# K190754: Orthoss (R)

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Jun 23, 2019 after 90 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: 3 generations back to K871773 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090401: Orthoss, Ed. Geistlich Soehne AG Fur Chemische Industrie (2010) Summary page 4.

## Indications for use
ORTHOSS® is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis). ORTHOSS® can be used with autograft as a bone graft extender in a posterolateral spine fusion. These osseous defects may be surgically created or be the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The device resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K190754
Methodology: https://510kreport.com/methodology