# K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute

- Pathway: 510(k) (Special)
- Applicant: Orthovita, Inc.
- Decided: Nov 6, 2008 after 27 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: 6 generations back to K960978 (1996). 20 ancestors in all.
47 later devices descend from it; 11 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072184: Vitoss Bioactive Foam Bone Graft Substitute, Orthovita, Inc. (2007) Summary page 1.
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 1.
- K032288: Vitoss Scaffold Foam Bone Graft Material, Orthovita, Inc. (2003) Summary page 3.
- K032130: Vitoss-Filled Cartridge, Orthovita, Inc. (2003) Summary page 5.
- K032409: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita, Inc. (2003) Summary page 7.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 7.

## Most influential descendants
- K090855: Equivabone Osteoinductive Bone Graft Substitute (2009), 25 descendants of its own
- K091607: Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone (2009), 22 descendants of its own
- K093447: Carrigen (2010), 21 descendants of its own
- K103173: Vitoss BA Bimodal Bioactive Bone Graft Substitute (2011), 17 descendants of its own
- K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen (2010), 10 descendants of its own

## Indications for use
Vitoss Bone Graft Substitute 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 Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. Vitoss Bone Graft Substitute is intended for use as a bone void filter for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. Vitoss Bone Graft Substitute Filled Canister is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. The Canister provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Bone Graft Substitute and deliver the material to the orthopaedic surgical site. Vitoss Foam Bone Graft Substitute 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 Foam Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. Vitoss Bioactive Foam Bone Graft Substitute 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 Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. 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/K083033
Methodology: https://510kreport.com/methodology