# K234013: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg  OSTEOCRETE™

- Pathway: 510(k) (Traditional)
- Applicant: Bone Solutions, Inc.
- Decided: Feb 5, 2024 after 48 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: 26 generations back to K841189 (1984). 314 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 318 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232315: Catalyst Bone Void Filler, Ossdsign AB (2023) Summary page 6.
- K231528: Bonalive Orthopedics granules, Bonalive Biomaterials, Ltd. (2023) Summary page 6.

## Most influential descendants
- 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

## Indications for use
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process. Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine. When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process. Mg OSTEOCRETE™ must be used with morselized autograft bone in the posterolateral spine. When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Source page: https://510kreport.com/device/K234013
Methodology: https://510kreport.com/methodology