# K191670: CureOs TCP

- Pathway: 510(k) (Traditional)
- Applicant: Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic
- Decided: Aug 4, 2020 after 410 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: 1 generation back to K042340 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042340: Kasios TCP, Kasios Biomaterials (2004) Summary page 4.

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

Source page: https://510kreport.com/device/K191670
Methodology: https://510kreport.com/methodology