LZO · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Orthopedic · 21 CFR 888.3353 · Class 2
Overview
| Product Code | LZO |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Regulation | 21 CFR 888.3353 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
Classification Rationale
Class II.
Cleared Devices (529)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260037 | implantcast Packaging System Update | Implantcast GmbH | Mar 30, 2026 | SESE |
| K252401 | implaFit® short stems | Implantcast GmbH | Mar 12, 2026 | SESE |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | Jan 15, 2026 | SESE |
| K250450 | Coated hip implants | Medacta International S.A. | Sep 19, 2025 | SESE |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | Aug 7, 2025 | SESE |
| K251906 | Z1 Hip System | Zimmer, Inc. | Jul 18, 2025 | SESE |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | May 23, 2025 | SESE |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | May 16, 2025 | SESE |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | May 15, 2025 | SESE |
| K243043 | Origin Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | May 2, 2025 | SESE |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | Apr 18, 2025 | SESE |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | Mar 28, 2025 | SESE |
| K243029 | Origin TT Stem | Signature Orthopaedics Pty, Ltd. | Mar 11, 2025 | SESE |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. | Mar 6, 2025 | SESE |
| K243809 | Biolox® Delta Revision heads | Limacorporate | Mar 4, 2025 | SESE |
| K241483 | ceramys femoral head system | Encore Medical L.P. | Feb 7, 2025 | SESE |
| K243466 | Conformity Stem Extension Line, #0 | United Orthopedic Corporation | Jan 6, 2025 | SESE |
| K243444 | BIOCERAM AZUL® HEAD | Kyocera Corporation | Dec 5, 2024 | SESE |
| K240528 | b-ONE® Total Hip System | B-One Ortho, Corp. | Nov 15, 2024 | SESE |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | Implantcast GmbH | Oct 24, 2024 | SESE |
| K242249 | Conformity Stem Extension Line | United Orthopedic Corporation | Aug 30, 2024 | SESE |
| K241241 | Z1 Cemented Hip System | Orchard Medical Development, LLC | Aug 27, 2024 | SESE |
| K240381 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | Jun 27, 2024 | SESE |
| K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | Jun 3, 2024 | SESE |
| K234025 | 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Apr 24, 2024 | SESE |
| K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | Apr 12, 2024 | SESE |
| K233724 | 28mm/38D MDM X3 Insert for MDM Liner | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Mar 11, 2024 | SESE |
| K233476 | Z1 Hip System | Orchard Medical Development | Feb 8, 2024 | SESE |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | Dec 22, 2023 | SESE |
| K232371 | Actinia® hip stems | Implantcast GmbH | Oct 19, 2023 | SESE |
| K233233 | EMPHASYS Femoral Stems | Depuy Ireland UC | Oct 11, 2023 | SESE |
| K231925 | MINIMA S System | Lima Corporate S.P.A. | Jul 11, 2023 | SESE |
| K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | Jun 20, 2023 | SESE |
| K231109 | Xerxes Hip Stem | Xerxes Arthopedix, LLC | Jun 15, 2023 | SESE |
| K221323 | Exactech® Alteon® Short Tapered Wedge | Exactech, Inc. | May 19, 2023 | SESE |
| K223828 | BENCOX Delta Option Heads | Corentec Co., Ltd. | Mar 16, 2023 | SESE |
| K222296 | ARTICUL/EZE Ceramic Heads | Depuy Ireland UC | Jan 6, 2023 | SESE |
| K221149 | U-Motion II Acetabular System-Extension line | United Orthopedic Corporation | Jan 5, 2023 | SESE |
| K221462 | DePuy Reclaim Monobloc Revision Femoral Stem | Depuy Ireland UC | Oct 21, 2022 | SESE |
| K220483 | Platform® Acetabular System | Total Joint Orthopedics, Inc. | Sep 23, 2022 | SESE |
| K213770 | SP-CL Hip Stem and LCU Hip System | Waldemar Link GmbH & Co. KG | Sep 13, 2022 | SESE |
| K210678 | implaFit® hip stems | Implantcast GmbH | Aug 17, 2022 | SESE |
| K211891 | DM Converter - TiN coated | Medacta International S.A. | Jul 22, 2022 | SESE |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | Waldemar Link GmbH & Co. KG | Jun 3, 2022 | SESE |
| K212327 | M-Vizion Monobloc | Medacta International S.A. | May 24, 2022 | SESE |
| K220405 | Amis K Long | Medacta International S.A. | Apr 12, 2022 | SESE |
| K213675 | MP Reconstruction System | Waldemar Link GmbH & Co. KG | Apr 11, 2022 | SESE |
| K212069 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | Apr 7, 2022 | SESE |
| K213839 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | Jan 6, 2022 | SESE |
| K213129 | Restoration Modular 115mm Conical Distal Stem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Dec 21, 2021 | SESE |
| K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Total Joint Othopedics, Inc. | Dec 3, 2021 | SESE |
| K210263 | Mpres Neck Preserving Stem | Medacta International S.A. | Sep 22, 2021 | SESE |
| K211657 | EMPHASYS Femoral Stems | Depuy Ireland UC | Aug 5, 2021 | SESE |
| K201657 | Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads | Corin, Ltd. | Jul 28, 2021 | SESE |
| K203175 | POLARSTEM Cemented Femoral Stem | Smith & Nephew, Inc. | Jul 22, 2021 | SESE |
| K211548 | POLARSTEM Calcar Reamer Guide | Smith & Nephew, Inc. | Jul 19, 2021 | SESE |
| K203532 | BI-MENTUM ALTRX® Dual Mobility Liner | Depuy Ireland UC | Apr 28, 2021 | SESE |
| K201047 | Fusion Taper System | Signature Orthopaedics Pty, Ltd. | Apr 16, 2021 | SESE |
| K202768 | KOSMO Femoral Stem | B-One Ortho, Corp. | Apr 1, 2021 | SESE |
| K203420 | EcoFit® Hip System | Implantcast GmbH | Feb 3, 2021 | SESE |
| K201471 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | Jan 11, 2021 | SESE |
| K202730 | Quadra-P | Medacta International S.A. | Dec 28, 2020 | SESE |
| K200196 | Taperloc® Complete Hip Stems | Biomet Orthopedics | Dec 8, 2020 | SESE |
| K203041 | SMS Cementless Stem | Medacta International S.A. | Dec 2, 2020 | SESE |
| K203167 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | Nov 19, 2020 | SESE |
| K201673 | SMS Cementless Stem | Medacta International S.A. | Sep 18, 2020 | SESE |
| K192883 | Spartan Hip Stem | Signature Orthopaedics Pty, Ltd. | Aug 5, 2020 | SESE |
| K193545 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | Aug 4, 2020 | SESE |
| K201951 | Cemented Origin Hip Stem | Signature Orthopaedics Pty, Ltd. | Jul 31, 2020 | SESE |
| K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | Biomet UK, Ltd. | Jul 29, 2020 | SESE |
| K192024 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | Jun 19, 2020 | SESE |
| K191816 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | Apr 29, 2020 | SESE |
| K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | Microport Orthopedics, Inc. | Apr 25, 2020 | SESE |
| K200112 | Zimmer Hip Joint Replacement | Zimmer GmbH | Apr 10, 2020 | SESE |
| K192660 | Zimmer M/L Taper Hip Prosthesis | Zimmer, Inc. | Feb 28, 2020 | SESE |
| K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads | Biomet UK, Ltd. | Feb 27, 2020 | SESE |
| K191831 | MobiliT Cup | Corin U.S.A. Limited | Jan 16, 2020 | SESE |
| K193433 | AMIStem-C | Medacta International S.A. | Jan 9, 2020 | SESE |
| K192827 | Quadra-P | Medacta International S.A. | Jan 6, 2020 | SESE |
| K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem | Zimmer GmbH | Dec 26, 2019 | SESE |
| K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | Waldemar Link GmbH & Co. KG | Dec 21, 2019 | SESE |
| K192189 | Avenir Complete Hip System, Size 0 Coxa Vara | Zimmer, Inc. | Dec 18, 2019 | SESE |
| K193030 | Avenir Muller Stem, Avenir Cemented Hip Stem | Zimmer GmbH | Dec 6, 2019 | SESE |
| K192946 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | Nov 26, 2019 | SESE |
| K192126 | AMIStem-P Short Neck | Medacta International S.A. | Nov 22, 2019 | SESE |
| K190344 | DePuy Corail AMT Hip Prosthesis | Depuy(Ireland) | Nov 1, 2019 | SESE |
| K190890 | Exactech Alteon Modular Dual Mobility (MDM) System | Exactech, Inc. | Oct 22, 2019 | SESE |
| K191632 | PROFEMUR TL2 Stems | Microport Orthopedics, Inc. | Oct 7, 2019 | SESE |
| K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System | Zimmer GmbH | Oct 1, 2019 | SESE |
| K192352 | MiniMAX | Medacta International S.A. | Sep 27, 2019 | SESE |
| K191399 | BIOLOX CONTOURA Ceramic Femoral Head | Total Joint Othopedics, Inc. | Aug 28, 2019 | SESE |
| K190704 | Signature Ceramic Femoral Head | Signature Orthopaedics Pty, Ltd. | Aug 28, 2019 | SESE |
| K183684 | Libertas Taper Uncemented Femoral Stem | Maxx Orthopedics, Inc. | Aug 23, 2019 | SESE |
| K183312 | Conformity Stem | United Orthopedic Corporation | Aug 8, 2019 | SESE |
| K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | Zimmer GmbH | Aug 6, 2019 | SESE |
| K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | Aug 6, 2019 | SESE |
| K191374 | Revival Modular Hip Stem | Corin U.S.A. Limited | Jul 22, 2019 | SESE |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Corin USA | Jul 22, 2019 | SESE |
| K183532 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | Jul 18, 2019 | SESE |
| K191145 | MasterLoc Extension | Medacta International S.A. | May 30, 2019 | SESE |
| K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | May 24, 2019 | SESE |
| K181491 | Delta Dual Mobility System | Lima Corporate S.P.A. | May 9, 2019 | SESE |
| K181171 | Zimmer Biomet Ceramic Heads | Zimmer, Inc. | Apr 2, 2019 | SESE |
| K183365 | Libertas Acetabular Hooded Liner | Maxx Orthopedics, Inc. | Feb 22, 2019 | SESE |
| K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups | B-One Ortho, Corp. | Feb 14, 2019 | SESE |
| K183141 | LINK MP Monoblock Hip Prosthesis | Waldemar Link GmbH & Co. KG | Feb 8, 2019 | SESE |
| K183136 | Zimmer Segmental System Proximal Femoral Component | Zimmer, Inc. | Jan 30, 2019 | SESE |
| K181761 | Zimmer Biomet Select Ceramic Heads | Zimmer, Inc. | Dec 26, 2018 | SESE |
| K181744 | BI-MENTUM dual mobility system | Serf | Dec 11, 2018 | SESE |
| K182048 | Avenir Complete Hip System | Zimmer, Inc. | Dec 7, 2018 | SESE |
| K181693 | SMS Femoral Stem | Medacta International S.A. | Nov 28, 2018 | SESE |
| K182462 | Exactech Alteon Highly Polished Femoral Stem | Exactech, Inc. | Nov 8, 2018 | SESE |
| K181254 | Quadra P | Medacta International S.A. | Oct 22, 2018 | SESE |
| K173960 | DePuy Corail AMT Hip Prosthesis | Depuy France S.A.S. | Sep 21, 2018 | SESE |
| K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | Sep 20, 2018 | SESE |
| K181598 | Prime E-CLASS XLPE Liner | Microport Orthopedics, Inc. | Sep 14, 2018 | SESE |
| K181061 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | Sep 7, 2018 | SESE |
| K181532 | Exactech Alteon Monobloc Revision Stem | Exactech, Inc. | Sep 4, 2018 | SESE |
| K173380 | b-ONE® Total Hip System | B-One Ortho, Corp. | Aug 30, 2018 | SESE |
| K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | Jul 20, 2018 | SESE |
| K173776 | BIOLOX delta Option and Extra-long Heads | Microport Orthopedics, Inc. | Jul 6, 2018 | SESE |
| K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | May 9, 2018 | SESE |
| K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | Apr 26, 2018 | SESE |
| K172235 | CoreHip® System | Aesculap Implants Systems, LLC | Mar 28, 2018 | SESE |
| K173794 | AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared | Medacta International S.A. | Mar 14, 2018 | SESE |
| K172467 | OMNI ARC Anteverted Neck Hip Stem | Omnilife Science | Dec 21, 2017 | SESE |
| K173267 | MasterLoc Stem: Lateralized Plus | Medacta International S.A. | Dec 7, 2017 | SESE |
| K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | Nov 29, 2017 | SESE |
| K170473 | C2 femoral stem | Lima Corporate S.P.A. | Nov 8, 2017 | SESE |
| K170359 | Trinity Dual Mobility System | Corin U.S.A. Limited | Oct 31, 2017 | SESE |
| K170089 | U-Motion II Acetabular System Additional sizes | United Orthopedic Corporation | Oct 6, 2017 | SESE |
| K163577 | Ecofit® Hip System | Implantcast GmbH | Sep 25, 2017 | SESE |
| K171181 | PROCOTYL® PRIME E-CLASS XLPE Liner | Microport Orthopedics, Inc. | Aug 28, 2017 | SESE |
| K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | Aug 25, 2017 | SESE |
| K171156 | OMNI Anseris Hip Stem | Omnilife Science | Aug 17, 2017 | SESE |
| K170845 | MiniMAX | Medacta International S.A. | Aug 8, 2017 | SESE |
| K162942 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | Jun 20, 2017 | SESE |
| K163585 | Responsive Orthopedics Total Hip Arthroplasty System | Responsive Orthopedics, LLC | Jun 2, 2017 | SESE |
| K161635 | AMIStem-H Proximal Coating | Medacta International S.A. | Mar 31, 2017 | SESE |
| 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 | Mar 16, 2017 | SESE |
| K161226 | Revision Femoral Stem | Lima Corporate S.P.A. | Feb 10, 2017 | SESE |
| K160895 | Initia Total Hip System & BIOCERAM AZUL(R) HEAD | Kyocera Medical Corporation | Nov 1, 2016 | SESE |
| K161830 | Zimmer M/L Taper Hip Prosthesis | Zimmer, Inc. | Oct 26, 2016 | SESE |
| K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | Jul 8, 2016 | SESE |
| K152893 | Corin Optimized Positioning System (OPS) | Corin USA | Jun 3, 2016 | SESE |
| K160289 | MasterLoc Stem | Medacta International | May 20, 2016 | SESE |
| K152903 | REVIVAL(TM) Modular Revision Hip Stem | Corin USA | Apr 29, 2016 | SESE |
| K152530 | UCP Stem | United Orthopedic Corporation | Mar 14, 2016 | SESE |
| K152919 | OMNI Skirted Heads | Omni Life Science, Inc. | Mar 10, 2016 | SESE |
| K151307 | ICONACY(TM) I-Hip (TM) | Iconacy Orthopedic Implants, LLC | Feb 26, 2016 | SESE |
| K153381 | Corin Metafix Hip Stem | Corin U.S.A. Limited | Jan 21, 2016 | SESE |
| K151739 | Revision Femoral Stem | Lima Corporate S.P.A. | Nov 23, 2015 | SESE |
| K151531 | MasterLoc Stem | Medacta International | Oct 30, 2015 | SESE |
| K150576 | TGM Biolox delta Ceramic Heads | Tgm Medical, Inc. | Sep 9, 2015 | SESE |
| K151902 | REDAPT¿ Revision Femoral System | Smith & Nephew, Inc. | Sep 3, 2015 | SESE |
| K150066 | Exactech Alteon Monobloc Revision Stem | Exactech, Inc. | Jul 20, 2015 | SESE |
| K150133 | PROFEMUR Preserve Size 1-3 Hip Stems | Microport Orthopedics, Inc. | Apr 20, 2015 | SESE |
| K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA | Smith & Nephew, Inc. | Apr 20, 2015 | SESE |
| K150302 | PROFEMUR Preserve Classic Stem | Microport Orthopedics, Inc. | Apr 10, 2015 | SESE |
| K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA | Smith & Nephew, Inc. | Mar 24, 2015 | SESE |
| K150062 | Excia Total Hip System | Aesculap Implant Systems, LLC | Feb 9, 2015 | SESE |
| K143509 | MasterSL femoral stem | Lima Corporate S.P.A. | Jan 27, 2015 | SESE |
| K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular Cup | Serf | Jan 15, 2015 | SESE |
| K143407 | Klassic HD Hip System | Total Joint Othopedics, Inc. | Dec 23, 2014 | SESE |
| K141377 | BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD | Merete Medical GmbH | Nov 21, 2014 | SESE |
| K142187 | LINK MP RECONSTRUCTION PROSTHESIS | Waldemar Link GmbH & Co. KG | Nov 6, 2014 | SESE |
| K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS | Microport Orthopedics, Inc. | Sep 12, 2014 | SESE |
| K141821 | ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET | Exactech, Inc. | Aug 28, 2014 | SESE |
| K141653 | BIOLOX DELTA CERAMIC OPTION HEADS | Biomet, Inc. | Aug 18, 2014 | SESE |
| K141327 | MINIMA S SYSTEM | Lima Corporate S.P.A. | Aug 6, 2014 | SESE |
| K140915 | EXCIA TOTAL HIP SYSTEM | Aesculap Implant Systems, LLC | Jul 21, 2014 | SESE |
| K140674 | EXACTECH TAPERED WEDGE FEMORAL STEM | Exactech, Inc. | Jun 30, 2014 | SESE |
| K140975 | MASTERSL FEMORAL STEM | Lima Corporate S.P.A. | Jun 10, 2014 | SESE |
| K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS | Microport Orthopedics, Inc. | May 30, 2014 | SESE |
| K140043 | DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD | Microport Orthopedics, Inc. | Apr 3, 2014 | SESE |
| K133381 | OMNI ARC MONOBLOCK HIP STEM | Omnilife Science | Mar 13, 2014 | SESE |
| K131986 | CORIN MINIHIP STEM | Corin USA | Dec 16, 2013 | SESE |
| K131952 | CORIN METAFIX HIP STEM | Corin USA | Dec 16, 2013 | SESE |
| K131518 | MECTACER BIOLOX OPTION HEADS | Medacta International | Nov 4, 2013 | SESE |
| K132435 | SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS | Smith & Nephew, Inc. | Oct 22, 2013 | SESE |
| K131684 | BIOLOX(R) DELTA CERAMIC HEADS | Biomet, Inc. | Oct 10, 2013 | SESE |
| K130728 | POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA | Smith & Nephew, Inc. | Oct 10, 2013 | SESE |
| K131458 | MPACT DM LINER CONVERTER | Medacta International | Oct 1, 2013 | SESE |
| K131647 | TRINITY ACETABULAR SYSTEM | Corin USA | Sep 27, 2013 | SESE |
| K132455 | U-MOTION II PS+ CUP | United Orthopedic Corp. | Sep 3, 2013 | SESE |
| K131884 | AVENIR CEMENTED HIP STEM | Zimmer GmbH | Aug 22, 2013 | SESE |
| K130376 | DYNASTY ACETABULAR SYSTEM WITH CERAMIC | Wrightmedicaltechnologyinc | Jul 3, 2013 | SESE |
| K130343 | CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS | Corin USA | May 28, 2013 | SESE |
| K130984 | PROFEMUR RENAISSANCE CLASSIC HIP STEM | Wrightmedicaltechnologyinc | May 24, 2013 | SESE |
| K130634 | CORIN METAFIX HIP STEM | Corin USA | May 24, 2013 | SESE |
| K123619 | INTRABLOCK BIOBALL HIP SYSTEM (IBS) | Merete Medical GmbH | May 24, 2013 | SESE |
| K130899 | BIOLOX DELTA CERAMIC FEMORAL HEADS | Zimmer GmbH | May 1, 2013 | SESE |
| K130167 | PROFEMUR XM DISTAL CENTRALIZER | Wrightmedicaltechnologyinc | Apr 19, 2013 | SESE |
| K123782 | PARAGON HIP SYSTEM | Global Manufacturing Technology | Mar 14, 2013 | SESE |
| K130128 | TRINITY ACETABULAR SYSTEM | Corin Medical | Mar 8, 2013 | SESE |
| K123392 | AVENIR MULLER STEM | Zimmer GmbH | Mar 4, 2013 | SESE |
| K123924 | DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS | Depuy Orthopaedics | Mar 1, 2013 | SESE |
| K122185 | U-MOTION II ACETABULAR SYSTEM | United Orthopedic Corp. | Feb 22, 2013 | SESE |
| K123705 | TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS | Corin USA | Feb 12, 2013 | SESE |
| K123688 | PROFEMUR TL CLASSIC HIP STEM | Wrightmedicaltechnologyinc | Feb 8, 2013 | SESE |
Top Applicants
- Medacta International S.A. — 27 clearances
- Smith & Nephew, Inc. — 24 clearances
- Howmedica Osteonics Corp. — 23 clearances
- Zimmer, Inc. — 21 clearances
- Exactech, Inc. — 21 clearances
