# K062260: Osteoboost-Bma

- Pathway: 510(k) (Traditional)
- Applicant: Orthos Limited
- Decided: Oct 26, 2006 after 83 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Orthos-BMATM kit is intended for use by suitable trained surgical personnel only. The Orthos-BMATM kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects which can occur as a result of trauma or in skeletal defects created surgically.

Source page: https://510kreport.com/device/K062260
Methodology: https://510kreport.com/methodology