# K090401: Orthoss

- Pathway: 510(k) (Traditional)
- Applicant: Ed. Geistlich Soehne AG Fur Chemische Industrie
- Decided: Jan 8, 2010 after 325 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: 2 generations back to K871773 (1987). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014289: Orthoss Resorbable Bone Void Filler, Geistlich-Pharma (2002)
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004)

## Most influential descendants
- K171629: ABCcolla Bone Graft (2018), 1 descendant of its own
- K212156: ABCcolla Bone Matrix (2021), 0 descendants of its own
- K190754: Orthoss (R) (2019), 0 descendants of its own

## Indications for use
ORTHOSS® Resorbable Bone Void Filler is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS® is indicated only for use in bone voids or gaps 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. ORTHOSS® Resorbable Bone Void Filler is intended to be used in the spine only for posterolateral fusion.

Source page: https://510kreport.com/device/K090401
Methodology: https://510kreport.com/methodology