# K090387: Kainos+

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Sep 28, 2009 after 223 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K960978 (1996). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020986: Mastergraft Resorbable Ceramic, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.
- K032268: MBCP, Biomatlante (2003) Summary page 1.
- K080511: Plexur-P, Osteotech, Inc. (2008) Summary page 1.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000). Our reading of the summary gave K094337, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Vitoss”. Summary page 1.
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 1.

## Indications for use
KAINOS®+ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. KAINOS®+ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, KAINOS®+ gradually resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K090387
Methodology: https://510kreport.com/methodology