JDI · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Orthopedic · 21 CFR 888.3350 · Class 2
Overview
| Product Code | JDI |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Regulation | 21 CFR 888.3350 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (562)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | Jul 31, 2025 | SESE |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | Oct 21, 2024 | SESE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Aug 2, 2024 | SESE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Apr 12, 2024 | SESE |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Dec 8, 2023 | SESE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Jan 26, 2023 | SESE |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | Jul 22, 2022 | SESE |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 1, 2022 | SESE |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | Jan 5, 2022 | SESE |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | Dec 10, 2021 | SESE |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | Jun 9, 2021 | SESE |
| K203588 | ELEOS Limb Salvage System | Onkos Surgical | Feb 5, 2021 | SESE |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | Dec 11, 2020 | SESE |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | Microport Orthopedics, Inc. | Dec 10, 2020 | SESE |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | Aug 13, 2020 | SESE |
| K191449 | ZCA All-Poly Acetabular Cups | Zimmer, Inc. | Jul 16, 2020 | SESE |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | Jul 9, 2020 | SESE |
| K191735 | CPT Hip System | Zimmer, Inc. | Mar 20, 2020 | SESE |
| K191056 | Conformity stem, cemented | United Orthopedic Corporation | Jan 3, 2020 | SESE |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics | Aug 28, 2019 | SESE |
| K181340 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | Feb 11, 2019 | SESE |
| K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | Sep 28, 2018 | SESE |
| K162125 | MALUC Total Hip Arthroplasty System | Surgtech, Inc. | May 10, 2017 | SESE |
| K160923 | REDAPT Anteverted Cemented Liner | Smith & Nephew, Inc. | Nov 17, 2016 | SESE |
| K153057 | FitRite Total Hip Arthroplasty System | Excera Orthopedics, Inc. | Jun 23, 2016 | SESE |
| K153725 | Corin TaperFit Hip Stem | Corin U.S.A. Limited | Mar 25, 2016 | SESE |
| K153216 | Alpine Cemented Hip System | Ortho Development Corporation | Feb 18, 2016 | SESE |
| K152621 | OSS/Arcos IM Total Femur Rod | Biomet, Inc. | Oct 14, 2015 | SESE |
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | Jun 25, 2015 | SESE |
| K142761 | Corin TaperFit Hip Stem | Corin USA | Apr 3, 2015 | SESE |
| K141331 | BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) | Biomet, Inc. | Oct 27, 2014 | SESE |
| K142295 | Sirius Femoral Stem, Size 30A | Biomet, Inc. | Sep 15, 2014 | SESE |
| K141370 | RENOVIS CEMENTED HIP SYSTEM | Renovis Surgical Technologies, Inc. | Sep 2, 2014 | SESE |
| K130610 | SIRIUS FEMORAL STEM | Biomet, Inc. | Aug 30, 2013 | SESE |
| K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION | Smith & Nephew, Inc. | Jun 28, 2013 | SESE |
| K123501 | OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS | Biomet, Inc. | Feb 27, 2013 | SESE |
| K121056 | METS MODULAR PROXIMAL FEMUR | Stanmore Implants Worldwide , Ltd. | Sep 20, 2012 | SESE |
| K121055 | METS MODULAR TOTAL FEMUR | Stanmore Implants Worldwide , Ltd. | Sep 19, 2012 | SESE |
| K111863 | SIGNATURE PLANNER,SIGNATURE GUIDES | Materialise NV | Jun 15, 2012 | SESE |
| K120578 | ACCOLADE II HIP STEM | Howmedica Osteonics | Mar 29, 2012 | SESE |
| K111848 | EXETER X3 RIMFIT ACETABULAR CUP | Stryker Corp. | Oct 5, 2011 | SESE |
| K110290 | EXETER HIP STEM | Howmedica Osteonics Corp. | Sep 27, 2011 | SESE |
| K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | Dec 17, 2009 | SESE |
| K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | Jun 12, 2009 | SESE |
| K090208 | BIOPRO FEMORAL HEADS | Biopro, Inc. | May 22, 2009 | SESE |
| K082792 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS | Medacta International S.A. | Dec 29, 2008 | SESE |
| K082239 | DEPUY C-STEM AMT | DePuy Orthopaedics, Inc. | Aug 29, 2008 | SESE |
| K080539 | ACCIN UNIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | Jun 2, 2008 | SESE |
| K080885 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION | Medacta International S.A. | Apr 28, 2008 | SESE |
| K072857 | TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT | Medacta International S.A. | Feb 4, 2008 | SESE |
| K070399 | 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES | Biomet Manufacturing, Inc. | May 4, 2007 | SESE |
| K070364 | 100KGY E-POLY MAXROM ACETABULAR LINERS | Biomet, Inc. | May 3, 2007 | SESE |
| K063278 | PORTLAND COBALT CHROME FEMORAL HEAD | Portland Orthopaedics Limited | Jan 12, 2007 | SESE |
| K061344 | EXCIA TOTAL HIP SYSTEM LATERAL OFFSET | Aesculap, Inc. | Aug 2, 2006 | SESE |
| K052639 | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER | Biomet Manufacturing, Inc. | May 3, 2006 | SESE |
| K052748 | SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS | Howmedica Osteonics Corp. | Dec 2, 2005 | SESE |
| K052792 | ANTHOLOGY HIP STEM | Smith & Nephew, Inc. | Oct 7, 2005 | SESE |
| K051569 | RINGLOC BI-POLAR ACETABULAR COMPONENT | Biomet, Inc. | Sep 29, 2005 | SESE |
| K050637 | ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS | Ortho Development Corp. | Sep 23, 2005 | SESE |
| K051407 | LEGEND ALL-POLY CUP | Ortho Development Corp. | Sep 8, 2005 | SESE |
| K051516 | TRABECULAR METAL REVISION SHELL LINERS | Zimmer, Inc. | Jul 27, 2005 | SESE |
| K050441 | TAPER 2 POROUS FEMORAL STEM | Biomet, Inc. | Jun 29, 2005 | SESE |
| K051363 | RESTORATION MODULAR SYSTEM | Howmedica Osteonics Corp. | Jun 23, 2005 | SESE |
| K051335 | ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS | Exactech, Inc. | Jun 21, 2005 | SESE |
| K050105 | NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS | Zimmer, Inc. | May 17, 2005 | SESE |
| K050138 | MODIFICATION TO: RESTORATION MODULAR SYSTEM | Howmedica Osteonics Corp. | Mar 21, 2005 | SESE |
| K042959 | DEPUY C-STEM AMT HIP PROSTHESIS | DePuy Orthopaedics, Inc. | Dec 22, 2004 | SESE |
| K033871 | IM TOTAL FEMUR | Biomet, Inc. | Apr 16, 2004 | SESE |
| K032730 | FIXION HIP SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | Mar 26, 2004 | SESE |
| K034028 | ATH FEMORAL STEM | Wrightmedicaltechnologyinc | Mar 11, 2004 | SESE |
| K031474 | SC TOTAL HIP SYSTEM | Orthopedic Alliance, LLC | Oct 15, 2003 | SESE |
| K030867 | ESKA MODULAR HIP SYSTEM CEMENTED | Eska Implants GmbH | Sep 22, 2003 | SESE |
| K031730 | 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS | Howmedica Osteonics Corp. | Aug 29, 2003 | SESE |
| K032396 | RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS | Biomet, Inc. | Aug 21, 2003 | SESE |
| K031744 | OMNIFIT HFX HIP STEM SERIES | Howmedica Osteonics Corp. | Aug 8, 2003 | SESE |
| K030766 | OXINIUM FEMORAL HEADS | Smith & Nephew, Inc. | Jul 25, 2003 | SESE |
| K031734 | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS | Biomet, Inc. | Jul 1, 2003 | SESE |
| K031165 | PLUS ORTHOPEDICS CEMENTED HIP STEM | Plus Orthopedics | Jun 6, 2003 | SESE |
| K030153 | ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 | Zimmer, Inc. | Apr 1, 2003 | SESE |
| K030265 | CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 | Zimmer, Inc. | Mar 4, 2003 | SESE |
| K024340 | SMITH & NEPHEW FEMORAL HEADS | Smith & Nephew, Inc. | Feb 26, 2003 | SESE |
| K022799 | TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE | Howmedica Osteonics Corp. | Nov 21, 2002 | SESE |
| K023646 | EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM | Exactech, Inc. | Nov 13, 2002 | SESE |
| K023453 | DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS | DePuy Orthopaedics, Inc. | Nov 13, 2002 | SESE |
| K023085 | RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM | Biomet Orthopedics, Inc. | Oct 17, 2002 | SESE |
| K022958 | TOTAL HIP FEMORAL HEADS AND LINERS | Smith & Nephew, Inc. | Oct 2, 2002 | SESE |
| K022094 | PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING | Biomet, Inc. | Jul 25, 2002 | SESE |
| K022077 | 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) | Howmedica Osteonics Corp. | Jul 25, 2002 | SESE |
| K021822 | R120 MODULAR TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | Jul 23, 2002 | SESE |
| K021380 | OSS LES PROXIMAL FEMORAL COMPONENT | Biomet, Inc. | May 28, 2002 | SESE |
| K021310 | 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) | Howmedica Osteonics Corp. | May 21, 2002 | SESE |
| K021178 | SL-PLUS LATERALIZED STEM | Plus Orthopedics | May 14, 2002 | SESE |
| K020989 | SUPER EON PLUS FEMORAL STEMS | Howmedica Osteonics Corp. | Apr 26, 2002 | SESE |
| K020970 | MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) | Biomet, Inc. | Apr 4, 2002 | SESE |
| K020291 | EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER | Exactech, Inc. | Feb 27, 2002 | SESE |
| K020076 | PATRIOT PROTRUSIO CAGE | Biomet Orthopedics, Inc. | Jan 30, 2002 | SESE |
| K011887 | AVALON CUP SYSTEM | Orthopedic Source, Inc. | Dec 27, 2001 | SESE |
| K013352 | SUMMIT CEMENTED HIP PROSTHESIS | DePuy Orthopaedics, Inc. | Dec 17, 2001 | SESE |
| K013350 | MODIFICATION TO DEPUY C-STEM SYSTEM | DePuy Orthopaedics, Inc. | Nov 7, 2001 | SESE |
| K012961 | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | Oct 18, 2001 | SESE |
| K011774 | R120 MODULAR TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | Sep 5, 2001 | SESE |
| K012493 | ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 | Exactech, Inc. | Aug 29, 2001 | SESE |
| K011715 | MACROPORE IB RESORBABLE PLUG | Macropore Biosurgery, Inc. | Aug 27, 2001 | SESU |
| K012019 | COLOR BUFFED (CB) DDH FEMORAL STEM | Biomet, Inc. | Jul 20, 2001 | SESE |
| K012026 | TRIDENT ALL POLY CUP | Howmedica Osteonics Corp. | Jul 18, 2001 | SESE |
| K011455 | BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER | Biomet, Inc. | Jul 18, 2001 | SESE |
| K011623 | EXETER HIP SYSTEM WITH V40 TAPER | Howmedica Osteonics Corp. | Jun 15, 2001 | SESE |
| K011367 | EXCEL FRACTURE CEMENTED HIP STEM | DePuy Orthopaedics, Inc. | Jun 15, 2001 | SESE |
| K011218 | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 | Exactech, Inc. | May 16, 2001 | SESE |
| K010529 | TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA | Medtronic Sofamor Danek USA, Inc. | Apr 27, 2001 | SESU |
| K010757 | LFIT V40 FEMORAL HEAD COMPONENTS | Howmedica Osteonics Corp. | Apr 11, 2001 | SESE |
| K010310 | MODIFICATION TO TRIDENT ALL POLY CUP | Howmedica Osteonics Corp. | Mar 20, 2001 | SESE |
| K003976 | BAUMER MULLER HIP PROSTHESIS | Baumer, S.A | Mar 19, 2001 | SESE |
| K003975 | BAUMER CEMENTED HIP PROSTHESIS | Baumer, S.A | Mar 19, 2001 | SESE |
| K003666 | TAPER-FIT TOTAL HIP SYSTEM | Corin USA | Feb 8, 2001 | SESE |
| K001956 | TRIDENT ALL POLY CUP | Howmedica Osteonics Corp. | Dec 11, 2000 | SESE |
| K003421 | DEPUY C-STEM SYSTEM | DePuy Orthopaedics, Inc. | Dec 1, 2000 | SESE |
| K002757 | ONCOLOGY SALVAGE SYSTEM | Biomet, Inc. | Nov 24, 2000 | SESE |
| K002324 | MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA | Sulzermedica | Aug 24, 2000 | SESE |
| K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ | Implex Corp. | Aug 24, 2000 | SESE |
| K001571 | BAUMER FEMORAL HEAD | Baumer, S.A | Aug 4, 2000 | SESE |
| K002106 | NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER | Biomet, Inc. | Jul 27, 2000 | SESE |
| K001932 | TORNIER CEMENT RESTRICTOR | Tornier | Jul 20, 2000 | SESE |
| K001376 | TI-MAX PROTRUSIO CAGE | Biomet, Inc. | Jul 20, 2000 | SESE |
| K001078 | SULZER ORTHOPEDICS MS-30 FEMORAL STEM | Sulzer Orthopedics, Inc. | Jun 23, 2000 | SESE |
| K001733 | ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES | Zimmer, Inc. | Jun 20, 2000 | SESE |
| K000817 | OMEGA II MODULAR TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | Jun 8, 2000 | SESE |
| K001335 | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED | Exactech, Inc. | May 18, 2000 | SESE |
| K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ | Implex Corp. | Mar 1, 2000 | SESE |
| K000254 | PAR 5 ACETABULAR COMPONENT | Biomet, Inc. | Feb 7, 2000 | SESE |
| K994007 | MALLORY/HEAD SMOOTH FEMORAL COMPONENT | Biomet, Inc. | Feb 4, 2000 | SESE |
| K993713 | RIM-FIX, ACETABULAR CUP | Surgical Implants, Inc. | Jan 28, 2000 | SESE |
| K992409 | THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ | Implex Corp. | Oct 8, 1999 | SESE |
| K992153 | PE-PLUS ACETABULAR CUP | Plus Orthopedics | Sep 23, 1999 | SESE |
| K992903 | COLOR BUFFED CEMENTED FEMORAL | Biomet, Inc. | Sep 17, 1999 | SESE |
| K992490 | B2C HIP SYSTEM | Lepine Groupe Spa. | Aug 19, 1999 | SESE |
| K991869 | COBREX HIP STEM, MODEL 01-128-XXXXX | Implex Corp. | Jul 14, 1999 | SESE |
| K991622 | 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER | Stelkast Company | Jul 14, 1999 | SESE |
| K992058 | BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM | Biomet, Inc. | Jul 1, 1999 | SESE |
| K991987 | COLOR BUFFED ANSWER CEMENTED FEMORAL | Biomet, Inc. | Jun 28, 1999 | SESE |
| K991538 | OPERA CUPFLANGED ACETABULAR COMPONENTS | Smith & Nephew, Inc., Orthopaedic Div. | Jun 3, 1999 | SESE |
| K991227 | 8MM FORGED CEMENTED STEM | Encore Orthopedics, Inc. | Jun 1, 1999 | SESE |
| K990821 | PROVIDENCE CUP SYSTEM | Biopro, Inc. | Apr 29, 1999 | SESE |
| K984227 | OMEGA II MODULAR TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | Apr 8, 1999 | SESE |
| K990369 | SYNERGY CEMENTED HIP STEM | Smith & Nephew, Inc. | Mar 12, 1999 | SESE |
| K990032 | MODULAR PROTUSIO CUP | Biomet, Inc. | Feb 18, 1999 | SESE |
| K984154 | APF POROUS COATED LINE EXTENSION | Biomet, Inc. | Feb 11, 1999 | SESE |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | Howmedica Corp. | Dec 16, 1998 | SESE |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Howmedica Corp. | Dec 11, 1998 | SESE |
| K983226 | OSTEONICS X CEMENTED HIP STEM SERIES | Osteonics Corp. | Dec 4, 1998 | SESE |
| K983128 | IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY | Implex Corp. | Dec 3, 1998 | SESE |
| K983710 | 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH | Biomet, Inc. | Dec 2, 1998 | SESE |
| K983136 | DEPUY LUSTER STEM | DePuy Orthopaedics, Inc. | Nov 25, 1998 | SESE |
| K982963 | POLYMER THREADED ANCHOR / SUTURE COMBINATION | Orthopaedic Biosystems, Ltd. | Nov 20, 1998 | SESE |
| K982918 | DEPUY C-STEM SYSTEM | DePuy Orthopaedics, Inc. | Oct 5, 1998 | SESE |
| K982670 | CONTEMPORARY ACETABULAR COMPONENT | Howmedica Corp. | Oct 2, 1998 | SESE |
| K982598 | OTI FEMORAL LOCK TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | Oct 2, 1998 | SESE |
| K974685 | OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS | Osteonics Corp. | Sep 22, 1998 | SESE |
| K981855 | PRINCE MEDICAL CEMENT PLUG | Prince Medical, Inc. | Aug 10, 1998 | SESE |
| K980813 | RELIANCE LONG STEM FEMORAL COMPONENTS | Howmedica, Inc. | Jun 26, 1998 | SESE |
| K980843 | EXETER INTRAMEDULLARY BONE PLUG | Howmedica, Inc. | Jun 2, 1998 | SESE |
| K980794 | DUAL LOCK HIP STEM | Depuy, Inc. | May 20, 1998 | SESE |
| K980513 | ARTICUL/EZE FEMORAL HEADS | DePuy Orthopaedics, Inc. | Apr 14, 1998 | SESE |
| K980486 | IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM | Implex Corp. | Apr 14, 1998 | SESE |
| K980286 | ULTIMA ACETABULAR ROOF REINFORCEMENT RING | Johnson & Johnson Professionals, Inc. | Apr 3, 1998 | SESE |
| K974558 | SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM | Biomet, Inc. | Mar 4, 1998 | SESE |
| K972791 | ENCORE LINEAR HIP | Encore Orthopedics, Inc. | Jan 12, 1998 | SN |
| K973809 | FOUNDATION FRACTURE STEM | Encore Orthopedics, Inc. | Jan 2, 1998 | SESE |
| K974054 | DISTAL CENTRALIZER, EXETER II HIP SYSTEM | Howmedica, Inc. | Dec 23, 1997 | SESE |
| K973453 | TORNIER CEMENT RESTRICTOR | Tornier | Dec 9, 1997 | SESE |
| K971681 | SMC FEMORAL HIP COMPONENT | Signal Medical Corp. | Dec 4, 1997 | SESE |
| K973296 | EXTEND HIP STEM | Wrightmedicaltechnologyinc | Nov 24, 1997 | SESE |
| K972995 | THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM | Corin USA | Nov 10, 1997 | SESE |
| K972961 | STELKAST BIPOLAR SYSTEM | Stelkast Company | Nov 4, 1997 | SESE |
| K972928 | KERBOULL CROSS | Howmedica, Inc. | Nov 3, 1997 | SN |
| K972792 | DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS | Howmedica Corp. | Oct 16, 1997 | SESE |
| K972641 | DUAL OFFSET PERFECTA IMC HIP STEM | Wrightmedicaltechnologyinc | Oct 9, 1997 | SESE |
| K972460 | OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION) | Osteonics Corp. | Sep 25, 1997 | SESE |
| K972435 | ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM | Johnson & Johnson Professionals, Inc. | Sep 11, 1997 | SESE |
| K971890 | RECOVERY PROTRUSIO CAGE | Biomet, Inc. | Aug 7, 1997 | SESE |
| K971705 | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED | Implex Corp. | Aug 6, 1997 | SESE |
| K971581 | HEMISPHERE CEMENTED CUP | Ortho Development Corp. | Jul 18, 1997 | SESE |
| K963612 | DURATION STABILIZED UHMWPE | Howmedica Corp. | Jun 11, 1997 | SESE |
| K970697 | OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | Apr 24, 1997 | SESE |
| K970194 | PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT | Stelkast Company | Apr 14, 1997 | SESE |
| K965019 | THE C-FIT FEMORAL HIP SYSTEM | Corin USA | Mar 25, 1997 | SESE |
| K964003 | METAGEN ALL POLY ACETABULAR CUP SYSTEM | Metagen, LLC | Mar 21, 1997 | SESE |
| K970351 | GLOBAL TAPER SPECTRON HIP STEMS | Smith & Nephew, Inc., Orthopaedic Div. | Feb 28, 1997 | SESE |
| K964795 | CEMENTED CALCAR REPLACEMENT FEMORAL STEM | Johnson & Johnson Professionals, Inc. | Feb 19, 1997 | SESE |
| K964655 | UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE | Howmedica Corp. | Feb 6, 1997 | SESE |
| K963671 | OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP | Osteonics Corp. | Feb 3, 1997 | SESE |
| K962468 | HEDROCEL ACETABULAR RESTRICTOR | Implex Corp. | Feb 3, 1997 | SESE |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | Intermedics Orthopedics | Jan 16, 1997 | SESE |
| K963109 | HERITAGE HIP SYSTEM | Zimmer, Inc. | Jan 9, 1997 | SESE |
| K964218 | PERFECTA PLASMA SPRAY HIP STEM | Wrightmedicaltechnologyinc | Jan 8, 1997 | SESE |
| K964262 | EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD | Exactech, Inc. | Dec 27, 1996 | SESE |
| K963486 | REVISION HIP SYSTEM | Smith & Nephew Richards, Inc. | Nov 27, 1996 | SESE |
| K963313 | EXACTECH ALL POLY ACETABULAR CUP | Exactech, Inc. | Nov 14, 1996 | SESE |
| K963206 | S-ROM HIP SYSTEM - LOCKING PLUG | Johnson & Johnson Professionals, Inc. | Oct 17, 1996 | SESE |
| K955137 | IM C-MENT ACETABULAR CAP | Implant Ideas, LLC | Oct 10, 1996 | SESE |
Top Applicants
- Biomet, Inc. — 50 clearances
- Depuy, Inc. — 45 clearances
- Howmedica Corp. — 35 clearances
- Osteonics Corp. — 29 clearances
- Zimmer, Inc. — 27 clearances