FDA.reportPublic FDA data

GII

Primary DI
00885556741245
Brand
GII
Company
Smith & Nephew, Inc.
Model
E0016380-15
Catalog number
E0016380-15
Device description
GII PS HIGH FLEX INSERT 7-8 11MM
Published
2019-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121443000JOURNEY II CR KNEE SYSTEMSmith & Nephew, Inc.2012-08-13JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556741245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556741245008855567412458855567412450885556741245

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trialA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556819784UNI-CP Compression Plate286310ND286310ND2023-10-26
00885556819791UNI-CP Compression Plate286312ND286312ND2023-10-26
00885556810613AETOS Shoulder SystemLNR-0990-200-423SLNR-0990-200-423S2023-02-13
00885556831892Salto Talaris Total Ankle ProsthesisLJU225TLJU225T2022-12-21
00885556835333Ti6 Internal Fixation SystemFS2040FS20402022-12-22
00885556839034Total Foot System 2283303528330352022-12-21
00885556839058Total Foot System 2283501028350102022-12-21
00885556839065Total Foot System 2283501228350122022-12-21
00885556839096Total Foot System 2283501828350182022-12-21
00885556839126Total Foot System 2283502428350242022-12-21
00885556839157Total Foot System 2283503028350302022-12-21
00885556839164Total Foot System 2283503528350352022-12-21
00885556839409Total Foot System 2284512028451202022-12-21
00885556841419XT Revision Ankle Replacement SystemLJV316TLJV316T2022-12-21
00885556865118Universal2 Total Wrist Implant System2645352645352023-01-19
00885556865231Universal2 Total Wrist Implant System2663012663012023-01-19
00885556865279Universal2 Total Wrist Implant System2664022664022023-01-19
00885556835647Ti6 Internal Fixation SystemTC2508TC25082022-12-22
00885556835654Ti6 Internal Fixation SystemTC2510TC25102022-12-22
00885556835760Ti6 Internal Fixation SystemTC3010TC30102022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811767028394FreedomMAXX ORTHOPEDICS, INC.JWH2026-09-21
00840333926413Freedom Metaphyseal ConeMAXX ORTHOPEDICS, INC.JWH2026-09-21
00840333926420Freedom Metaphyseal ConeMAXX ORTHOPEDICS, INC.JWH2026-09-21
00840333926437Freedom Metaphyseal ConeMAXX ORTHOPEDICS, INC.JWH2026-09-21
00840333926444Freedom Metaphyseal ConeMAXX ORTHOPEDICS, INC.JWH2026-09-21
00840333926451Freedom Metaphyseal ConeMAXX ORTHOPEDICS, INC.JWH2026-09-21
00840333926468Freedom Metaphyseal ConeMAXX ORTHOPEDICS, INC.JWH2026-09-21
00840333926475Freedom Metaphyseal ConeMAXX ORTHOPEDICS, INC.JWH2026-09-21
00840333926482Freedom Metaphyseal ConeMAXX ORTHOPEDICS, INC.JWH2026-09-21
00192629005419ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005426ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005433ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005440ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005457ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005464ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005488ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005495ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005501ADVANCEMicroport Orthopedics Inc.JWH2026-09-18
00192629005518ADVANCEMicroport Orthopedics Inc.JWH2026-09-18
00192629005549ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005556ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005563ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005570ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629082854EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18