FDA.reportPublic FDA data

Movement Great Toe System

Primary DI
00885556828250
Brand
Movement Great Toe System
Company
Smith & Nephew, Inc.
Model
MGT-890-20PPT
Catalog number
MGT-890-20PPT
Device description
MGT MOVEMENT PROX. PHAL. TOTAL SZ. 20
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZJPROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-ConstrainedUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102549000THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYAscension Orthopedics, Inc.2010-12-21LZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556828250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556828250008855568282508855568282500885556828250

GMDN Terms#

Term, Definition table
TermDefinition
Partial metatarsophalangeal joint prosthesisAn implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal or a metal/polymer combination, and may contain hyaluronic acid; implantation may be performed with or without bone cement. The device is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556833933Salto Talaris Total Ankle ProsthesisMJU952TMJU952T2022-12-22
00885556833940Salto Talaris Total Ankle ProsthesisMJU953TMJU953T2022-12-22
00885556833957Salto Talaris Total Ankle ProsthesisMJV219TMJV219T2022-12-22
00885556833964Salto Talaris Total Ankle ProsthesisMJV220TMJV220T2022-12-22
00885556833971Salto Talaris Total Ankle ProsthesisMJV221TMJV221T2022-12-22
00885556833988Salto Talaris Total Ankle ProsthesisMJV229TMJV229T2022-12-22
00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
00885556834251Silicone Toe SystemCGT-305TCGT-305T2022-12-22
00885556834299Silicone Toe SystemCGT-505TCGT-505T2022-12-22
00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
00885556835203Surgical InstrumentsFS-1006FS-10062022-12-22
00885556836187Ti6 Internal Fixation SystemTH3018TH30182022-12-22
00885556837856Total Foot System 2220425022042502022-12-22
00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
00885556841785XT Revision Ankle Replacement SystemMJV223TMJV223T2022-12-21
00885556854921Freedom Wrist Arthroplasty System3480473480472022-12-22
00885556856680Surgical InstrumentsEXT-200-00EXT-200-002022-12-22
00885556860168Titan Modular Shoulder System 2.5DRL-0923-047-001DRL-0923-047-0012022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556828229Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-22
00885556828281Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-22
00885556828311Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-22
00885556828410Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-21
00885556828441Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-21
00885556828472Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-21
00885556828502Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-21
00880304216860TOTAL TOE SYSTEMBiomet Orthopedics, LLCLZJ2018-12-19
00880304216907TOTAL TOE SYSTEMBiomet Orthopedics, LLCLZJ2018-12-19
00880304216914TOTAL TOE SYSTEMBiomet Orthopedics, LLCLZJ2018-12-19
00880304217003TOTAL TOE SYSTEMBiomet Orthopedics, LLCLZJ2018-12-19
10381780065395KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
10381780065401KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
10381780065418KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
10381780065425KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
10381780065432KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
10381780065449KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
10381780065456KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
10381780065463KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
10381780065470KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
10381780065487KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
M2480120031KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
M2480120101KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
M2480120021KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120041KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120051KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120061KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120071KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120121KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120141KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09