# K232315: Catalyst Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Ossdsign AB
- Decided: Sep 15, 2023 after 44 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: 25 generations back to K841189 (1984). 309 ancestors in all.
7 later devices descend from it; 4 cite it directly.
1 of 317 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 4.

## Most influential descendants
- K234013: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg  OSTEOCRETE™ (2024), 3 descendants of its own
- K242372: Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (2024), 2 descendants of its own
- K251522: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (2025), 1 descendant of its own
- K262230: Mg OSTEOREVIVE™;Mg OSTEOCRETE™ (2026), 0 descendants of its own
- K241564: Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (2024), 0 descendants of its own

## Indications for use
Catalyst Bone Void Filler is indicated for filling bone voids or defects of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, extremities, and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or as a result of traumatic injury to the bone. Catalyst Bone Void Filler is a bone graft putty that is resorbed and replaced with bone during the healing process. Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. When used in intervertebral body fusion procedures, Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Source page: https://510kreport.com/device/K232315
Methodology: https://510kreport.com/methodology