# K242782: GlassBone Granules

- Pathway: 510(k) (Traditional)
- Applicant: Noraker
- Decided: Dec 23, 2024 after 98 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: 6 generations back to K960978 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231528: Bonalive Orthopedics granules, Bonalive Biomaterials, Ltd. (2023) Summary page 5.

## Indications for use
GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients = 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K242782
Methodology: https://510kreport.com/methodology