LGE

Product Code: LGE

Products Classified as LGE

4592

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing

Knee Joint Femorotibial Metal/polymer Semi-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4592

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing

Knee Joint Femorotibial Metal/polymer Semi-constrained Cemented Prosthesis.

FDA Consensus Standards

• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [34059]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [38231]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [37410]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [37411]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [33508]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [32210]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [32380]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [33509]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [33949]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [32381]: 21 CFR §888.3530 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing [34076]: 21 CFR §888.3530 🔎

Pre-market Notifications for LGE

K992346	KINEMATIC II ROTATING HINGE KNEE	HOWMEDICA OSTEONICS CORP.
K811630	KINEMATIC ROTATING HINGE TOTAL KNEE PR.	HOWMEDICA CORP.

Global Unique Device Identification Database

• 07613327048254: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING
• 07613327046656: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING

Maude Adverse Events

TIBIAL COMP KIN HINGE KNEE	STRYKER ORTHOPAEDICS-MAHWAH	2018-10-08
8MM PT2 ALLPOLY TIB KRH XXSML	STRYKER ORTHOPAEDICS-MAHWAH	2018-07-27
TIBIAL COMP KIN HINGE KNEE	STRYKER ORTHOPAEDICS-MAHWAH	2015-11-25
TIB/BEARING 21MM THICK FOR	STRYKER ORTHOPAEDICS-MAHWAH	2015-02-04
TIBIAL COMP KIN HINGE KNEE	STRYKER ORTHOPAEDICS-MAHWAH	2014-11-14
TIBIAL COMP KIN HINGE KNEE	STRYKER ORTHOPAEDICS-MAHWAH	2014-11-13
KINMTC ROT HINGE SHRT TIB BEAR	STRYKER ORTHOPAEDICS-MAHWAH	2014-09-11
TIBIAL COMP KIN HINGE KNEE	STRYKER ORTHOPAEDICS-MAHWAH	2014-07-31
TIBIAL COMP KIN HINGE KNEE	STRYKER ORTHOPAEDICS-MAHWAH	2014-01-07
TIB BEARING COMP ROT/HIN KNEE	STRYKER ORTHOPAEDICS LIMERICK	2012-03-28
TIB BEARING COMP ROT/HIN KNEE	STRYKER ORTHOPAEDICS LIMERICK	2012-03-21
SHORT TIBIA BEARING COMPONENT	STRYKER ORTHOPAEDICS LIMERICK	2011-03-02
KINEMATIC I/II	STRYKER ORTHOPAEDICS LIMERICK	2010-10-25
KINEMATIC II	STRYKER ORTHOPAEDICS LIMERICK	2010-10-25
KIIIMPLANT	STRYKER ORTHOPAEDICS LIMERICK	2010-10-25
KINEMATIC II	STRYKER ORTHOPAEDICS LIMERICK	2010-10-25
KINEMATIC II	STRYKER ORTHOPAEDICS LIMERICK	2010-10-25
KINEMATIC	STRYKER ORTHOPAEDICS LIMERICK	2010-10-21
TIB BEARING COMP ROT/HIN KNEE	STRYKER ORTHOPAEDICS LIMERICK	2010-10-06
TEST	FINAL TESTING	2007-04-20
TEST	TEST	2007-04-20
TIB BEARING COMP ROT/HIN KNEE	STRYKER ORTHOPAEDICS LIMERICK	2004-11-19
KINEMATIC ROTATING HINGE TIBIAL COMPONENT	STRYKER ORTHOPAEDICS	2004-04-23
FEM COMP ROT/HINGED KNEE RIGHT	STRYKER HOWMEDICA OSTEONICS	2004-01-07
STANDARD BUSHING, MRS	HOWMEDICA OSTEONICS CORP.	2003-03-20
KINMTC ROTAT KN TIBL W/O B/PLG	HOWMEDICA INC.	1998-03-06