LPH · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Orthopedic · 21 CFR 888.3358 · Class 2
Overview
| Product Code | LPH |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Regulation | 21 CFR 888.3358 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.
Classification Rationale
Class II.
Cleared Devices (559)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | Feb 4, 2026 | SESE |
| K251043 | Mpact 3D Metal Implants Extension DMLS Technology | Medacta International S.A. | Jan 28, 2026 | SESE |
| K252067 | Velora Acetabular System | Restor3D, Inc. | Dec 5, 2025 | SESE |
| K252846 | TaperSet Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | Nov 20, 2025 | SESE |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | Nov 12, 2025 | SESE |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | Aug 29, 2025 | SESE |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | Jul 25, 2025 | SESE |
| K243456 | ONVOY Acetabular System | Globus Medical, Inc. | Jun 6, 2025 | SESE |
| K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | Jun 5, 2025 | SESE |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | Apr 23, 2025 | SESE |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | Apr 10, 2025 | SESE |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 6, 2025 | SESE |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | Jan 22, 2025 | SESE |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | Jan 13, 2025 | SESE |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | Nov 8, 2024 | SESE |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | Oct 11, 2024 | SESE |
| K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | Oct 7, 2024 | SESE |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC | Oct 7, 2024 | SESE |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | Apr 18, 2024 | SESE |
| K231522 | EMPHASYS Dual Mobility System | Depuy Ireland UC | Feb 15, 2024 | SESE |
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Dec 21, 2023 | SESE |
| K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | Oct 27, 2023 | SESE |
| K232556 | DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System | Depuy Ireland UC | Sep 20, 2023 | SESE |
| K230011 | Mpact Extension | Medacta International S.A. | Sep 20, 2023 | SESE |
| K222436 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | May 9, 2023 | SESE |
| K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | Apr 14, 2023 | SESE |
| K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | Feb 27, 2023 | SESE |
| K223779 | EMPOWR blade stem | Encore Medical, LLC | Feb 13, 2023 | SESE |
| K223348 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical, Inc. | Jan 30, 2023 | SESE |
| K211047 | CoCr Head | Zimmer GmbH | Jan 10, 2023 | SESE |
| K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | Nov 4, 2022 | SESE |
| K213842 | ONVOY Acetabular System | Globus Medical, Inc. | Oct 3, 2022 | SESE |
| K220336 | Mg-PSZ Ceramic Femoral Head | Theken Companies | Sep 30, 2022 | SESE |
| K221636 | EMPHASYS Acetabular System | Depuy Ireland UC | Sep 6, 2022 | SESE |
| K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | Aug 18, 2022 | SESE |
| K212815 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical | Jul 6, 2022 | SESE |
| K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | Jul 1, 2022 | SESE |
| K201348 | DePuy 3D Additive TriFlange Acetabular Cup | Depuy International, Ltd. | Jun 16, 2022 | SESE |
| K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | May 24, 2022 | SESE |
| K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | May 18, 2022 | SESE |
| K212761 | Biocore9 Acetabular Cup System | Biocore9, LLC | May 17, 2022 | SESE |
| K220376 | Acetabular Dome Hole Plug | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Mar 9, 2022 | SESE |
| K212187 | Restoration® Modular Hip System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Mar 1, 2022 | SESE |
| K211330 | R3 Large Head Liners | Smith & Nephew, Inc. | Jan 19, 2022 | SESE |
| K202568 | Mpact® 3D Metal Implants - DMLS Technology | Medacta International S.A. | Dec 20, 2021 | SESE |
| K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | Microport Orthopedics, Inc. | Oct 1, 2021 | SESE |
| K211866 | Bencox THR System | Corentec Co., Ltd. | Jul 14, 2021 | SESE |
| K201733 | Provident II Hip Stems | Globus Medical, Inc. | Jul 14, 2021 | SESE |
| K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters | Waldemar Link GmbH & Co. KG | May 28, 2021 | SESE |
| K200391 | MPACT Extension | Medacta International S.A. | Apr 28, 2021 | SESE |
| K210893 | Restoration Anatomic Shell | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Apr 22, 2021 | SESE |
| K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing | Encore Medical L.P. | Feb 10, 2021 | SESE |
| K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | Oct 21, 2020 | SESE |
| K202484 | Cordera Hip System | Conformis, Inc. | Sep 24, 2020 | SESE |
| K200854 | DePuy PINNACLE Dual Mobility Liner | Depuy Ireland UC | Sep 11, 2020 | SESE |
| K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head | Signature Orthopaedics Pty, Ltd. | Aug 14, 2020 | SESE |
| K200656 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | Jul 8, 2020 | SESE |
| K193233 | Restoration® Modular Hip System | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | May 27, 2020 | SESE |
| K191826 | KeYi Total Hip System | Beijing Keyi Medical Device Technology Co., Ltd. | May 14, 2020 | SESE |
| K192450 | Precision Casting Solutions Total Hip System | Precision Casting Solution, LLC | Dec 17, 2019 | SESE |
| K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings | Zimmer, Inc. | Dec 6, 2019 | SESE |
| K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene | Zimmer, Inc. | Dec 5, 2019 | SESE |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | Nov 26, 2019 | SESE |
| K192198 | Conformis Hip System | Conformis, Inc. | Nov 6, 2019 | SESE |
| K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head | Zimmer, Inc. | Nov 5, 2019 | SESE |
| K191622 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | Nov 1, 2019 | SESE |
| K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | Oct 31, 2019 | SESE |
| K190847 | REDAPT Blade Augments | Smith & Nephew, Inc. | Oct 25, 2019 | SESE |
| K191358 | Trident II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Oct 24, 2019 | SESE |
| K192071 | iNSitu Total Hip System | Theken Companies, LLC | Aug 30, 2019 | SESE |
| K190904 | Conformis BeneFIT Hip System | Conformis, Inc. | Aug 28, 2019 | SESE |
| K191936 | iNSitu Total Hip System | Thecken Companies, LLC | Aug 20, 2019 | SESE |
| K183129 | Medtronic Total Hip Arthroplasty System | Medtronic Advanced Energy | Jul 26, 2019 | SESE |
| K190123 | MicroPort CoCr Femoral Heads | Microport Orthopedics, Inc. | Jul 15, 2019 | SESE |
| K190057 | DJO Acetabular System | Encore Medical L.P. | Jun 7, 2019 | SESE |
| K182678 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling | Zimmer, Inc. | May 31, 2019 | SESE |
| K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | Apr 1, 2019 | SESE |
| K183582 | MPACT Extension | Medacta International S.A. | Mar 21, 2019 | SESE |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Mar 19, 2019 | SESE |
| K182502 | Alteon Acetabular Cup System | Exactech, Inc. | Mar 13, 2019 | SESE |
| K190276 | Provident II Hip Stem | Stelkast, Inc. | Mar 8, 2019 | SESE |
| K182099 | Delta TT Pro | Lima Corporate S.P.A. | Dec 26, 2018 | SESE |
| K182109 | REDAPT Modular Acetabular Shell | Smith & Nephew, Inc. | Nov 16, 2018 | SESE |
| K181366 | REDAPT Porous Acetabular Shell | Smith & Nephew, Inc. | Sep 24, 2018 | SESE |
| K172857 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | Jul 19, 2018 | SESE |
| K180798 | Prime Acetabular Cup System | Microport Orthopedics, Inc. | Jul 9, 2018 | SESE |
| K172551 | Trinity PLUS Acetabular Shell | Corin U.S.A. Limited | Jun 15, 2018 | SESE |
| K173951 | Legend Acetabular Liners | Ortho Development Corporation | May 30, 2018 | SESE |
| K171966 | Mpact® 3D Metal Implants and Augments 3D Metal | Medacta International S.A. | Mar 27, 2018 | SESE |
| K172456 | Bone Screws 6.5mm | Lima Corporate S.P.A. | Jan 4, 2018 | SESE |
| K171934 | Birmingham Hip (BH) Dual Mobility Insert | Smith & Nephew, Inc. | Nov 30, 2017 | SESE |
| K171073 | Smith & Nephew, Inc. REDAPT Augments | Smith & Nephew, Inc. | Nov 21, 2017 | SESE |
| K172251 | UTS Stem | United Orthopedic Corporation | Oct 24, 2017 | SESE |
| K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | Oct 17, 2017 | SESE |
| K172684 | Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem | Smith & Nephew, Inc. | Oct 3, 2017 | SESE |
| K171768 | Trident® II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Oct 2, 2017 | SESE |
| K172501 | iNSitu Total Hip System | Theken Companies, LLC | Sep 21, 2017 | SESE |
| K171962 | Klassic HD® Hip System | Total Joint Othopedics, Inc. | Jul 24, 2017 | SESE |
| K162957 | U2 Femoral Head | United Orthopedic Corporation | Jul 17, 2017 | SESE |
| K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | Jun 26, 2017 | SESE |
| K162719 | iTotal® Hip Replacement System | Conformis, Inc. | Jun 14, 2017 | SESE |
| K163193 | UTF Stem, reduced, #0, #00 | United Orthopedic Corporation | Jun 8, 2017 | SESE |
| K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | Dec 5, 2016 | SESE |
| K161073 | Klassic HD Hip System | Total Joint Othopedics, Inc. | Oct 19, 2016 | SESE |
| K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Oct 14, 2016 | SESE |
| K161184 | iNSitu Total Hip System | Theken Companies, LLC | Oct 14, 2016 | SESE |
| K151424 | The Progressive Orthopaedic Total Hip System | The Progressive Orthopaedic Company, LLC | Jul 27, 2016 | SESE |
| K161190 | G7 Dual Mobility System, Active Articulation System | Biomet, Inc. | May 26, 2016 | SESE |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | May 25, 2016 | SESE |
| K161080 | Escalade Legend Acetabular Shell | Ortho Development Corporation | May 17, 2016 | SESE |
| K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug | Corentec Co., Ltd. | Apr 29, 2016 | SESE |
| K160266 | ICONACY(TM) I-Hip(TM) | Iconacy Orthopedic Implants, LLC | Apr 8, 2016 | SESE |
| K150790 | REDAPT Porous Acetabular Shell and Cemented Liner | Smith & Nephew, Inc. | Nov 16, 2015 | SESE |
| K151603 | Arcos One-piece Femoral Revision System | Biomet, Inc. | Oct 6, 2015 | SESE |
| K151440 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | Sep 3, 2015 | SESE |
| K141960 | Exactech® Novation® Crown Cup® | Exactech, Inc. | Sep 3, 2015 | SESE |
| K151448 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems | Zimmer, Inc. | Aug 13, 2015 | SESE |
| K151316 | U2 Hip Stem, Ti Porous Coated, Matrix | United Orthopedic Corporation | Aug 13, 2015 | SESE |
| K151264 | Restoration Anatomic Shell | Stryker Orthopaedics | Aug 10, 2015 | SESE |
| K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | May 4, 2015 | SESE |
| K150522 | G7 Dual Mobility System | Biomet, Inc. | May 1, 2015 | SESE |
| K150503 | Echo Bi-Metric Microplasty Line Extension | Biomet, Inc. | Mar 25, 2015 | SESE |
| K143453 | Mpact Double Mobility System | Medacta International | Mar 2, 2015 | SESE |
| K143314 | Progressive Orthopaedic Total Hip System | The Progressive Orthopaedic Company, LLC | Feb 27, 2015 | SESE |
| K142119 | PROCOTYL L-O ACETABULAR SYSTEM | Microport Orthopedics, Inc. | Feb 27, 2015 | SESE |
| K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | Biomet, Inc. | Feb 10, 2015 | SESE |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach | Stryker Orthopaedics | Feb 9, 2015 | SESE |
| K142606 | Trident® Tritanium® PST® Acetabular Shells | Mako Surgical Corp. | Jan 26, 2015 | SESE |
| K142201 | OMNI Interface Acetabular System | Omnlife Science | Jan 26, 2015 | SESE |
| K140547 | EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM | Excera Orthopedics, Inc. | Jan 22, 2015 | SESE |
| K142746 | G7 Finned Acetabular Shell | Biomet Manufactuting Corp. | Dec 29, 2014 | SESE |
| K143009 | Echo Bi-Metric Microplasty Hip System | Biomet, Inc. | Dec 18, 2014 | SESE |
| K140669 | G7 OSSEOTI ACETUBLAR SHELLS | Biomet, Inc. | Dec 11, 2014 | SESE |
| K142462 | Restoration Anatomic Shell | Stryker Orthopaedics | Nov 14, 2014 | SESE |
| K141676 | RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM | Renovis Surgical Technologies, Inc. | Nov 4, 2014 | SESE |
| K141001 | ALPINE HIP STEM; ALPINE HA HIP STEM | Ortho Development | Jul 30, 2014 | SESE |
| K141797 | ALTEON 6.5MM BONE SCREWS | Exactech, Inc. | Jul 29, 2014 | SESE |
| K133370 | REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE | Signature Orthopaedics Pty Limited | Jul 22, 2014 | SESE |
| K141395 | DELTA TT ACETABULAR SYSTEM | Lima Corporate S.P.A. | Jun 30, 2014 | SESE |
| K132697 | ENCOMPASS 10/12 HIP STEM | Ortho Development Corp. | Jun 20, 2014 | SESE |
| K141043 | CS2 MULTI-HOLE ACETABULAR SHELL | Consensus Orthopedics, Inc. | May 19, 2014 | SESE |
| K132312 | RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM | Renovis Surgical Technologies, LLC | Apr 11, 2014 | SESE |
| K132572 | I-HIP TOTAL HIP SYSTEM | Iconacy Orthopedic Implants, LLC | Mar 28, 2014 | SESE |
| K133832 | KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS | Total Joint Orthopedics, Inc. | Mar 13, 2014 | SESE |
| K133386 | OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM | Ortho Development Corp. | Mar 11, 2014 | SESE |
| K132959 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | DePuy Orthopaedics, Inc. | Mar 10, 2014 | SESE |
| K132158 | NOVOHIP TOTAL HIP SYSTEM | Novosource, Inc. | Feb 21, 2014 | SESE |
| K131454 | KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD | Total Joint Orthopedics, Inc. | Feb 12, 2014 | SESE |
| K132879 | MPACT EXTENSION | Medacta International | Jan 22, 2014 | SESE |
| K133228 | ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM | Iconacy Orthopedic Implants, LLC | Jan 17, 2014 | SESE |
| K131022 | OVATION 10/12 HIP STEM | Ortho Development Corp. | Oct 16, 2013 | SESE |
| K132626 | PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) | Pipeline Biotechnology | Sep 19, 2013 | SESE |
| K132207 | UTF STEM-REDUCED, ADDITIONAL SIZES | United Orthopedic Corporation | Aug 30, 2013 | SESE |
| K131279 | ICONACY I-HIP SYSTEM | Iconacy Orthopedic Implants, LLC | Aug 9, 2013 | SESE |
| K130353 | PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) | Pipeline Orthopedics | Jul 1, 2013 | SESE |
| K130099 | TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 | Encore Medical L.P. | Jun 21, 2013 | SESE |
| K131237 | PIPELINE TOTAL HIP SYSTEM | Pipeline Orthopedics | Jun 13, 2013 | SESE |
| K130149 | U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE | United Orthopedic Corporation | Jun 6, 2013 | SESE |
| K123550 | UTF STEM, REDUCED | United Orthopedic Corporation | May 1, 2013 | SESE |
| K120599 | DEPUY M-SPEC 36MM FEMORAL HEADS | Depuy Orthopaedics | Apr 30, 2013 | SESE |
| K130063 | ARCOS TROCHANTER BUTTON | Biomet, Inc. | Apr 19, 2013 | SESE |
| K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR | Signature Orthopaedics Pty, Ltd. | Dec 28, 2012 | SESE |
| K112898 | DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS | Lima Corporate S.P.A. | Dec 21, 2012 | SESE |
| K122512 | CS2 HIP SYSTEM | Consensus Orthopedics, Inc. | Nov 5, 2012 | SESE |
| K122636 | REVELATION POROUS COATED HIP STEM, SIZE 8 | Encore Medical L.P. | Nov 2, 2012 | SESE |
| K123012 | SMITH & NEPHEW SMF HIP STEM | Smith & Nephew, Inc. | Oct 24, 2012 | SESE |
| K121636 | ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT | Tgm Medical, Inc. | Oct 24, 2012 | SESE |
| K123019 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS | Zimmer, Inc. | Oct 22, 2012 | SESE |
| K122798 | INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL | Exactech, Inc. | Oct 11, 2012 | SESE |
| K122504 | FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH | United Orthopedic Corporation | Oct 10, 2012 | SESE |
| K122099 | BENCOX II STEM, BENCOX METAL HEAD | Corentec Co., Ltd. | Oct 5, 2012 | SESE |
| K121684 | NOVATION LPI PRIME FEMORAL STEM | Exactech, Inc. | Oct 1, 2012 | SESE |
| K113296 | ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER | Zimmer, Inc. | Sep 14, 2012 | SESE |
| K121935 | TAPERSET HIP SMALL STEMS | Consensus Orthopedics, Inc. | Sep 10, 2012 | SESE |
| K120924 | BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG | Corentec Co., Ltd. | Sep 10, 2012 | SESE |
| K121034 | IOI TOTAL HIP | Iconacy Orthopedic Implants, LLC | Sep 4, 2012 | SESE |
| K122244 | POLARCUP DUAL MOBILITY SYSTEM | Smith & Nephew, Inc. | Aug 23, 2012 | SESE |
| K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | Biomet Manufacturing Corp | Aug 17, 2012 | SESE |
| K121308 | HIP SYSTEMS | Howmedica Osteonics Corp. | Jul 30, 2012 | SESE |
| K121777 | U2 ACETABULAR CUP, PLASMA SPRAY | United Orthopedic Corp. | Jul 18, 2012 | SESE |
| K121024 | LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; | Encore Medical L.P. | Jun 19, 2012 | SESE |
| K121263 | TAPER SET HIP SYSTEM RDP STEM | Consensus Orthopedics, Inc. | May 22, 2012 | SESE |
| K112158 | MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS | Lima Corporate S.P.A. | May 10, 2012 | SESE |
| K120241 | LINEAR HIP STEM, SIZE 5 | Encore Medical L.P. | Feb 24, 2012 | SESE |
| K113242 | APEX ARC HIP STEM | Omni Life Science, Inc. | Jan 5, 2012 | SESE |
| K113609 | NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 | Exactech, Inc. | Jan 4, 2012 | SESE |
| K112779 | APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) | Omnlife Science | Dec 2, 2011 | SESE |
| K110135 | POLARCUP DUAL MOBILITY SYSTEM | Smith & Nephew, Inc. | Oct 14, 2011 | SESE |
| K111472 | HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON | Tgm Medical | Sep 6, 2011 | SESE |
| K110245 | UNITED UTF STEM | United Orthopedic Corporation | Aug 4, 2011 | SESE |
| K103431 | COREN TOTAL HIP SYSTEM | Corentec Co., Ltd. | Jul 21, 2011 | SESE |
| K111546 | U2 HIP SYSTEM | United Orthopedic Corp. | Jul 1, 2011 | SESE |
| K110947 | APEX K1 HIP STEM | Omni Life Science, Inc. | Jun 16, 2011 | SESE |
| K103662 | CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI | Zimmer, Inc. | Apr 15, 2011 | SESE |
| K101072 | TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE | Howmedica Osteonics Corp. | Apr 11, 2011 | SESE |
| K110542 | CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD | Consensus Orthopedics, Inc. | Apr 1, 2011 | SESE |
| K110555 | ARCOMXL ACTIVE ARTICULATION | Biomet Manufacturing Corp | Mar 24, 2011 | SESE |
| K103721 | MPACT ACETABULAR SYSTEM | Medacta International | Mar 21, 2011 | SESE |
| K103384 | ESCALADE ACETABULAR CUP SYSTEM | Ortho Development | Mar 16, 2011 | SESE |
| K102019 | RESTORATION ACETABULAR WEDGE AUGMENTS | Howmedica Osteonics | Mar 3, 2011 | SESE |
Top Applicants
- Zimmer, Inc. — 45 clearances
- Biomet, Inc. — 43 clearances
- Smith & Nephew, Inc. — 32 clearances
- DePuy Orthopaedics, Inc. — 32 clearances
- Depuy, Inc. — 24 clearances
