# K023862: Norian XR Calcium Phosphate Bone Void Filler

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Dec 19, 2002 after 29 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K051951: Cerament Bone Void Filler (2005), 10 descendants of its own
- K073316: Cerament Bone Void Filler, Model A0210 (2008), 6 descendants of its own
- K201535: Cerament Bone Void Filler (2020), 3 descendants of its own
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own
- K071004: Osteocrete Bone Void Filler (2009), 2 descendants of its own

## Indications for use
Norian@XR Calcium Phosphate Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian@XR Calcium Phosphate Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs over a period of years and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K023862
Methodology: https://510kreport.com/methodology