# K260364: Device 300419 Strip

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Jun 2, 2026 after 118 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: 7 generations back to K960978 (1996). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071813: Mastergraft Putty, Medtronic Sofamor Danek (2007) Summary page 5.

## Indications for use
Device 300419 Strip is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Device 300419 Strip 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 300419 Strip must be used with blood or autologous bone marrow aspirate and autograft in posterolateral spine.

Source page: https://510kreport.com/device/K260364
Methodology: https://510kreport.com/methodology