# K241802: Device 300397 Putty

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Nov 8, 2024 after 140 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.
1 later device descends from it; 1 cites it directly.
0 of 21 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.

## Most influential descendants
- K251556: Device 300423 Granules (2025), 0 descendants of its own

## Indications for use
Device 300397 Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Device 300397 Putty 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 300397 Putty must be used with blood or autogenous bone marrow aspirate and autograft in posterolateral spine.

Source page: https://510kreport.com/device/K241802
Methodology: https://510kreport.com/methodology