FDA.reportPublic FDA data

K2™ Hemi Toe Implant System

Primary DI
M24820310041
Brand
K2™ Hemi Toe Implant System
Company
INTEGRA LIFESCIENCES CORPORATION
Model
2031004
Catalog number
2031004
Device description
K2™ Hemi Toe Implant System TOE PLATE
Published
2018-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWDPROSTHESIS, TOE, HEMI-, PHALANGEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWDProsthesis, Toe, Hemi-, PhalangealOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023770000K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)Kinetikos Medical, Inc.2002-12-12KWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780279471PrimaryGS10
M24820310041SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178027947110381780279471

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.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
963856096
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780272618Omni-Tract®11908119082018-02-23
20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810005668095TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668101TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668118TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668187TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963565TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963572TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00850044114962Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635037Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635198Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635204Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635211Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635228Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635235Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635242Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635259Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635266Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635273Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635280Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635297Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635303Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635310Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635327Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635334Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635341Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635358Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850005618102BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618119BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618126BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618133BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618140BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25