FDA.reportPublic FDA data

Integra® MOVEMENT® Great Toe System

Primary DI
10381780119913
Brand
Integra® MOVEMENT® Great Toe System
Company
Ascension Orthopedics, Inc.
Model
MGT89030PPT
Catalog number
MGT89030PPT
Device description
The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
10381780119913PrimaryGS10
M268MGT89030PPT1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011991310381780119913

GMDN Terms#

Term, Definition table
TermDefinition
Partial metatarsophalangeal joint prosthesisA sterile 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 [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] and 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
942377524
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240310Cadence™102031932016-08-24
10381780245513BioMotion® Cannulated 1st MPJ Hemi SystemHM 3010HM 30102017-09-05
10381780245629Titan™IP0920055001IMP-0920-055-0012017-09-05
10381780245636Titan™IP0920064001IMP-0920-064-0012017-09-05
10381780245643Titan™IP0920079501IMP-0920-0795-012017-09-05
10381780245650Titan™IMP096006401IMP-0960-064-012017-09-05
10381780245667Titan™IMP096006601IMP-0960-066-012017-09-05
10381780245674Titan™IMP096007101IMP-0960-071-012017-09-05
10381780245681Ascension®IMP10000DIMP-100-00D2017-09-05
10381780245698Ascension®IMP10000PIMP-100-00P2017-09-05
10381780245704Integra®IMP20000DIMP-200-00D2017-09-05
10381780245711Integra®IMP20000PIMP-200-00P2017-09-05
10381780245728Integra®IMP30000IMP-300-002017-09-05
10381780245735Integra®IMP35000IMP-350-002017-09-05
10381780245759NuGrip® CMC Implant SystemIMP44200IMP-442-002017-09-05
10381780245766First Choice® DRUJ SystemIMP60000IMP-600-002017-09-05
10381780245780Movement®IMP-890-00MTIMP-890-00MT2017-09-05
10381780245797Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780245803Integra®IMP90001IMP-900-012017-09-05
10381780245988Integra®MAL092008501MAL-0920-085-012017-08-30

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