# K051047: Colloss E Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Ossacur AG
- Decided: Mar 8, 2006 after 317 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: 5 generations back to K960978 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042305: Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901, Ossaplast Ortho, 3.0ML, Model# 221 903, Ossacur AG (2004) Summary page 1.
- K050416: Ossaplast Ortho, Ossacur AG (2005) Summary page 1.
- K012751: Healos Bone Graft Material, Orquest, Inc. (2001)
- K043308: Modification to: Healos Bone Graft Material, Depuy Spine, Inc. (2005) Summary page 1.
- K043420: Osteofil, Optefil, Regenafil, Rti Allograft Paste, Regeneration Technologies, Inc. (2005) Summary page 1.
- K043421: Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip IC, Regeneration Technologies, Inc. (2005) Summary page 1.
- K031399: Intergro DBM, Interpore Cross Intl. (2005) Summary page 1.

## Indications for use
COLLOSS E 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. COLLOSS E is resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K051047
Methodology: https://510kreport.com/methodology