# K042340: Kasios TCP

- Pathway: 510(k) (Traditional)
- Applicant: Kasios Biomaterials
- Decided: Nov 24, 2004 after 86 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K191670: CureOs TCP (2020), 0 descendants of its own
- K111018: Polyfuse - Neurobone (2012), 0 descendants of its own
- K062496: Osteopore TCP (2006), 0 descendants of its own

## Recalls of this device
- Dec 5, 2016 · Class II · Z-1019-2017: OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum 

## Indications for use
Kasios TCP is indicated only for filling bone voids or defects that are not intrinsic to the stability of the bony structure. Kasios TCP is to be gently packed into bony voids or gaps of the skeletal system (such as the extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Kasios TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K042340
Methodology: https://510kreport.com/methodology