# K252797: JAZBI™ Resorbable Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Sdip Innovations Pty, Ltd.
- Decided: May 26, 2026 after 265 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 K043045 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043045: Synthes (Usa) Chronos, Synthes (Usa) (2005) Summary page 5.

## Indications for use
JAZBI™ Resorbable Bone Void Filler is indicated for use in bony voids or defects that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors, are surgically created or the result of traumatic injury to the bone. JAZBI™ Resorbable Bone Void Filler is intended to be gently packed or placed into bony voids or defects of the extremities and pelvis. Following placement into the bony void, JAZBI™ Resorbable Bone Void Filler resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K252797
Methodology: https://510kreport.com/methodology