# K032288: Vitoss Scaffold Foam Bone Graft Material

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Dec 19, 2003 after 148 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
No predicates in its family tree.
123 later devices descend from it; 17 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vitoss Scaffold Synthetic Cancellous Bone Void Filler: named in the summary without a submission number
- (no number) Healos Bone Graft Material: named in the summary without a submission number

## Most influential descendants
- K051386: Mastergraft Putty Bone Void Filler (2005), 59 descendants of its own
- K072184: Vitoss Bioactive Foam Bone Graft Substitute (2007), 51 descendants of its own
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute (2008), 50 descendants of its own
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute (2008), 47 descendants of its own
- K071813: Mastergraft Putty (2007), 47 descendants of its own

## Indications for use
Vitoss Scaffold Foam Bone Graft Material is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K032288
Methodology: https://510kreport.com/methodology