Product Code: NPJ


Products Classified as NPJ

4646Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymerKnee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4646Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymerKnee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis.

FDA Consensus Standards

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [34059]21 CFR §888.3560 🔎
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [38231]21 CFR §888.3560 🔎
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [37410]21 CFR §888.3560 🔎
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [37411]21 CFR §888.3560 🔎
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [33508]21 CFR §888.3560 🔎
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [32210]21 CFR §888.3560 🔎
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [32380]21 CFR §888.3560 🔎
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [33509]21 CFR §888.3560 🔎
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [33949]21 CFR §888.3560 🔎
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [32381]21 CFR §888.3560 🔎

Pre-market Notifications for NPJ

K150307RESTORIS Multicompartmental Knee SystemMAKO SURGICAL CORP.
K133039RESTORIS MULTICOMPARTMENTAL KNEE SYSTEMMAKO SURGICAL CORPORATION
K093513IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMCONFORMIS, INC.
K093056SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEMSMITH & NEPHEW, INC.
K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMAKO SURGICAL CORPORATION
K070849DEPUY GCK FEMORAL AND TIBIAL COMPONENTSDEPUY ORTHOPAEDICS, INC.
K061648DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)DEPUY ORTHOPAEDICS, INC.
K061569SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTSSMITH & NEPHEW, INC.
K053488CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEMCONFORMIS, INC.
K052917STRYKER COMPARTMENTAL KNEE SYSTEMHOWMEDICA OSTEONICS CORP
K052265SMITH & NEPHEW COMPETITOR DUO KNEE FEMORALSMITH & NEPHEW, INC.
K042896SMITH & NEPHEW HYBRID KNEE FEMORALSMITH & NEPHEW, INC.

Global Unique Device Identification Database

00850268007439Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
00850268007422Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
00850268007415Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
00850268007408Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
00850268007392Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
00850268007385Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
00850268007378Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
00850268007361Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
00848486020644PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00848486020279PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00848486020248PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00848486020224PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00848486020194PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00848486020132PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00848486020101PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Maude Adverse Events

MCK TIBIAL BASEPLATE-LM/RL-SZ 3MAKO SURGICAL CORP.2020-03-25
MCK FEMORAL-LM-RL-SZ 3MAKO SURGICAL CORP.2020-03-25
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MMMAKO SURGICAL CORP.2020-03-13
MCK TIBIAL BASEPLATE-RM/LL-SZ 4MAKO SURGICAL CORP.2020-03-11
MCK TIBIAL BASEPLATE-LM/RL-SZ 5MAKO SURGICAL CORP.2020-03-05
MCK TIBIAL BASEPLATE-RM/LL-SZ 6MAKO SURGICAL CORP.2020-03-05
MCK TIBIAL BASEPLATE-RM/LL-SZ 6MAKO SURGICAL CORP.2020-03-05
MCK TIBIAL BASEPLATE-LM/RL-SZ 5MAKO SURGICAL CORP.2020-03-04
MCK FEMORAL-LM-RL-SZ 5MAKO SURGICAL CORP.2020-03-04
IDUO G2CONFORMIS, INC.2020-02-26
MCK TIBIAL ONLAY INSERT-SZ 6-8MMMAKO SURGICAL CORP.2020-02-05
IDUO G2CONFORMIS, INC.2020-01-23
IDUO G2CONFORMIS, INC.2020-01-03
FEMORAL TEMPLATE STD LM/RL SIZE 1MAKO SURGICAL CORP.2019-12-23
DEUCE FEM OXZR SZ 4 LTSMITH & NEPHEW, INC.2019-11-29
TRI RM/LL TIB AUG SZ2 10MMSTRYKER ORTHOPAEDICS-MAHWAH2019-11-15
UNKNOWN SIZE 6 RIGHT TS FEMORAL COMPONENTSTRYKER ORTHOPAEDICS-MAHWAH2019-11-13
IDUO G2CONFORMIS, INC.2019-11-11
IDUO G2CONFORMIS, INC.2019-11-11
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MMMAKO SURGICAL CORP.2019-10-30
IMPACTOR-ONLAY INSERTMAKO SURGICAL CORP.2019-10-17
MCK PATELLOFEMORAL-R-SZ 3MAKO SURGICAL CORP.2019-10-14
UNKNOWN T-HANDLEMAKO SURGICAL CORP.2019-10-07
FEMORAL TRIAL STD RM/LL SIZE 5MAKO SURGICAL CORP.2019-10-07
IDUO G2CONFORMIS, INC.2019-09-24
ONLAY INSERT EXTRACTORMAKO SURGICAL CORP.2019-09-19
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MMMAKO SURGICAL CORP.2019-09-17
DEUCE FEM OXZR SZ 4 LTSMITH & NEPHEW, INC.2019-09-10
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MMMAKO SURGICAL CORP.2019-09-10
IDUO G2CONFORMIS, INC.2019-08-30
MCK TIBIAL BASEPLATE-RM/LL-SZ 6MAKO SURGICAL CORP.2019-08-29
IMPACTOR-ONLAY INSERTMAKO SURGICAL CORP.2019-08-27
FEMORAL TRIAL SLAPHAMMERMAKO SURGICAL CORP.2019-08-19
UNKNOWN HMRS CONSTRUCTSTRYKER ORTHOPAEDICS-MAHWAH2019-08-13
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MMMAKO SURGICAL CORP.2019-08-05
MCK TIBIAL BASEPLATE-LM/RL-SZ 5MAKO SURGICAL CORP.2019-07-29
UNKNOWN_JOINT REPLACEMENT_PRODUCTSTRYKER ORTHOPAEDICS-MAHWAH2019-07-26
UNKNOWN STRYKER KNEESTRYKER ORTHOPAEDICS-MAHWAH2019-07-23
ONLAY INSERT EXTRACTORMAKO SURGICAL CORP.2019-07-08
MCK PATELLOFEMORAL-L-SZ 3MAKO SURGICAL CORP.2019-06-19
MCK PATELLOFEMORAL-R-SZ 4MAKO SURGICAL CORP.2019-06-12
MCK TIBIAL BASEPLATE-RM/LL-SZ 7MAKO SURGICAL CORP.2019-06-11
CEMENT REMOVAL TOOLMAKO SURGICAL CORP.2019-05-31
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MMMAKO SURGICAL CORP.2019-05-17
MCK TIBIAL BASEPLATE-LM/RL-SZ 6MAKO SURGICAL CORP.2019-05-14
FEMORAL TRIAL SLAPHAMMERMAKO SURGICAL CORP.2019-05-07
HMRS DISTAL FEMUR RIGHT 12OMMSTRYKER ORTHOPAEDICS-MAHWAH2019-05-06
MCK TIBIAL ONLAY INSERT-SZ 5-8MMMAKO SURGICAL CORP.2019-05-01
TIBIAL INLAY IMPACTOR HEADMAKO SURGICAL CORP.2019-04-30
IMPACTOR-ONLAY INSERTMAKO SURGICAL CORP.2019-04-16

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