 2008-12-17 | Special | PDF ↗ |
| K082844 | BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE | Encore Medical L.P. | 2008-11-25 | Special | PDF ↗ |
| K082991 | BIOLOX DELTA CERAMIC FEMORAL HEAD | Aesculap Implant Systems, Inc. | 2008-11-20 | Special | PDF ↗ |
| K082398 | ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS | Encore Medical L.P. | 2008-10-15 | Special | PDF ↗ |
| K081860 | ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS | Zimmer, Inc. | 2008-09-26 | Traditional | PDF ↗ |
| K081973 | METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM | Aesculap Implant Systems, Inc. | 2008-08-07 | Special | PDF ↗ |
| K072852 | SL-PLUS STANDARD AND LATERAL HIP STEMS | Smith & Nephew, Inc. | 2008-06-09 | Traditional | PDF ↗ |
| K073567 | BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES | Zimmer GmbH | 2008-03-13 | Traditional | PDF ↗ |
| K073570 | DEPUY TRI-LOCK BONE PRESERVATION STEM | DePuy Orthopaedics, Inc. | 2008-02-21 | Special | PDF ↗ |
| K073337 | MECTACER BIOLOX FORTE-FEMORAL HEADS | Medacta International S.A. | 2008-02-13 | Traditional | PDF ↗ |
| K072656 | DYNASTY CERAMIC FEMORAL HEAD | Wrightmedicaltechnologyinc | 2008-02-06 | Special | PDF ↗ |
| K073102 | BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS | Biomet Manufacturing Corp | 2007-11-27 | Special | PDF ↗ |
| K071535 | BIOLOX DELTA CERAMIC FEMORAL HEAD | Zimmer, Inc. | 2007-11-19 | Traditional | PDF ↗ |
| K071830 | DEPUY DELTA TS CERAMIC FEMORAL HEADS | DePuy Orthopaedics, Inc. | 2007-09-28 | Traditional | PDF ↗ |
| K071082 | STRYKER MODULAR HIP SYSTEM | Howmedica Osteonics Corp. | 2007-09-13 | Traditional | PDF ↗ |
| K070554 | DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS | DePuy Orthopaedics, Inc. | 2007-09-11 | Special | PDF ↗ |
| K070928 | CERAMIC BALL HEADS, 28, 32 AND 36 MM | Plus Orthopedics AG | 2007-08-01 | Traditional | PDF ↗ |
| K070885 | UNIVERSAL TAPER DELTA FEMORAL HEAD | Howmedica Osteonics Corp. | 2007-05-16 | Traditional | PDF ↗ |
| K070479 | EXACTECH NOVATION CROWN CUP AND LINERS | Exactech, Inc. | 2007-03-15 | Special | PDF ↗ |
| K063816 | PCA ALUMINA FEMORAL HEADS | Stryker Orthopaedics | 2007-02-02 | Traditional | PDF ↗ |
| K063616 | TRIDENT II ACETABULAR SYSTEM | Howmedica Osteonics Corp. | 2006-12-20 | Special | PDF ↗ |
| K062997 | ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS | Biomet Manufacturing Corp | 2006-12-08 | Traditional | PDF ↗ |
| K062748 | MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD | DePuy Orthopaedics, Inc. | 2006-11-30 | Special | PDF ↗ |
| K063279 | NOVATION SPLINED RDD FEMORAL STEMS | Exactech, Inc. | 2006-11-29 | Special | PDF ↗ |
| K062684 | EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD | Aesculap, Inc. | 2006-11-22 | Special | PDF ↗ |
| K061564 | PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD | Portland Orthopaedics Pty. , Ltd. | 2006-09-01 | Traditional | PDF ↗ |
| K061066 | SYNERGY HIP SYSTEM | Smith & Nephew, Inc. | 2006-07-14 | Traditional | PDF ↗ |
| K053246 | PATIENT MATCHED HIP STEM | Smith & Nephew, Inc. | 2006-07-12 | Abbreviated | PDF ↗ |
| K061312 | 36MM BIOLOX DELTA CERAMIC HEADS | Biomet, Inc. | 2006-06-06 | Special | PDF ↗ |
| K060918 | EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD | Aesculap, Inc. | 2006-05-26 | Special | PDF ↗ |
| K051223 | HIPSTAR FEMORAL STEM | Stryker Orthopaedics | 2006-05-10 | Traditional | PDF ↗ |
| K060577 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS | Ortho Development Corp. | 2006-04-28 | Traditional | PDF ↗ |
| K053587 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS | Ortho Development Corp. | 2006-03-17 | Traditional | PDF ↗ |
| K060107 | MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS | Exactech, Inc. | 2006-02-06 | Special | PDF ↗ |
| 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. | 2005-12-27 | Special | PDF ↗ |
| K052275 | SMITH & NEPHEW PLATFORM HIP STEM | Smith & Nephew, Inc. | 2005-12-07 | Abbreviated | PDF ↗ |
| K051858 | ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM | Exactech, Inc. | 2005-12-01 | Special | PDF ↗ |
| K050398 | EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS | Exactech, Inc. | 2005-11-18 | Special | PDF ↗ |
| K052718 | V40 BIOLOX DELTA CERAMIC FEMORAL HEADS | Howmedica Osteonics Corp. | 2005-10-27 | Special | PDF ↗ |
| K052542 | ACCOLADE RPS HIP STEM | Stryker Orthopaedics | 2005-09-27 | Special | PDF ↗ |
| K051741 | ACCOLADE HFX FEMORAL STEM | Stryker Orthopaedics | 2005-09-26 | Traditional | PDF ↗ |
| K052237 | SC CERAMIC BALL HEADS | Orthopedic Alliance, LLC | 2005-09-06 | Special | PDF ↗ |
| K051738 | SECUR-FIT MAX AND PLUS MAX HIP STEMS | Howmedica Osteonics Corp. | 2005-07-19 | Special | PDF ↗ |
Product code LZO · Class II · Orthopedic. Data: openFDA.