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 2 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | Zimmer GmbH | 2019-08-06 | Special | PDF ↗ |
| K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | 2019-08-06 | Traditional | PDF ↗ |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Corin USA | 2019-07-22 | Traditional | PDF ↗ |
| K191374 | Revival Modular Hip Stem | Corin U.S.A. Limited | 2019-07-22 | Traditional | PDF ↗ |
| K183532 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | 2019-07-18 | Traditional | PDF ↗ |
| K191145 | MasterLoc Extension | Medacta International S.A. | 2019-05-30 | Special | PDF ↗ |
| K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019-05-24 | Traditional | PDF ↗ |
| K181491 | Delta Dual Mobility System | Lima Corporate S.P.A. | 2019-05-09 | Traditional | PDF ↗ |
| K181171 | Zimmer Biomet Ceramic Heads | Zimmer, Inc. | 2019-04-02 | Traditional | PDF ↗ |
| K183365 | Libertas Acetabular Hooded Liner | Maxx Orthopedics, Inc. | 2019-02-22 | Special | PDF ↗ |
| K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups | B-One Ortho, Corp. | 2019-02-14 | Traditional | PDF ↗ |
| K183141 | LINK MP Monoblock Hip Prosthesis | Waldemar Link GmbH & Co. KG | 2019-02-08 | Traditional | PDF ↗ |
| K183136 | Zimmer Segmental System Proximal Femoral Component | Zimmer, Inc. | 2019-01-30 | Special | PDF ↗ |
| K181761 | Zimmer Biomet Select Ceramic Heads | Zimmer, Inc. | 2018-12-26 | Traditional | PDF ↗ |
| K181744 | BI-MENTUM dual mobility system | Serf | 2018-12-11 | Traditional | PDF ↗ |
| K182048 | Avenir Complete Hip System | Zimmer, Inc. | 2018-12-07 | Traditional | PDF ↗ |
| K181693 | SMS Femoral Stem | Medacta International S.A. | 2018-11-28 | Traditional | PDF ↗ |
| K182462 | Exactech Alteon Highly Polished Femoral Stem | Exactech, Inc. | 2018-11-08 | Traditional | PDF ↗ |
| K181254 | Quadra P | Medacta International S.A. | 2018-10-22 | Traditional | PDF ↗ |
| K173960 | DePuy Corail AMT Hip Prosthesis | Depuy France S.A.S. | 2018-09-21 | Traditional | PDF ↗ |
| K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018-09-20 | Traditional | PDF ↗ |
| K181598 | Prime E-CLASS XLPE Liner | Microport Orthopedics, Inc. | 2018-09-14 | Traditional | PDF ↗ |
| K181061 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | 2018-09-07 | Traditional | PDF ↗ |
| K181532 | Exactech Alteon Monobloc Revision Stem | Exactech, Inc. | 2018-09-04 | Special | PDF ↗ |
| K173380 | b-ONE® Total Hip System | B-One Ortho, Corp. | 2018-08-30 | Traditional | PDF ↗ |
| K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018-07-20 | Traditional | PDF ↗ |
| K173776 | BIOLOX delta Option and Extra-long Heads | Microport Orthopedics, Inc. | 2018-07-06 | Traditional | PDF ↗ |
| K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | 2018-05-09 | Special | PDF ↗ |
| K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018-04-26 | Traditional | PDF ↗ |
| K172235 | CoreHip® System | Aesculap Implants Systems, LLC | 2018-03-28 | Traditional | PDF ↗ |
| K173794 | AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared | Medacta International S.A. | 2018-03-14 | Traditional | PDF ↗ |
| K172467 | OMNI ARC Anteverted Neck Hip Stem | Omnilife Science | 2017-12-21 | Traditional | PDF ↗ |
| K173267 | MasterLoc Stem: Lateralized Plus | Medacta International S.A. | 2017-12-07 | Traditional | PDF ↗ |
| K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | 2017-11-29 | Traditional | PDF ↗ |
| K170473 | C2 femoral stem | Lima Corporate S.P.A. | 2017-11-08 | Traditional | PDF ↗ |
| K170359 | Trinity Dual Mobility System | Corin U.S.A. Limited | 2017-10-31 | Traditional | PDF ↗ |
| K170089 | U-Motion II Acetabular System Additional sizes | United Orthopedic Corporation | 2017-10-06 | Traditional | PDF ↗ |
| K163577 | Ecofit® Hip System | Implantcast GmbH | 2017-09-25 | Traditional | PDF ↗ |
| K171181 | PROCOTYL® PRIME E-CLASS XLPE Liner | Microport Orthopedics, Inc. | 2017-08-28 | Traditional | PDF ↗ |
| K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017-08-25 | Traditional | PDF ↗ |
| K171156 | OMNI Anseris Hip Stem | Omnilife Science | 2017-08-17 | Traditional | PDF ↗ |
| K170845 | MiniMAX | Medacta International S.A. | 2017-08-08 | Traditional | PDF ↗ |
| K162942 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | 2017-06-20 | Traditional | PDF ↗ |
| K163585 | Responsive Orthopedics Total Hip Arthroplasty System | Responsive Orthopedics, LLC | 2017-06-02 | Traditional | PDF ↗ |
| K161635 | AMIStem-H Proximal Coating | Medacta International S.A. | 2017-03-31 | Traditional | PDF ↗ |
| K161840 | LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated | Waldemar Link GmbH & Co. KG | 2017-03-16 | Traditional | PDF ↗ |
| K161226 | Revision Femoral Stem | Lima Corporate S.P.A. | 2017-02-10 | Traditional | PDF ↗ |
| K160895 | Initia Total Hip System & BIOCERAM AZUL(R) HEAD | Kyocera Medical Corporation | 2016-11-01 | Traditional | PDF ↗ |
| K161830 | Zimmer M/L Taper Hip Prosthesis | Zimmer, Inc. | 2016-10-26 | Special | PDF ↗ |
| K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | 2016-07-08 | Special | PDF ↗ |
| K152893 | Corin Optimized Positioning System (OPS) | Corin USA | 2016-06-03 | Traditional | PDF ↗ |
| K160289 | MasterLoc Stem | Medacta International | 2016-05-20 | Traditional | PDF ↗ |
| K152903 | REVIVAL(TM) Modular Revision Hip Stem | Corin USA | 2016-04-29 | Traditional | PDF ↗ |
| K152530 | UCP Stem | United Orthopedic Corporation | 2016-03-14 | Traditional | PDF ↗ |
| K152919 | OMNI Skirted Heads | Omni Life Science, Inc. | 2016-03-10 | Traditional | PDF ↗ |
| K151307 | ICONACY(TM) I-Hip (TM) | Iconacy Orthopedic Implants, LLC | 2016-02-26 | Traditional | PDF ↗ |
| K153381 | Corin Metafix Hip Stem | Corin U.S.A. Limited | 2016-01-21 | Traditional | PDF ↗ |
| K151739 | Revision Femoral Stem | Lima Corporate S.P.A. | 2015-11-23 | Traditional | PDF ↗ |
| K151531 | MasterLoc Stem | Medacta International | 2015-10-30 | Traditional | PDF ↗ |
| K150576 | TGM Biolox delta Ceramic Heads | Tgm Medical, Inc. | 2015-09-09 | Traditional | PDF ↗ |
| K151902 | REDAPT¿ Revision Femoral System | Smith & Nephew, Inc. | 2015-09-03 | Abbreviated | PDF ↗ |
| K150066 | Exactech Alteon Monobloc Revision Stem | Exactech, Inc. | 2015-07-20 | Traditional | PDF ↗ |
| K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA | Smith & Nephew, Inc. | 2015-04-20 | Traditional | PDF ↗ |
| K150133 | PROFEMUR Preserve Size 1-3 Hip Stems | Microport Orthopedics, Inc. | 2015-04-20 | Traditional | PDF ↗ |
| K150302 | PROFEMUR Preserve Classic Stem | Microport Orthopedics, Inc. | 2015-04-10 | Traditional | PDF ↗ |
| K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA | Smith & Nephew, Inc. | 2015-03-24 | Traditional | PDF ↗ |
| K150062 | Excia Total Hip System | Aesculap Implant Systems, LLC | 2015-02-09 | Special | PDF ↗ |
| K143509 | MasterSL femoral stem | Lima Corporate S.P.A. | 2015-01-27 | Special | PDF ↗ |
| K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular Cup | Serf | 2015-01-15 | Traditional | PDF ↗ |
| K143407 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2014-12-23 | Special | PDF ↗ |
| K141377 | BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD | Merete Medical GmbH | 2014-11-21 | Traditional | PDF ↗ |
| K142187 | LINK MP RECONSTRUCTION PROSTHESIS | Waldemar Link GmbH & Co. KG | 2014-11-06 | Traditional | PDF ↗ |
| K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS | Microport Orthopedics, Inc. | 2014-09-12 | Traditional | PDF ↗ |
| K141821 | ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET | Exactech, Inc. | 2014-08-28 | Special | PDF ↗ |
| K141653 | BIOLOX DELTA CERAMIC OPTION HEADS | Biomet, Inc. | 2014-08-18 | Traditional | PDF ↗ |
| K141327 | MINIMA S SYSTEM | Lima Corporate S.P.A. | 2014-08-06 | Traditional | PDF ↗ |
| K140915 | EXCIA TOTAL HIP SYSTEM | Aesculap Implant Systems, LLC | 2014-07-21 | Special | PDF ↗ |
| K140674 | EXACTECH TAPERED WEDGE FEMORAL STEM | Exactech, Inc. | 2014-06-30 | Traditional | PDF ↗ |
| K140975 | MASTERSL FEMORAL STEM | Lima Corporate S.P.A. | 2014-06-10 | Traditional | PDF ↗ |
| K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS | Microport Orthopedics, Inc. | 2014-05-30 | Traditional | PDF ↗ |
| K140043 | DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD | Microport Orthopedics, Inc. | 2014-04-03 | Traditional | PDF ↗ |
| K133381 | OMNI ARC MONOBLOCK HIP STEM | Omnilife Science | 2014-03-13 | Traditional | PDF ↗ |
| K131952 | CORIN METAFIX HIP STEM | Corin USA | 2013-12-16 | Traditional | PDF ↗ |
| K131986 | CORIN MINIHIP STEM | Corin USA | 2013-12-16 | Traditional | PDF ↗ |
| K131518 | MECTACER BIOLOX OPTION HEADS | Medacta International | 2013-11-04 | Traditional | PDF ↗ |
| K132435 | SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS | Smith & Nephew, Inc. | 2013-10-22 | Traditional | PDF ↗ |
| K131684 | BIOLOX(R) DELTA CERAMIC HEADS | Biomet, Inc. | 2013-10-10 | Traditional | PDF ↗ |
| K130728 | POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA | Smith & Nephew, Inc. | 2013-10-10 | Traditional | PDF ↗ |
| K131458 | MPACT DM LINER CONVERTER | Medacta International | 2013-10-01 | Traditional | PDF ↗ |
| K131647 | TRINITY ACETABULAR SYSTEM | Corin USA | 2013-09-27 | Traditional | PDF ↗ |
| K132455 | U-MOTION II PS+ CUP | United Orthopedic Corp. | 2013-09-03 | Special | PDF ↗ |
| K131884 | AVENIR CEMENTED HIP STEM | Zimmer GmbH | 2013-08-22 | Traditional | PDF ↗ |
| K130376 | DYNASTY ACETABULAR SYSTEM WITH CERAMIC | Wrightmedicaltechnologyinc | 2013-07-03 | Traditional | PDF ↗ |
| K130343 | CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS | Corin USA | 2013-05-28 | Traditional | PDF ↗ |
| K123619 | INTRABLOCK BIOBALL HIP SYSTEM (IBS) | Merete Medical GmbH | 2013-05-24 | Traditional | PDF ↗ |
| K130634 | CORIN METAFIX HIP STEM | Corin USA | 2013-05-24 | Traditional | PDF ↗ |
| K130984 | PROFEMUR RENAISSANCE CLASSIC HIP STEM | Wrightmedicaltechnologyinc | 2013-05-24 | Special | PDF ↗ |
| K130899 | BIOLOX DELTA CERAMIC FEMORAL HEADS | Zimmer GmbH | 2013-05-01 | Special | PDF ↗ |
| K130167 | PROFEMUR XM DISTAL CENTRALIZER | Wrightmedicaltechnologyinc | 2013-04-19 | Traditional | PDF ↗ |
| K123782 | PARAGON HIP SYSTEM | Global Manufacturing Technology | 2013-03-14 | Traditional | PDF ↗ |
Product code LZO · Class II · Orthopedic. Data: openFDA.