Product Code: MBH


Products Classified as MBH

4616Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymerKnee Joint Patellofemorotibial Metal/polymer Porous-coated Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4616Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymerKnee Joint Patellofemorotibial Metal/polymer Porous-coated Uncemented Prosthesis.

FDA Consensus Standards

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [37410]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [37411]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [35610]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [32800]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [31877]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [34714]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [33115]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [31869]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [38290]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [37451]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [31849]21 CFR §888.3565 ๐Ÿ”Ž
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer [33949]21 CFR §888.3565 ๐Ÿ”Ž

Pre-market Notifications for MBH

K221850GMK 3D Metal Tibial TrayMedacta International S.A.
K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroPort Orthopedics Inc.
K212941Porous PatellaEncore Medical, L.P. Dba DJO Surgical
K211221Porous Patella And Porous Tibia BaseplateSmith & Nephew, Inc.
K210566LEGION Porous CR Narrow Femoral ComponentsSmith & Nephew, Inc.
K210308EMPOWR Porous Femur With HAnano SurfaceTMEncore Medical, L.P.
K203779Symmetric Total Knee SystemSignal Medical Corporation
K202194ATTUNEยฎ Porous Fixed Bearing Tibial Base, Medialized Dome Patella, And Medialized Anatomic Patella With AFFIXIUMโ„ข 3DP TechnologyDePuy Ireland UC
K201364LINK TrabecuLink Femoral ConesWaldemar Link GmbH & Co. KG
K201084Physica SystemLimaCorporate S.p.A.
K200782Triathlon Posterior Stabilized Femoral Component - Beaded With Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - Beaded With Peri-ApatiteHowmedica Osteonics Corp.
K200113LINK TrabecuLink Tibial ConesWaldemar Link GmbH & Co. KG
K193312UNIKO PointCloudโ„ข Knee InstrumentsUnik Orthopedics, Inc.
K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC
K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (aka Stryker Orthopaedics)

Global Unique Device Identification Database

00814703014871PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014864PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014857PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014840PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014833PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014796PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014758PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014741PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014734PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014727PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014710PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014703PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014680PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014666PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
00814703014642PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Maude Adverse Events

TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE EZIMMER BIOMET, INC.2020-03-31
TRIATHLON PRIM CEM FXD BPLT #5STRYKER ORTHOPAEDICS-MAHWAH2020-03-31
TRIATHLON P/A PS BEADED #6LSTRYKER ORTHOPAEDICS-MAHWAH2020-03-31
X3 TRIATHLON CS INS SIZE 4 9MMSTRYKER ORTHOPAEDICS-MAHWAH2020-03-31
DURA DURATION A/P TIB SM 13STRYKER ORTHOPAEDICS-MAHWAH2020-03-31
X3 TRIATHLON CS INSERT #6 9MMSTRYKER ORTHOPAEDICS-MAHWAH2020-03-31
CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-12 GH TOPZIMMER BIOMET, INC.2020-03-30
ALL POLY PATELLA CEMENTED 35 MM DIAMETERZIMMER MANUFACTURING B.V.2020-03-30
TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE GZIMMER ORTHOPAEDIC MFG. LTD.2020-03-30
ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENTZIMMER MANUFACTURING B.V.2020-03-30
FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 11ZIMMER ORTHOPAEDIC MFG. LTD.2020-03-30
UNKNOWN_SIZE 6 PS FEMURSTRYKER ORTHOPAEDICS-MAHWAH2020-03-30
X3 TRIATHLON INSERT CS#4 9MMESTRYKER ORTHOPAEDICS-MAHWAH2020-03-30
UNKNOWN_SIZE 5 PRIMARY BASEPLATESTRYKER ORTHOPAEDICS-MAHWAH2020-03-30
NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MMSTRYKER ORTHOPAEDICS-MAHWAH2020-03-30
TRIATHLON PS FEM COMPONENT, CEMENTEDSTRYKER ORTHOPAEDICS-MAHWAH2020-03-30
TRIATHLON PS X3 TIBIAL INSERTSTRYKER ORTHOPAEDICS-MAHWAH2020-03-30
NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MMSTRYKER ORTHOPAEDICS-MAHWAH2020-03-30
X3 TRIATHLON CS INSERT #6 13MMSTRYKER ORTHOPAEDICS-MAHWAH2020-03-30
NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE FZIMMER BIOMET, INC.2020-03-26
TRIATHLON P/A CR BEADED #4RSTRYKER ORTHOPAEDICS-MAHWAH2020-03-26
TRIATHLON PS X3 TIBIAL INSERTSTRYKER ORTHOPAEDICS-MAHWAH2020-03-26
NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MMSTRYKER ORTHOPAEDICS-MAHWAH2020-03-26
PROFIX {} C/R HA POR FEM SZ 5 LTSMITH & NEPHEW, INC.2020-03-25
TRITANIUM BPLATE TRIATHLON S5STRYKER ORTHOPAEDICS-MAHWAH2020-03-25
ALL POLY PATELLA CEMENTED 35 MM DIAMETERZIMMER MANUFACTURING B.V.2020-03-25
TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EFZIMMER BIOMET, INC.2020-03-24
TRIATHLON PRIM TIB BASEPLATE - CEMENTEDSTRYKER ORTHOPAEDICS-MAHWAH2020-03-24
ADVANCE?PRESS FIT KEEL PRIMARY 15MM X SIZE 1/1+/2MICROPORT ORTHOPEDICS INC.2020-03-24
X3 TRIATHLON CS INS SIZE 4 9MMSTRYKER ORTHOPAEDICS-MAHWAH2020-03-24
TRITANIUM BPLATE TRIATHLON S4STRYKER ORTHOPAEDICS-MAHWAH2020-03-24
UNKNOWN_STRYKER KNEE SYSTEMSTRYKER ORTHOPAEDICS-MAHWAH2020-03-24
ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHTZIMMER ORTHOPAEDIC MFG. LTD.2020-03-23
UNKNOWN TRIATHLON TKASTRYKER ORTHOPAEDICS-MAHWAH2020-03-23
UNKNOWN_4X13MM TS INSERTSTRYKER ORTHOPAEDICS-MAHWAH2020-03-23
X3 TRIATHLON CS INS SIZE 4 9MMSTRYKER ORTHOPAEDICS-MAHWAH2020-03-23
TRIATHLON PS X3 TIBIAL INSERTSTRYKER ORTHOPAEDICS-MAHWAH2020-03-23
UNKNOWN_ STRYKER INSERTSTRYKER ORTHOPAEDICS-MAHWAH2020-03-23
TRIATHLON P/A CR BEADED #5RSTRYKER ORTHOPAEDICS-MAHWAH2020-03-23
UNKNOWN_UNKNOWN STRYKER KNEESTRYKER ORTHOPAEDICS-MAHWAH2020-03-23
MC TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 8-11 GH TOPZIMMER BIOMET, INC.2020-03-23
SIG C/R POROCOAT FEM LT SZ 3DEPUY ORTHOPAEDICS INC US2020-03-23
TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EFZIMMER BIOMET, INC.2020-03-23
UNKNOWN STRYKER KNEESTRYKER ORTHOPAEDICS-MAHWAH2020-03-20
TRITANIUM BPLATE TRIATHLON S4STRYKER ORTHOPAEDICS-MAHWAH2020-03-20
UNKNOWN TRIATHLON KNEE INSERTSTRYKER ORTHOPAEDICS-MAHWAH2020-03-19
TRIATHLON P/A CR BEADED #3RSTRYKER ORTHOPAEDICS-MAHWAH2020-03-18
ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 10 MM HEIGHTZIMMER ORTHOPAEDIC MFG. LTD.2020-03-18
ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT 12 MM HEIGHTZIMMER BIOMET, INC.2020-03-18
CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 10 MM THICKNESSZIMMER BIOMET, INC.2020-03-18

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