# K212991: Osteorevive

- Pathway: 510(k) (Traditional)
- Applicant: Bone Solutions, Inc.
- Decided: Jan 21, 2022 after 123 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: 9 generations back to K960978 (1996). 68 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071004: Osteocrete Bone Void Filler, Bone Solutions, Inc. (2009) Summary page 5.
- K140375: Mastergraft Putty, Mastergraft Strip, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K173362: DSM Biomedical Calcium Phosphate Cement, Kensey Nash Corporation Dba Dsm Biomedical (2018) Summary page 5.

## Most influential descendants
- K221256: Mg OSTEOINJECT (2022), 0 descendants of its own

## Indications for use
OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. 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. OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation. OSTEOREVIVE™ is resorbed and replaced with bone during the healing process. OSTEOREVIVE™ must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Source page: https://510kreport.com/device/K212991
Methodology: https://510kreport.com/methodology