FDA.reportPublic FDA data

Toe MotionTM

Primary DI
M5289P15PB01A0
Brand
Toe MotionTM
Company
ARTHROSURFACE INCORPORATED
Model
9P15-PB01-A
Catalog number
9P15-PB01-A
Device description
Modular Insert, 2.5mm Offset -01 (3.6mm thick)
Published
2015-09-15
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
K132496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132496000ARTHROSURFACE TOEMOTIONArthrosurface, Inc.2014-02-26LZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5289P15PB01A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total metatarsophalangeal joint prosthesis, modularAn implantable substitute for the metatarsophalangeal (MTP) joint of the foot (toe) intended to repair both articulating surfaces with matching metatarsal and phalangeal components, typically to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] and polymer materials and implantation may be performed with or without bone cement. Disposable instruments associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-520-3003contact@arthrosurface.com

Regulatory Flags#

DUNS number
144666109
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M5288RB42310A0RevoMotion 8RB4-2310-A2026-05-21
M5288RG032ECA0RevoMotion 8RG0-32EC-A2026-05-21
M5288RG03600A0RevoMotion 8RG0-3600-A2026-05-21
M5288RG036ECA0RevoMotion 8RG0-36EC-A2026-05-21
M5288RG04000A0RevoMotion 8RG0-4000-A2026-05-21
M5288RG040ECA0RevoMotion 8RG0-40EC-A2026-05-21
M5288RG23200A0RevoMotion 8RG2-3200-A2026-05-21
M5288RG232ECA0RevoMotion 8RG2-32EC-A2026-05-21
M5288RG23600A0RevoMotion 8RG2-3600-A2026-05-21
M5288RG236ECA0RevoMotion 8RG2-36EC-A2026-05-21
M5288RG24000A0RevoMotion 8RG2-4000-A2026-05-21
M5288RG240ECA0RevoMotion 8RG2-40EC-A2026-05-21
M5288RG43200A0RevoMotion 3RG4-3200-A2026-05-21
M5288RG43600A0RevoMotion 8RG4-3600-A2026-05-21
M5288RG44000A0RevoMotion 8RG4-4000-A2026-05-21
M5288RM20600A0RevoMotion 8RM2-0600-A2026-05-21
M5288RM20800A0RevoMotion 8RM2-0800-A2026-05-21
M5288RM21000A0RevoMotion 8RM2-1000-A2026-05-21
M5288RM21200A0RevoMotion 8RM2-1200-A2026-05-21
M5288RM21400A0RevoMotion 8RM2-1400-A2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556828229Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-22
00885556828250Movement 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