FDA.reportPublic FDA data

TOTAL TOE SYSTEM

Primary DI
00880304216907
Brand
TOTAL TOE SYSTEM
Company
Biomet Orthopedics, LLC
Model
117106
Catalog number
117106
Published
2018-12-19
Public version status
Update
Distribution status
Not 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
K920446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920446000TOTAL TOE SYSTEMBiomet, Inc.1993-03-22LZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304216907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304216907008803042169078803042169070880304216907

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)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24
00888480584711PRO OSTEON 500R5RB0405RB0402015-10-24

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
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