FDA.report

KALIX II

Primary DI
10381780048152
Brand
KALIX II
Company
NEWDEAL
Model
141009ND
Catalog number
141009ND
Device description
The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780048152PrimaryGS10
M248141009ND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178004815210381780048152

GMDN Terms

TermDefinition
Subtalar implant, non-bioabsorbableA device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
536935331
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
M248119309ND1FOREFOOT SOLUTIONS™119309ND2017-05-26
M248119319ND1LARGE UNI-CLIP®119319ND2017-05-26
M248119321ND1LARGE UNI-CLIP®119321ND2017-05-26
M248239030ND1IPP-ON®239030ND2017-05-26
M248119510ND1I.CO.S®119510ND2017-05-26
M248119511ND1I.CO.S®119511ND2017-05-26
M248119532ND1I.CO.S®119532ND2017-05-26
M248119536ND1I.CO.S®119536ND2017-05-26
M248119562ND1I.CO.S®119562ND2017-05-26
M248119566ND1I.CO.S®119566ND2017-05-26
10381780045892IPP-ON230001SND230001SND2017-10-09
10381780045908IPP-ON230002SND230002SND2017-10-09
M248PANTAXLSET1PANTA XLPANTAXLSETPANTAXLSET2015-09-24
10381780125891PANTAREPANTASETREPANTASET2015-09-24
10381780064381B-BOPBBOPSETBBOPSET2017-10-09
M248119580ND1I.CO.S®119580ND2017-05-26
M248119590ND1I.CO.S®119590ND2017-05-26
M248139107ND1METIS®139107ND2017-05-26
M248529061ND1SURFIX®529061ND2017-06-06
10381780043317BASAL DORSAL PLATE116010SND116010SND2017-10-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810211040227Headed Screw Partially Threaded Short 3.0mm,30mm LengthPace Surgical, Inc.HWC2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529090Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529113Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529151Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529182Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529212Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529373Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529434Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529441Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529526Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531918Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531932Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531949Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531963Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531970Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531987Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532007Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532014Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532069Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532137Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532281Arthrex®ARTHREX, INC.HWC2026-03-16
04053613298315Guide Pin SmoothGebr. Brasseler GmbH & Co. KGHWC2026-03-11
00840124525474PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00840124525481PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10