# K051695: Marrow Plus (M+)

- Pathway: 510(k) (Traditional)
- Applicant: Berkeley Advanced Biomaterials, Inc.
- Decided: Jul 19, 2005 after 26 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063346: Pro Osteon 500R (2007), 0 descendants of its own

## Indications for use
Marrow Plus (M+TM) is intended for use as a system for the aspiration of bone marrow, either autologous blood, plasma or other blood components. Prior to use, the syringe is pre-filled or filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This system provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site. M+ may be pre-filled with synthetic bone substitute (Bi-Ostetic, Cem-Ostetic, Tri-Ostetic, BioPlus, GenerOs) shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks may be pressed into the void or into the surgical site by hand. The granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone ingrowth occurs.

Source page: https://510kreport.com/device/K051695
Methodology: https://510kreport.com/methodology