FDA.reportPublic FDA data

K2™ Hemi Toe Implant System

Primary DI
10381780065562
Brand
K2™ Hemi Toe Implant System
Company
Ascension Orthopedics, Inc.
Model
201030
Catalog number
201030
Device description
The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted into the medullary canal of the phalanx. It is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Published
2017-10-09
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
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
10381780065562PrimaryGS10
M2482010301SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178006556210381780065562

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.

Contacts#

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

Regulatory Flags#

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