# K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita Co.
- Decided: Dec 14, 2000 after 357 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.
385 later devices descend from it; 26 cite it directly.
0 of 386 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) Pro Osteon 500R Resorbable Bone Void Filler: named in the summary without a submission number

## Most influential descendants
- K032268: MBCP (2003), 142 descendants of its own
- K030131: Ossatura BCP Bone Void Filler (2003), 133 descendants of its own
- K043005: Modification to MBCP (2005), 122 descendants of its own
- K040082: Pore-SI Bone Graft Substitute (2004), 113 descendants of its own
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute (2007), 111 descendants of its own

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

Source page: https://510kreport.com/device/K994337
Methodology: https://510kreport.com/methodology