Identity
- Trade Name
- KAINOS+ FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- Bone graft substitute, granulate 2-3mm FDA UDI
- 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). FDA UDI
Identifiers
- Catalog Number
- K002NT FDA UDI
- Primary DI / UDI-DI
- 04047844023747 FDA UDI
- 510(k) Number
- K090387 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
Kainos+ by SIGNUS Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone matrix implant, synthetic, non-antimicrobial.
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft · Class II
- FIBERGRAFT BG Matrix — Prosidyan, Inc. · Class II
- MagnetOs — Kuros Biosciences B.V · Class II
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft · Class II
- NovoGro Putty — OSTEONOVUS, INC. · Class II
- PRO OSTEON 500 — Biomet Orthopedics, Inc. · Class II
- Syntricer — medArtis Medizinprodukte und Forschung Aktiengesellschaft · Class II
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft · Class II
Cleared under the same submission
K090387 also covers:
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
- KAINOS+ — SIGNUS Medizintechnik GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SIGNUS Medizintechnik GmbH
Sources (1)
- FDA UDI 272166b3-4cf8-47e4-b366-9301216a8213 38 fields · synced May 30, 2026