# K062496: Osteopore TCP

- Pathway: 510(k) (Traditional)
- Applicant: Spinecraft, Inc.
- Decided: Oct 19, 2006 after 55 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 1.

## Indications for use
OsteoPore TCP is indicated only for filling bone voids or defects of the skeletal system (such as the extremities, spine and the 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. OsteoPore TCP should be gently packed into the defect/void without under-filling or over-filling. OsteoPore TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K062496
Methodology: https://510kreport.com/methodology