# K061022: Bio 1-Kit Biosorb Filled Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Science For Biomaterials
- Decided: May 24, 2006 after 41 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: 2 generations back to K994337 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032130: Vitoss-Filled Cartridge, Orthovita, Inc. (2003) Summary page 1.
- K021963: Biosorb Resorbable Void Filler, Sciences ET Bio Materiaux (Sbm) (2003) Summary page 1.

## Indications for use
BIOSORB ® Resorbable Void Filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB ® Resorbable Void Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans. The BIO 1-KIT ®BIOSORB 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 the BIOSORB * Resorbable Void Filler and deliver the material to the orthopedic surgical site.

Source page: https://510kreport.com/device/K061022
Methodology: https://510kreport.com/methodology