BEUDAMED
    Product Code: MEH FDA class 2 21 CFR 888.3353

    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

    Orthopedic

    The semi-constrained uncemented non-porous calcium phosphate-coated metal/polymer hip prosthesis is an orthopedic implant used to replace the hip joint, utilizing a calcium phosphate surface treatment to promote bone bonding without the use of bone cement. It is classified as FDA Class II under 21 CFR 888.3353 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MEH and it carries an implant flag. Full GMP quality system requirements apply.

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    510(k)s
    158
    FEI Numbers
    191
    Registration Numbers
    191
    Unique Applicants
    71
    Years Active
    34

    Basic Information

    Product Code
    MEH
    Device Class
    FDA class 2
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 158 510(k) clearances via K numbers.

    K Number Device Name
    K251166 Mfinity Femoral System
    K251052 Trivicta® Hip Stem
    K242315 Resolve Modular Revision Hip Stem
    K243839 Alteon® HA Femoral Stems
    K243162 World Liner
    K241472 Icona Hip Stem
    K241875 TheRay Collared and Collarless Femoral Stem
    K241690 Logical Liner; World Liner; World Knee Patella
    K233758 Trivicta™ Hip Stem
    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
    K231178 ACTERA™ hip system
    K220495 SignaSure Dual Mobility System
    K220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
    K221104 Actera™ hip system
    K211742 SignaSure Dual Mobility System
    K211505 Encore Hip Stem
    K211703 Insignia Hip Stem
    K210581 Actis DuoFix Hip Prosthesis- Collarless
    K200045 MUTARS Cemented Femoral Stems
    K201278 World Hip Stem, World Cup, World Liner
    K193398 Summit DuoFix HA Coating
    K181778 MUTARS Proximal Femur Replacement System
    K173880 Corin TriFit CF Hip Stem
    K171273 LINK® BiMobile(TM) Dual Mobility System
    K171249 Entrada™ hip stem
    K162303 REDAPT Sleeved Monolithic Revision Stems
    K162732 Exactech® Alteon® HA Femoral Stem
    K153649 Exactech® Novation® Element Press-fit Femoral Stem
    K160011 H-Max S stem
    K161155 Origin Coxa Vara Hip Stem
    K160907 DePuy Actis DuoFix Hip Prosthesis
    K153131 Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
    K153772 Corin TriFit TS Hip
    K150855 H-MAX S Femoral Hip System
    K150862 DePuy Actis Duofox Hip Prosthesis
    K122853 NOVEL FIT AND FILL STEM
    K112091 H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
    K121627 SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
    K121563 CORIN TRIFIT TS HIP
    K113039 SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
    K113789 MODULAR PROXIMALLY FLUTED HIP STEM
    K113320 NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
    K113107 MSA HIP SYSTEM
    K112556 ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
    K103479 NOVEL TAPERED HIP STEM
    K103497 CERAMIC FEMORAL HEAD
    K102172 MSA HIP SYSTEM
    K102424 PREVISION HIP SYSTEM WITH RECON RING
    K093472 TRINITY ACETABULAR SYSTEM
    K100481 SMITH & NEPHEW MDF MODULAR SLEEVE
    K090982 SMITH & NEPHEW HIP SYSTEMS WITH HA
    K092265 VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS
    K093644 RESTORATION ADM SYSTEM X3 ACETABULAR
    K092406 ABG II MODULAR HIP STEM
    K092561 REJUVENATE MODULAR STEM
    K092143 EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
    K091161 REJUVENATE MONOLITHIC SIZE 4 HIP STEM
    K083116 VERSAFIT CUP DOUBLE MOBILITY SYSTEM
    K082892 REJUVENATE MONOLITHIC HIP SYSTEM
    K081124 MDF REVISION HIP SYSTEM
    K081044 REJUVENATE MODULAR HIP SYSTEM
    K071916 METHA HIP SYSTEM
    K080584 METHA SHORT STEM HIP SYSTEM
    K080980 EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
    K072020 RESTORATION ADM SYSTEM
    K071583 CERMET III ACETABULAR CUP SYSTEM
    K060437 EXCIA TOTAL HIP SYSTEM WITH U-CAP
    K053528 SHORT CITATION FEMORAL STEM
    K052426 SMITH & NEPHEW MODULAR HIP
    K043079 BICONTACT HIP SYSTEM WITH U-CAP
    K042127 SMITH & NEPHEW MODULAR HIP
    K041353 FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
    K040680 CONTOUR HA COATED RECONSTRUCTION RING
    K040613 EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
    K032641 MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
    K032300 ACCOLADE-J HIP STEM SERIES
    K023302 ECHELON POROUS PLUS HA HIP STEMS
    K023102 ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
    K021403 HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
    K020615 SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
    K021108 ESOP HA FEMORAL STEM
    K020963 TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
    K020572 ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
    K013676 TRIDENT HEMISPHERICAL ACETABULAR SHELLS
    K002996 SYNERGY HA COATED POROUS FEMORAL STEMS
    K001580 GROSS FEMORAL COMPONENT
    K001448 TRIDENT ACETABULAR SHELLS: PS-HA
    K000262 BOHN FEMORAL COMPONENT
    K994366 TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
    K000242 ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
    K992815 THE MARGRON HIP REPLACEMENT SYSTEM
    K993943 ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA
    K993768 CITATION TMZF HA STEM
    K993077 HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
    K992025 PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
    K990666 HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
    K980070 OSTEONICS HA-COATED DEVICES
    K990203 OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
    K990197 MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
    K983382 OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
    K983870 OSTEONICS RESTORATION HA HIP STEMS
    K982032 OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
    K980766 OSTEONICS ANTEVERTED NECK HA HIP STEMS
    K964878 ESOP S/C FEMORAL STEM
    K971523 DISTALLY FIXED HIP STEM
    K961732 KAR
    K971422 OSTEONICS ACETABULAR WEDGE SYSTEM
    K970394 OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
    K961388 ATLAS III ACETABULAR CUP
    K970337 HA GLOBAL TAPER (GT) TAPERED HIP STEM
    K963959 OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
    K954800 APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
    K955305 PCA +15MM MODULAR FEMORAL HEAD
    K951517 OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES
    K954023 OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM
    K951671 OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
    K951932 OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
    K951291 OSTEONICS RESTORATION MONOLITHIC HIP STEM
    K941366 OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
    K945844 DEPUY CDH PROSTHESIS
    K946234 OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
    K944836 OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
    K945691 OSTEONICS(R) THREADED HA ACETABULAR SHELLS
    K942900 OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM
    K943957 RESTORATION HA ACETABULAR CUP SERIES
    K942891 SUMMIT TOTAL HIP SYSTEM
    K932017 TECHMEDICA CONTINUUM HIP WITH HA COATING
    K935696 ETEX HA HIP REPLACEMENT SYSTEM
    K934729 UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED
    K935990 F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM
    K935453 CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM
    K922613 CL HIP STEM H/A COATED
    K922621 HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
    K915655 STABILITY FEMORAL PROSTHESIS W/HAP
    K925607 HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE
    K926299 CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING
    K926134 H-220 PRESS-FIT ACETABULAR CUP SYSTEM
    K920969 HYDROXYLAPATITE INFINITY(R)
    K915190 PERFECTA TOTAL HIP SYSTEM, HA COATED
    K921672 INTER-HA HIP PROSTHESIS
    K915617 LSF HA COATED FEMORAL HIP
    K915350 HYDROXYAPATITE INFINITY TROCHANTERIC MODULE
    K914843 KINAMED ATH-HA & ATH-HA LONG TOTAL HIP
    K912713 S-ROM ZT HA PROXIMAL FEMORAL SLEEVE
    K913916 HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
    K912370 HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
    K912369 HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
    K912922 DIMENSION-HA HIP PROSTHESIS
    K912452 HA MCCUTCHEN SLT HIP SYSTEM
    K912263 HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
    K912654 OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
    K911728 OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
    K912395 HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
    K911585 OMNIFIT II EPF HIP STEM SERIES
    K910156 HYDROXYAPATITE COATED PROFILE(R) HIP STEM
    K910755 PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING
    K905781 APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM
    K896047 THE OMNIFIT EPF HIP JOINT FEMORAL STEM

    FEI Numbers

    This FDA classification entry is associated with 191 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 191 registration numbers. Click on an entry to view related FDA registrations.