# K021963: Biosorb Resorbable Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Sciences ET Bio Materiaux (Sbm)
- Decided: Jan 28, 2003 after 228 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994337 (2000). 1 ancestor in all.
21 later devices descend from it; 8 cite it directly.
0 of 23 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.

## Cited in the summary but kept off the family tree
- K098017: PRO OSTEON 500R Resorbable Bone void filler. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K050407: Ligafix Resorbable Interference Screw, Models 30 and 60 (2005), 7 descendants of its own
- K061262: Ligafix Interference Screw (2006), 6 descendants of its own
- K041421: Name Bone Void Filler (2004), 4 descendants of its own
- K070507: Modification to: Ligafix Interference Screw (2007), 3 descendants of its own
- K051722: Tricos T (2005), 3 descendants of its own

## Recalls of this device
- Apr 7, 2025 · Class II · Z-1718-2025: Vials of implant bone granules may contain less product then specified on labeling.

## 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.

Source page: https://510kreport.com/device/K021963
Methodology: https://510kreport.com/methodology