# K251556: Device 300423 Granules

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Jul 17, 2025 after 57 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: 8 generations back to K960978 (1996). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241802: Device 300397 Putty, Geistlich Pharma AG (2024) Summary page 5.

## Indications for use
Device 300423 Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Device 300423 Granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, ilium 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 and is replaced with bone during the healing process. Device 300423 Granules must be used with blood or autogenous bone marrow aspirate and autograft in posterolateral spine.

Source page: https://510kreport.com/device/K251556
Methodology: https://510kreport.com/methodology