KAINOS+

Primary DI
04047844005668
Brand
KAINOS+
Company
SIGNUS Medizintechnik GmbH
Model
Bone graft substitute, granules 2-3mm
Catalog number
K001NT
Device description
KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). KAINOS+ is available in various shapes and sizes. KAINOS+ may be used with physiolo-gical saline, patient’s own serum, whole blood, or bone marrow aspirate (BMA).
Published
2015-09-24
Public version status
Update
Distribution status
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
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090387000KAINOS+Signus Medizintechnik GmbH2009-09-28MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844005668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844005668040478440056684047844005668

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49602391660info@signus.com

Regulatory Flags#

DUNS number
344203948
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
04047844129241DIPLOMATThreaded awl cannulated, obturatorAC00882026-05-20
04047844129258DIPLOMATThreaded awl cannulated, obturatorAC00892026-05-20
04047844102596COSYCross connectorCA0155-38048/S2023-03-21
04047844102602COSYCross connectorCA0155-44052/S2023-03-21
04047844098479COSYRetaining nut tulips cross connectorCA0160-002002023-03-15
04047844127063COSYTray, lidCB03AY-LID-12026-04-22
04047844098707COSYOcciput plateCA0005-320562023-03-15
04047844116432COSYObturatorwireCB0101-32023-03-15
04047844116449COSYGuide wire, round/roundCB01442023-03-15
04047844129272INSTRUMENTTray, instrumentsP009AY2026-02-11
04047844129289INSTRUMENTTray, insert, instrumentsP009AZ2026-02-11
04047844129296COSYTray, implantsCA01AY2026-02-11
04047844129302COSYTray, insert, implantsCA01AZ2026-02-11
04047844129319COSYTray, implantsCA02AY2026-02-11
04047844129326COSYRack, screwsCA1235AZ2026-02-11
04047844129333COSYRack, screwsCA1240AZ2026-02-11
04047844129340COSYRack, screwsCA1245AZ2026-02-11
04047844129357COSYRack, shank screwsCA1735AZ2026-02-11
04047844129364COSYRack, shank screwsCA1740AZ2026-02-11
04047844129371COSYRack, screws angledCA3235AZ2026-02-11

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Primary DI, Brand, Company table
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