MEH · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Orthopedic · 21 CFR 888.3353 · Class 2
Overview
| Product Code | MEH |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| 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 (159)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | Nov 5, 2025 | SESE |
| K251166 | Mfinity Femoral System | Medacta International S.A. | Jun 13, 2025 | SESE |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | May 22, 2025 | SESE |
| K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | May 1, 2025 | SESE |
| K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | Mar 10, 2025 | SESE |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | Nov 25, 2024 | SESE |
| K241472 | Icona Hip Stem | Corin U.S.A. Limited | Oct 3, 2024 | SESE |
| K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | Sep 13, 2024 | SESE |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | Aug 1, 2024 | SESE |
| K233758 | Trivicta Hip Stem | Ortho Development Corp. | Mar 8, 2024 | SESE |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional | Depuy Ireland UC | Jan 19, 2024 | SESE |
| K231178 | ACTERA hip system | Conformis, Inc. | May 23, 2023 | SESE |
| K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | Jan 13, 2023 | SESE |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | Aug 11, 2022 | SESE |
| K221104 | Actera hip system | Conformis, Inc. | Aug 4, 2022 | SESE |
| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | Jan 7, 2022 | SESE |
| K211505 | Encore Hip Stem | Signature Orthopaedics Pty, Ltd. | Sep 24, 2021 | SESE |
| K211703 | Insignia Hip Stem | Stryker Orthopaedics | Aug 16, 2021 | SESE |
| K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | May 20, 2021 | SESE |
| K200045 | MUTARS Cemented Femoral Stems | Implantcast GmbH | Oct 16, 2020 | SESE |
| K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty, Ltd. | Sep 21, 2020 | SESE |
| K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | Feb 4, 2020 | SESE |
| K181778 | MUTARS Proximal Femur Replacement System | Implantcast GmbH | Mar 25, 2019 | SESE |
| K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | Apr 11, 2018 | SESE |
| K171273 | LINK® BiMobile(TM) Dual Mobility System | Waldemar Link GmbH & Co. KG | Jan 19, 2018 | SESE |
| K171249 | Entrada hip stem | Ortho Development Corporation | Aug 24, 2017 | SESE |
| K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | May 1, 2017 | SESE |
| K162732 | Exactech® Alteon® HA Femoral Stem | Exactech, Inc. | Apr 26, 2017 | SESE |
| K153649 | Exactech® Novation® Element Press-fit Femoral Stem | Exactech, Inc. | Aug 31, 2016 | SESE |
| K160011 | H-Max S stem | Lima Corporate S.P.A. | Aug 22, 2016 | SESE |
| K161155 | Origin Coxa Vara Hip Stem | Signature Orthopaedics Pty, Ltd. | Jul 19, 2016 | SESE |
| K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy(Ireland) | Jul 19, 2016 | SESE |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner | Signature Orthopaedics Pty, Ltd. | Jun 3, 2016 | SESE |
| K153772 | Corin TriFit TS Hip | Corin U.S.A. Limited | Mar 31, 2016 | SESE |
| K150855 | H-MAX S Femoral Hip System | Lima Corporate S.P.A. | Oct 21, 2015 | SESE |
| K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | Sep 25, 2015 | SESE |
| K122853 | NOVEL FIT AND FILL STEM | Howmedica Osteonics Corp. | Feb 1, 2013 | SESE |
| K112091 | H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS | Lima Corporate S.P.A. | Nov 9, 2012 | SESE |
| K121627 | SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM | Smith & Nephew, Inc. | Oct 15, 2012 | SESE |
| K121563 | CORIN TRIFIT TS HIP | Corin USA | Oct 5, 2012 | SESE |
| K113039 | SMITH & NEPHEW RADIOPAQUE TRIAL NECKS | Smith & Nephew, Inc. | Oct 5, 2012 | SESE |
| K113789 | MODULAR PROXIMALLY FLUTED HIP STEM | Smith & Nephew, Inc. | Apr 19, 2012 | SESE |
| K113320 | NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 | Exactech, Inc. | Mar 16, 2012 | SESE |
| K113107 | MSA HIP SYSTEM | Global Manufacturing Technology | Dec 15, 2011 | SESE |
| K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS | Howmedica Osteonics Corp. | Sep 28, 2011 | SESE |
| K103479 | NOVEL TAPERED HIP STEM | Stryker Corp. | Mar 10, 2011 | SESE |
| K103497 | CERAMIC FEMORAL HEAD | United Orthopedic Corp. | Mar 4, 2011 | SESE |
| K102172 | MSA HIP SYSTEM | Global Manufacturing Technology | Mar 1, 2011 | SESE |
| K102424 | PREVISION HIP SYSTEM WITH RECON RING | Aesculap Implant Systems, LLC | Dec 9, 2010 | SESE |
| K093472 | TRINITY ACETABULAR SYSTEM | Corin USA | Nov 23, 2010 | SESE |
| K100481 | SMITH & NEPHEW MDF MODULAR SLEEVE | Smith & Nephew, Inc. | Jul 15, 2010 | SESE |
| K090982 | SMITH & NEPHEW HIP SYSTEMS WITH HA | Smith & Nephew, Inc. | Apr 21, 2010 | SESE |
| K092265 | VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS | Medacta International S.A. | Mar 12, 2010 | SESE |
| K093644 | RESTORATION ADM SYSTEM X3 ACETABULAR | Howmedica Osteonics Corp. | Dec 18, 2009 | SESE |
| K092406 | ABG II MODULAR HIP STEM | Howmedica Osteonics Corp. | Nov 4, 2009 | SESE |
| K092561 | REJUVENATE MODULAR STEM | Howmedica Osteonics Corp. | Oct 20, 2009 | SESE |
| K092143 | EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM | Aesculap Implant Systems, Inc. | Sep 22, 2009 | SESE |
| K091161 | REJUVENATE MONOLITHIC SIZE 4 HIP STEM | Howmedica Osteonics Corp. | Jun 16, 2009 | SESE |
| K083116 | VERSAFIT CUP DOUBLE MOBILITY SYSTEM | Medacta International S.A. | Apr 7, 2009 | SESE |
| K082892 | REJUVENATE MONOLITHIC HIP SYSTEM | Howmedica Osteonics Corp. | Dec 29, 2008 | SESE |
| K081124 | MDF REVISION HIP SYSTEM | Smith & Nephew, Inc. | Jul 31, 2008 | SESE |
| K081044 | REJUVENATE MODULAR HIP SYSTEM | Howmedica Osteonics Corp. | Jun 3, 2008 | SESE |
| K071916 | METHA HIP SYSTEM | Aesculap Implant Systems, Inc. | Jun 2, 2008 | SESE |
| K080584 | METHA SHORT STEM HIP SYSTEM | Aesculap Implant System, Inc. | May 9, 2008 | SESE |
| K080980 | EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS | Exactech, Inc. | May 6, 2008 | SESE |
| K072020 | RESTORATION ADM SYSTEM | Howmedica Osteonics Corp. | Oct 18, 2007 | SESE |
| K071583 | CERMET III ACETABULAR CUP SYSTEM | Implants International, Ltd. | Jul 25, 2007 | SESE |
| K060437 | EXCIA TOTAL HIP SYSTEM WITH U-CAP | Aesculap, Inc. | Mar 22, 2006 | SESE |
| K053528 | SHORT CITATION FEMORAL STEM | Stryker Orthopaedics | Jan 13, 2006 | SESE |
| K052426 | SMITH & NEPHEW MODULAR HIP | Smith & Nephew, Inc. | Dec 7, 2005 | SESE |
| K043079 | BICONTACT HIP SYSTEM WITH U-CAP | Aesculap | Dec 8, 2004 | SESE |
| K042127 | SMITH & NEPHEW MODULAR HIP | Smith & Nephew, Inc. | Nov 19, 2004 | SESE |
| K041353 | FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM | Jri Manufacturing, Ltd. | Oct 8, 2004 | SESE |
| K040680 | CONTOUR HA COATED RECONSTRUCTION RING | Smith & Nephew, Inc. | Jun 14, 2004 | SESE |
| K040613 | EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS | Exactech, Inc. | Jun 4, 2004 | SESE |
| K032641 | MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM | Portland Orthopaedics Pty. , Ltd. | Jan 20, 2004 | SESE |
| K032300 | ACCOLADE-J HIP STEM SERIES | Howmedica Osteonics Corp. | Oct 9, 2003 | SESE |
| K023302 | ECHELON POROUS PLUS HA HIP STEMS | Smith & Nephew, Inc. | Oct 25, 2002 | SESE |
| K023102 | ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM | Howmedica Osteonics Corp. | Oct 9, 2002 | SESE |
| K021403 | HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM | Biomet Orthopedics, Inc. | May 31, 2002 | SESE |
| K020615 | SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS | Howmedica Osteonics Corp. | May 13, 2002 | SESE |
| K021108 | ESOP HA FEMORAL STEM | Fournitures Hospitalieres | May 3, 2002 | SESE |
| K020963 | TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM | Biomet Orthopedics, Inc. | Apr 16, 2002 | SESE |
| K020572 | ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM | Howmedica Osteonics Corp. | Mar 4, 2002 | SESE |
| K013676 | TRIDENT HEMISPHERICAL ACETABULAR SHELLS | Howmedica Osteonics Corp. | Dec 5, 2001 | SESE |
| K002996 | SYNERGY HA COATED POROUS FEMORAL STEMS | Smith & Nephew, Inc. | Dec 11, 2000 | SESE |
| K001580 | GROSS FEMORAL COMPONENT | Biomet, Inc. | Aug 17, 2000 | SESE |
| K001448 | TRIDENT ACETABULAR SHELLS: PS-HA | Howmedica Osteonics Corp. | Aug 4, 2000 | SESE |
| K000262 | BOHN FEMORAL COMPONENT | Biomet Manufacturing, Inc. | Apr 3, 2000 | SESE |
| K994366 | TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM | Howmedica Osteonics Corp. | Mar 16, 2000 | SESE |
| K000242 | ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE | Exactech, Inc. | Feb 16, 2000 | SESE |
| K992815 | THE MARGRON HIP REPLACEMENT SYSTEM | Portland Orthopaedics Pty. , Ltd. | Feb 7, 2000 | SESE |
| K993943 | ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA | Encore Orthopedics, Inc. | Feb 4, 2000 | SESE |
| K993768 | CITATION TMZF HA STEM | Howmedica Osteonics Corp. | Jan 21, 2000 | SESE |
| K993077 | HOWMEDICA OSTEONICS RESTORATION HA HIP STEM | Howmedica Osteonics Corp. | Oct 8, 1999 | SESE |
| K992025 | PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING | Howmedica Osteonics Corp. | Aug 13, 1999 | SESE |
| K990666 | HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL | Smith & Nephew, Inc. | Aug 6, 1999 | SESE |
| K980070 | OSTEONICS HA-COATED DEVICES | Osteonics Corp. | Jul 23, 1999 | SESE |
| K990203 | OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | Osteonics Corp. | Feb 18, 1999 | SESE |
| K990197 | MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM | Exactech, Inc. | Feb 4, 1999 | SESE |
| K983382 | OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | Dec 11, 1998 | SESE |
| K983870 | OSTEONICS RESTORATION HA HIP STEMS | Osteonics Corp. | Dec 2, 1998 | SN |
| K982032 | OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | Osteonics Corp. | Jul 9, 1998 | SESE |
| K980766 | OSTEONICS ANTEVERTED NECK HA HIP STEMS | Osteonics Corp. | May 27, 1998 | SESE |
| K964878 | ESOP S/C FEMORAL STEM | Fournitures Hospitalieres | Mar 5, 1998 | SN |
| K971523 | DISTALLY FIXED HIP STEM | Sulzer Orthopedics, Inc. | Oct 1, 1997 | SN |
| K961732 | KAR | Landos, Inc. | Jul 8, 1997 | SESE |
| K971422 | OSTEONICS ACETABULAR WEDGE SYSTEM | Osteonics Corp. | May 22, 1997 | SN |
| K970394 | OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | Apr 22, 1997 | SESE |
| K961388 | ATLAS III ACETABULAR CUP | Fournitures Hospitalieres | Apr 3, 1997 | SESE |
| K970337 | HA GLOBAL TAPER (GT) TAPERED HIP STEM | Smith & Nephew, Inc., Orthopaedic Div. | Feb 28, 1997 | SESE |
| K963959 | OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION) | Osteonics Corp. | Dec 19, 1996 | SESE |
| K954800 | APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) | Intermedics Orthopedics | Apr 25, 1996 | SN |
| K955305 | PCA +15MM MODULAR FEMORAL HEAD | Howmedica Corp. | Jan 18, 1996 | SESE |
| K951517 | OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES | Osteonics Corp. | Jan 17, 1996 | SN |
| K954023 | OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | Nov 22, 1995 | SESE |
| K951671 | OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES | Osteonics Corp. | Sep 6, 1995 | SESE |
| K951932 | OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES | Osteonics Corp. | Sep 1, 1995 | SESE |
| K951291 | OSTEONICS RESTORATION MONOLITHIC HIP STEM | Osteonics Corp. | Aug 9, 1995 | SN |
| K941366 | OSTEONICS OMNIFIT AD-HA HIP STEM SERIES | Osteonics Corp. | Jun 6, 1995 | SESE |
| K945844 | DEPUY CDH PROSTHESIS | Depuy, Inc. | May 25, 1995 | SESE |
| K946234 | OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES | Osteonics Corp. | Apr 10, 1995 | SESE |
| K944836 | OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES | Osteonics Corp. | Apr 10, 1995 | SN |
| K945691 | OSTEONICS(R) THREADED HA ACETABULAR SHELLS | Osteonics Corp. | Mar 17, 1995 | SN |
| K942900 | OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | Mar 15, 1995 | SESE |
| K943957 | RESTORATION HA ACETABULAR CUP SERIES | Osteonics Corp. | Mar 6, 1995 | SN |
| K942891 | SUMMIT TOTAL HIP SYSTEM | Kirschner Medical Corp. | Nov 2, 1994 | SESE |
| K932017 | TECHMEDICA CONTINUUM HIP WITH HA COATING | Techmedica, Inc. | Sep 1, 1994 | SESE |
| K935696 | ETEX HA HIP REPLACEMENT SYSTEM | Etex Corp. | Jul 22, 1994 | SN |
| K934729 | UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED | Implantology Corp. | Jul 22, 1994 | SN |
| K935990 | F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM | Implex Corp. | Jul 13, 1994 | SN |
| K935453 | CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM | U.S. Medical Products, Inc. | Jul 13, 1994 | SN |
| K922613 | CL HIP STEM H/A COATED | Lima Intl. Corp. | Apr 5, 1994 | SN |
| K922621 | HA TI-FIT ACETABULAR AND FEMORAL COMPONENT | Smith & Nephew Richards, Inc. | Mar 17, 1994 | SN |
| K915655 | STABILITY FEMORAL PROSTHESIS W/HAP | Depuy, Inc. | Feb 14, 1994 | SESE |
| K925607 | HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE | Zimmer, Inc. | Nov 8, 1993 | SN |
| K926299 | CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING | Depuy, Inc. | Oct 22, 1993 | SESE |
| K926134 | H-220 PRESS-FIT ACETABULAR CUP SYSTEM | Implex Corp. | Oct 15, 1993 | SESE |
| K920969 | HYDROXYLAPATITE INFINITY(R) | Dow Corning Wright | May 5, 1993 | SESE |
| K915190 | PERFECTA TOTAL HIP SYSTEM, HA COATED | Orthomet, Inc. | Dec 24, 1992 | SESE |
| K921672 | INTER-HA HIP PROSTHESIS | Kirschner Medical Corp. | Aug 7, 1992 | SESE |
| K915617 | LSF HA COATED FEMORAL HIP | Implant Technology, Inc. | May 28, 1992 | SESE |
| K915350 | HYDROXYAPATITE INFINITY TROCHANTERIC MODULE | Dow Corning Wright | Feb 3, 1992 | SESE |
| K914843 | KINAMED ATH-HA & ATH-HA LONG TOTAL HIP | Kinamed, Inc. | Feb 3, 1992 | SESE |
| K912713 | S-ROM ZT HA PROXIMAL FEMORAL SLEEVE | Joint Medical Products Corp. | Dec 30, 1991 | SN |
| K913916 | HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT | Smith & Nephew Richards, Inc. | Dec 9, 1991 | SESE |
| K912370 | HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES) | Biomet, Inc. | Oct 11, 1991 | SESE |
| K912369 | HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) | Biomet, Inc. | Oct 11, 1991 | SESE |
| K912922 | DIMENSION-HA HIP PROSTHESIS | Kirschner Medical Corp. | Oct 4, 1991 | SESE |
| K912452 | HA MCCUTCHEN SLT HIP SYSTEM | Dow Corning Wright | Oct 4, 1991 | SESE |
| K912263 | HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC | Zimmer, Inc. | Aug 29, 1991 | SESE |
| K912654 | OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP | Osteonics Corp. | Aug 16, 1991 | SESE |
| K911728 | OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C | Osteonics Corp. | Aug 16, 1991 | SESE |
| K912395 | HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT | Howmedica Corp. | Jul 24, 1991 | SN |
| K911585 | OMNIFIT II EPF HIP STEM SERIES | Osteonics Corp. | Jul 1, 1991 | SESE |
| K910156 | HYDROXYAPATITE COATED PROFILE(R) HIP STEM | Depuy, Inc. | Jun 7, 1991 | SESE |
| K910755 | PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING | Intermedics Orthopedics | Mar 26, 1991 | SESE |
| K905781 | APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM | Intermedics Orthopedics | Mar 4, 1991 | SESE |
| K896047 | THE OMNIFIT EPF HIP JOINT FEMORAL STEM | Osteonics Corp. | Dec 20, 1990 | SN |
Top Applicants
- Osteonics Corp. — 24 clearances
- Howmedica Osteonics Corp. — 19 clearances
- Smith & Nephew, Inc. — 13 clearances
- Signature Orthopaedics Pty, Ltd. — 8 clearances
- Exactech, Inc. — 8 clearances
