# K042305: Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901, Ossaplast Ortho, 3.0ML, Model# 221 903

- Pathway: 510(k) (Abbreviated)
- Applicant: Ossacur AG
- Decided: Oct 21, 2004 after 57 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 K014156 (2002). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014156: Cerasorb Ortho, Curasan AG (2002) Summary page 1.

## Most influential descendants
- K050416: Ossaplast Ortho (2005), 1 descendant of its own
- K051047: Colloss E Bone Void Filler (2006), 0 descendants of its own

## Indications for use
OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K042305
Methodology: https://510kreport.com/methodology