Product Code: HSX


Products Classified as HSX

4474Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymerKnee Joint Femorotibial Metal/polymer Non-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4474Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymerKnee Joint Femorotibial Metal/polymer Non-constrained Cemented Prosthesis.

FDA Consensus Standards

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [34059]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [38231]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [37410]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [37411]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [32800]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [31877]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [33508]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [34714]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [32210]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [33115]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [31869]21 CFR §888.3520 🔎
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer [38290]21 CFR §888.3520 🔎

Pre-market Notifications for HSX

K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.
K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.
K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.
K203341ACS LD Uni FB Knee SystemImplantcast GmbH
K202207Materialise PKA Guide SystemMaterialise NV
K200433IBalance UKA Tibial Tray ImplantArthrex Inc.
K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial RecutterZimmer, Inc.
K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.
K191325EMPOWR Partial KneeEncore Medical, L.P.
K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.
K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.
K190085Journey II Unicompartmental Knee SystemSmith & Nephew Inc
K183029MOTO Partial Knee SystemMedacta International SA
K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories Inc.
K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp Aka Stryker Orthopaedics

Global Unique Device Identification Database

00885556738146PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556735718PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556735701PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556731574PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556731444PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556731321PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556726075PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556726068PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556718865PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556718742PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556718384PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556718377PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556717264PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556717257PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
00885556717240PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Maude Adverse Events

PERSONA PARTIAL KNEE ARTICULAR SURFACE RIGHT MEDIAL SIZE E 8MMZIMMER BIOMET, INC.2020-03-25
PERSONA PARTIAL KNEE CEMENTED FEMUR SIZE 4 RIGHT MEDIALZIMMER BIOMET, INC.2020-03-25
ARTICULAR SURFACE SIZE 4 9 MM HEIGHTZIMMER BIOMET, INC.2020-03-23
TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 4ZIMMER BIOMET, INC.2020-03-23
FEMORAL COMPONENT HIGH FLEX PRECOAT FORZIMMER BIOMET, INC.2020-03-23
MINI CONNECTORSMITH & NEPHEW, INC.2020-03-17
FEMORAL IMPACTORSMITH & NEPHEW, INC.2020-03-06
GENESIS UNI FEMORAL LARGESMITH & NEPHEW, INC.2020-03-04
MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MMMEDACTA INTERNATIONAL SA2020-03-04
MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MMMEDACTA INTERNATIONAL SA2020-03-03
PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIALZIMMER BIOMET, INC.2020-02-27
MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 LM - 9MMMEDACTA INTERNATIONAL SA2020-02-21
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RMMEDACTA INTERNATIONAL SA2020-02-20
JOURNEY UNI TIBINRT S5-6RM/LL11MMSMITH & NEPHEW, INC.2020-02-19
HP FEM IMP/EXTDEPUY ORTHOPAEDICS INC US2020-02-17
ACCURIS TIBIAL INSERT HANDLESMITH & NEPHEW, INC.2020-02-17
JOURNEY UNI TIB TR INS SZ3-4/9MMSMITH & NEPHEW, INC.2020-02-17
JRNY UNI TIBIAL IMPACTORSMITH & NEPHEW, INC.2020-02-13
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RMMEDACTA INTERNATIONAL SA2020-02-12
MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 RM - 8MMMEDACTA INTERNATIONAL SA2020-02-11
PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIALZIMMER BIOMET, INC.2020-02-05
MOTO PARTIAL KNEE TIBIAL INSERT FIX S6 RM - 8MMMEDACTA INTERNATIONAL SA2020-02-04
PERSONA PARTIAL FEMUR CEMENTED SIZE 5 RIGHT MEDIALZIMMER BIOMET, INC.2020-01-28
PERSONA PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIALZIMMER BIOMET, INC.2020-01-28
PERSONA PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE E 8 MMZIMMER BIOMET, INC.2020-01-28
PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIALZIMMER ORTHOPAEDIC MFG. LTD.2020-01-23
JRNY UNI TIBIAL IMPACTORSMITH & NEPHEW, INC.2020-01-21
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 RMMEDACTA INTERNATIONAL SA2020-01-08
PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE F 11 MM THICKNESSZIMMER BIOMET, INC.2019-12-30
JRNY UNI TIBIAL BASE RM/LL SZ 2SMITH & NEPHEW, INC.2019-12-23
JOURNEY UNI TIBINRT S3-4LM/RL8MMSMITH & NEPHEW, INC.2019-12-17
JOURNEY UNI TIBINRT S5-6LM/RL8MMSMITH & NEPHEW, INC.2019-12-11
4.8 MM QUICK CONNECT DRILL BITSMITH & NEPHEW, INC.2019-12-09
JOURNEY UNI TIBINRT S3-4LM/RL9MMSMITH & NEPHEW, INC.2019-12-02
JOURNEY UNI TIB BASE LM/RL SZ 4SMITH & NEPHEW, INC.2019-11-29
PARTIAL TIBIAL CEMENTED SIZE E LEFT MEDIALZIMMER BIOMET, INC.2019-11-27
PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIALZIMMER BIOMET, INC.2019-11-20
PWR ADAPTER-SMALL AO MALESMITH & NEPHEW, INC.2019-11-13
ZIMMER UNICOMPARTMENTAL PRECOAT TIBIAL COMPONENT SIZE 4ZIMMER BIOMET, INC.2019-11-11
ZIMMER UNICOMPARTMENTAL HIGH FLEX PRECOAT FEMORAL COMPONENT SIZE FZIMMER BIOMET, INC.2019-11-11
JOURNEY UNI TIBINRT S3-4RM/LL8MMSMITH & NEPHEW, INC.2019-10-29
JUNI OX FB FEM SZ 4 RM LLSMITH & NEPHEW, INC.2019-10-29
JRNY UNI TIBIAL BASE RM/LL SZ 4SMITH & NEPHEW, INC.2019-10-29
MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 9MMMEDACTA INTERNATIONAL SA2019-10-29
PARTIAL TIBIAL CEMENTED SIZE D RIGHT MEDIALZIMMER ORTHOPAEDIC MFG. LTD.2019-10-22
PARTIAL ARTICULAR SURFACE RIGHT MEDIALZIMMER BIOMET, INC.2019-10-22
PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIALZIMMER ORTHOPAEDIC MFG. LTD.2019-10-15
PARTIAL FEMUR CEMENTED SIZE 4 RIGHT MEDIALZIMMER BIOMET, INC.2019-10-15
PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE E 8 MM THICKNESSZIMMER BIOMET, INC.2019-10-15
PARTIAL FEMUR CEMENTED SIZE 4 RIGHT MEDIALZIMMER BIOMET, INC.2019-10-15

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