# K002362: Synthes Calcium Sulfate Bone Void Filler Pellets (Synthes Pellets)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 1, 2000 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Wright Medical Technology’s OsteoSet® Pellets: named in the summary without a submission number

## Indications for use
Synthes Calcium Sulfate Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Pellets are to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the Pellets are biodegradable and biocompatible, they may be used at an infected site.

Source page: https://510kreport.com/device/K002362
Methodology: https://510kreport.com/methodology