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 |
|---|---|---|---|
| Jun 3, 2016 | K152893 | Corin Optimized Positioning System (OPS) Corin USA | LZO |
| May 20, 2016 | K160289 | MasterLoc Stem Medacta International, CH | LZO |
| Apr 29, 2016 | K152903 | REVIVAL(TM) Modular Revision Hip Stem Corin USA | LZO |
| Mar 14, 2016 | K152530 | UCP Stem United Orthopedic Corporation, TW | LZO |
| Mar 10, 2016 | K152919 | OMNI Skirted Heads Omni Life Science, Inc. | LZO |
| Feb 26, 2016 | K151307 | ICONACY(TM) I-Hip (TM) Iconacy Orthopedic Implants, LLC | LZO |
| Jan 21, 2016 | K153381 | Corin Metafix Hip Stem Corin U.S.A. Limited | LZO |
| Nov 23, 2015 | K151739 | Revision Femoral Stem Lima Corporate S.P.A., IT | LZO |
| Oct 30, 2015 | K151531 | MasterLoc Stem Medacta International, CH | LZO |
| Sep 9, 2015 | K150576 | TGM Biolox delta Ceramic Heads Tgm Medical, Inc. | LZO |
| Sep 3, 2015 | K151902 | REDAPT¿ Revision Femoral System Smith & Nephew, Inc. | LZO |
| Jul 20, 2015 | K150066 | Exactech Alteon Monobloc Revision Stem Exactech, Inc. | LZO |
| Apr 20, 2015 | K150133 | PROFEMUR Preserve Size 1-3 Hip Stems Microport Orthopedics, Inc. | LZO |
| Apr 20, 2015 | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA Smith & Nephew, Inc. | LZO |
| Apr 10, 2015 | K150302 | PROFEMUR Preserve Classic Stem Microport Orthopedics, Inc. | LZO |
| Mar 24, 2015 | K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA Smith & Nephew, Inc. | LZO |
| Feb 9, 2015 | K150062 | Excia Total Hip System Aesculap Implant Systems, LLC | LZO |
| Jan 27, 2015 | K143509 | MasterSL femoral stem Lima Corporate S.P.A., IT | LZO |
| Jan 15, 2015 | K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular Cup Serf, FR | LZO |
| Dec 23, 2014 | K143407 | Klassic HD Hip System Total Joint Othopedics, Inc. | LZO |
| Nov 21, 2014 | K141377 | BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD Merete Medical GmbH, DE | LZO |
| Nov 6, 2014 | K142187 | LINK MP RECONSTRUCTION PROSTHESIS Waldemar Link GmbH & Co. KG, DE | LZO |
| Sep 12, 2014 | K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS Microport Orthopedics, Inc. | LZO |
| Aug 28, 2014 | K141821 | ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET Exactech, Inc. | LZO |
| Aug 18, 2014 | K141653 | BIOLOX DELTA CERAMIC OPTION HEADS Biomet, Inc. | LZO |
| Aug 6, 2014 | K141327 | MINIMA S SYSTEM Lima Corporate S.P.A. | LZO |
| Jul 21, 2014 | K140915 | EXCIA TOTAL HIP SYSTEM Aesculap Implant Systems, LLC | LZO |
| Jun 30, 2014 | K140674 | EXACTECH TAPERED WEDGE FEMORAL STEM Exactech, Inc. | LZO |
| Jun 10, 2014 | K140975 | MASTERSL FEMORAL STEM Lima Corporate S.P.A. | LZO |
| May 30, 2014 | K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS Microport Orthopedics, Inc. | LZO |
| Apr 3, 2014 | K140043 | DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD Microport Orthopedics, Inc. | LZO |
| Mar 13, 2014 | K133381 | OMNI ARC MONOBLOCK HIP STEM Omnilife Science | LZO |
| Dec 16, 2013 | K131986 | CORIN MINIHIP STEM Corin USA | LZO |
| Dec 16, 2013 | K131952 | CORIN METAFIX HIP STEM Corin USA | LZO |
| Nov 4, 2013 | K131518 | MECTACER BIOLOX OPTION HEADS Medacta International | LZO |
| Oct 22, 2013 | K132435 | SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS Smith & Nephew, Inc. | LZO |
| Oct 10, 2013 | K131684 | BIOLOX(R) DELTA CERAMIC HEADS Biomet, Inc. | LZO |
| Oct 10, 2013 | K130728 | POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA Smith & Nephew, Inc. | LZO |
| Oct 1, 2013 | K131458 | MPACT DM LINER CONVERTER Medacta International | LZO |
| Sep 27, 2013 | K131647 | TRINITY ACETABULAR SYSTEM Corin USA | LZO |
| Sep 3, 2013 | K132455 | U-MOTION II PS+ CUP United Orthopedic Corp., TW | LZO |
| Aug 22, 2013 | K131884 | AVENIR CEMENTED HIP STEM Zimmer GmbH | LZO |
| Jul 3, 2013 | K130376 | DYNASTY ACETABULAR SYSTEM WITH CERAMIC Wrightmedicaltechnologyinc | LZO |
| May 28, 2013 | K130343 | CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS Corin USA | LZO |
| May 24, 2013 | K130984 | PROFEMUR RENAISSANCE CLASSIC HIP STEM Wrightmedicaltechnologyinc | LZO |
| May 24, 2013 | K130634 | CORIN METAFIX HIP STEM Corin USA | LZO |
| May 24, 2013 | K123619 | INTRABLOCK BIOBALL HIP SYSTEM (IBS) Merete Medical GmbH, DE | LZO |
| May 1, 2013 | K130899 | BIOLOX DELTA CERAMIC FEMORAL HEADS Zimmer GmbH | LZO |
| Apr 19, 2013 | K130167 | PROFEMUR XM DISTAL CENTRALIZER Wrightmedicaltechnologyinc | LZO |
| Mar 14, 2013 | K123782 | PARAGON HIP SYSTEM Global Manufacturing Technology | LZO |
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