Kainos+
510(k) K090387
Kainos+ is a Class II device made by SIGNUS Medizintechnik GmbH, cleared under FDA 510(k) K090387 on 28 Sep 2009, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090387 | Date28 Sep 2009 | StatusActive |
Official records
- FDA 510(k) database K090387
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQV
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K090387
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| KAINOS+ Bone graft substitute, granulate 2-3mm | K002NT / Bone graft substitute, granulate 2-3mm | 04047844023747 | — | On the market |
| KAINOS+ Bone graft substitute, granules 1-2mm | KS03NT / Bone graft substitute, granules 1-2mm | 04047844005996 | — | On the market |
| KAINOS+ Bone graft substitute, granules 1-2mm | KS06NT / Bone graft substitute, granules 1-2mm | 04047844006009 | — | On the market |
| KAINOS+ Bone graft substitute, granules 2-3mm | K001NT / Bone graft substitute, granules 2-3mm | 04047844005668 | — | On the market |
| KAINOS+ Bone graft substitute, granules 2-3mm | K003NT / Bone graft substitute, granules 2-3mm | 04047844005675 | — | On the market |
| KAINOS+ Bone graft substitute, granules 2-3mm | K004NT / Bone graft substitute, granules 2-3mm | 04047844005682 | — | On the market |
| KAINOS+ Bone graft substitute, granules 2-3mm | K005NT / Bone graft substitute, granules 2-3mm | 04047844005699 | — | On the market |
| KAINOS+ Bone graft substitute, granules 2-3mm | K006NT / Bone graft substitute, granules 2-3mm | 04047844005705 | — | On the market |
| KAINOS+ Bone graft substitute, insert for NUBIC | KNB041314 / Bone graft substitute, insert for NUBIC | 04047844005712 | — | On the market |
| KAINOS+ Bone graft substitute, insert for NUBIC | KNB051314 / Bone graft substitute, insert for NUBIC | 04047844005729 | — | On the market |
| KAINOS+ Bone graft substitute, insert for NUBIC | KNB061314 / Bone graft substitute, insert for NUBIC | 04047844005736 | — | On the market |
| KAINOS+ Bone graft substitute, insert for NUBIC | KNB071314 / Bone graft substitute, insert for NUBIC | 04047844005743 | — | On the market |
| KAINOS+ Bone graft substitute, insert for NUBIC | KNB081314 / Bone graft substitute, insert for NUBIC | 04047844005750 | — | On the market |
Similar devices
Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).
- PRO-DENSE BONE VOID FILLER by Wrightmedicaltechnologyinc
- EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE by Etex Corp.
- INQU by Isto Technologies, Inc.
- MagnetOs granules by Kuros Biosciences B.V
- OsteoFlo HydroFiber by SURGENTEC LLC
- BIOSET XCH by Regeneration Technologies, Inc.
- DBX DEMINERALIZED BONE MATRIX PUTTY by Musculoskeletal Transplant Foundation
- JAX by Smith & Nephew, Inc.
- MASTERGRAFT STRIP by MEDTRONIC SOFAMOR DANEK, INC.
- Cerasorb Ortho Foam by curasan AG