# K032130: Vitoss-Filled Cartridge

- Pathway: 510(k) (Special)
- Applicant: Orthovita, Inc.
- Decided: Nov 5, 2003 after 117 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: 1 generation back to K994337 (2000). 2 ancestors in all.
50 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.
- K030208: Imbibe II Syringe, Orthovita, Inc. (2003) Summary page 1.

## Most influential descendants
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute (2008), 47 descendants of its own
- 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

## Indications for use
VITOSS@Scaffold Synthetic Cancellous Bone Void Filler 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 is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS 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 packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process. The VITOSS-Filled Cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This Cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold@and deliver the material to the orthopaedic surgical site.

Source page: https://510kreport.com/device/K032130
Methodology: https://510kreport.com/methodology