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 |
|---|---|---|---|
| Mar 8, 2013 | K130128 | TRINITY ACETABULAR SYSTEM Corin Medical | LZO |
| Mar 4, 2013 | K123392 | AVENIR MULLER STEM Zimmer GmbH | LZO |
| Mar 1, 2013 | K123924 | DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS Depuy Orthopaedics | LZO |
| Feb 22, 2013 | K122185 | U-MOTION II ACETABULAR SYSTEM United Orthopedic Corp., TW | LZO |
| Feb 12, 2013 | K123705 | TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS Corin USA | LZO |
| Feb 8, 2013 | K123688 | PROFEMUR TL CLASSIC HIP STEM Wrightmedicaltechnologyinc | LZO |
| Feb 5, 2013 | K123434 | PROFEMUR Z CLASSIC STEMS Wrightmedicaltechnologyinc | LZO |
| Jan 16, 2013 | K121392 | NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE Exactech, Inc. | LZO |
| Nov 21, 2012 | K122305 | CORIN TRINITY-I ACETABULAR SHELL Corin USA | LZO |
| Oct 19, 2012 | K122911 | VERSAFITCUP CC TRIO EXTENSION Medacta International | LZO |
| Oct 12, 2012 | K111981 | TREGOR DUAL MOBILITY ACETABULAR SYSTEM Aston Medical | LZO |
| Sep 28, 2012 | K122641 | MPACT EXTENSION Medacta International | LZO |
| Sep 25, 2012 | K121665 | BENCOX FORET & BENCOX DELTA Corentec Co., Ltd., KR | LZO |
| Sep 14, 2012 | K121439 | METAFIX FEMORAL HIP STEM SIZE 1 Corin USA | LZO |
| Aug 28, 2012 | K122296 | SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING Smith & Nephew, Inc. | LZO |
| Aug 9, 2012 | K121221 | PROFEMUR Z REVISION HIP STEM Wrightmedicaltechnologyinc | LZO |
| Jul 19, 2012 | K120211 | SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING Smith & Nephew, Inc. | LZO |
| Jun 8, 2012 | K121011 | AMISTEM AND QUADRA - LINE EXTENSION Medacta International | LZO |
| May 4, 2012 | K120362 | METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY Corin USA | LZO |
| Apr 18, 2012 | K120531 | VERSAFITCUP CC TRIO-ADDITIONAL LINERS Medacta International | LZO |
| Mar 19, 2012 | K112682 | METHA HIP SYSTEM Aesculap Implant Systems, LLC | LZO |
| Feb 17, 2012 | K113556 | WAGNER CONE PROSTHESIS SYSTEM Zimmer GmbH | LZO |
| Oct 7, 2011 | K112115 | MECTACER BIOLOX(R) DELTA FEMORAL HEADS Medacta International | LZO |
| Sep 23, 2011 | K112463 | UNITED 36MM CERAMIC FEMORAL HEAD, DELTA United Orthopedic Corporation, TW | LZO |
| Sep 21, 2011 | K111936 | ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD Ortho Development | LZO |
| Aug 29, 2011 | K111572 | NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL Serf | LZO |
| Jun 29, 2011 | K111046 | CORIN MINIHIP FEMORAL STEM Corin USA | LZO |
| Jun 27, 2011 | K111193 | APEX ARC HIP STEM Omni Life Science, Inc. | LZO |
| May 3, 2011 | K110087 | CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS Corin USA | LZO |
| Apr 11, 2011 | K110101 | TAPER OXINIUM FEMORAL HEAD Smith & Nephew, Inc. | LZO |
| Mar 10, 2011 | K093736 | DEPUY CORAIL HIP SYSTEM, REVISION STEM DePuy Orthopaedics, Inc. | LZO |
| Feb 28, 2011 | K103120 | CORIN BIOLOX DELTA FEMORAL HEADS Corin USA | LZO |
| Feb 11, 2011 | K103352 | VERSAFITCUP CC TRIO Medacta International | LZO |
| Feb 3, 2011 | K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT Howmedica Osteonics Corp. | LZO |
| Jan 5, 2011 | K101472 | MULTIFIT TOTAL HIP SYSTEM Otis Biotech Co., Ltd., KR | LZO |
| Dec 20, 2010 | K103189 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK Medacta International S.A. | LZO |
| Nov 23, 2010 | K102080 | DEPUY RECLAIM REVISION HIP SYSTEM Depuy(Ireland) | LZO |
| Nov 10, 2010 | K103012 | EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS Exactech, Inc. | LZO |
| Nov 8, 2010 | K102487 | NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 Exactech, Inc. | LZO |
| Jul 30, 2010 | K101296 | ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS Zimmer, Inc. | LZO |
| Jun 22, 2010 | K101451 | APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD Omni Life Science, Inc. | LZO |
| May 18, 2010 | K100008 | CARDO MEDICAL CERAMIC HIP SYSTEM Cardo Medical, Inc. | LZO |
| May 5, 2010 | K100412 | BIOLOX DELTA CERAMIC FEMORAL HEADS Smith & Nephew, Inc. | LZO |
| Apr 28, 2010 | K100866 | PROFEMUR HIP SYSTEM MODULAR NECKS Wrightmedicaltechnologyinc | LZO |
| Apr 15, 2010 | K093991 | SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS Smith & Nephew, Inc. | LZO |
| Apr 7, 2010 | K090845 | APEX ARC HIP STEM Omni Life Science, Inc. | LZO |
| Apr 5, 2010 | K083312 | MINIHIP STEM Corin USA | LZO |
| Feb 4, 2010 | K093846 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS Zimmer, Inc. | LZO |
| Feb 4, 2010 | K082525 | CORIN METAFIX FEMORAL STEM Corin USA | LZO |
| Jan 21, 2010 | K093944 | MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S Medacta International S.A. | LZO |
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