# K052812: Ossimend (TM) Bone Graft Material

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Jan 25, 2006 after 113 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). 21 ancestors in all.
40 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012751: Healos Bone Graft Material, Orquest, Inc. (2001) Summary page 1.
- K033679: Copsios Bone Void Filler (BVF), Centerpulse Spine-Tech, Inc. (2004) Summary page 1.
- K000122: Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6 Strips Per Box), Neucoll, Inc. (2001) Summary page 1.
- K032288: Vitoss Scaffold Foam Bone Graft Material, Orthovita, Inc. (2003) Summary page 1.
- K014289: Orthoss Resorbable Bone Void Filler, Geistlich-Pharma (2002) Summary page 1.
- K043034: Osteoguide Anorganic Bone Mineral Products, Collagen Matrix, Inc. (2005) Summary page 1.

## Most influential descendants
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own
- K181225: Altapore (2018), 6 descendants of its own
- K193075: Osteo3 ZP Putty (2020), 4 descendants of its own
- K192363: Altapore (2020), 4 descendants of its own

## Indications for use
OssiMend, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., extiemities, spine, and pelvis) 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.

Source page: https://510kreport.com/device/K052812
Methodology: https://510kreport.com/methodology