# K173572: DSM Biomedical Calcium Phosphate Cement with Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corporation Dba Dsm Biomedical
- Decided: May 9, 2018 after 170 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: 8 generations back to K873689 (1987). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060061: Stryker Injectable Cement, Stryker Corp. (2006) Summary page 4.

## Indications for use
DSM Biomedical Calcium Phosphate Cement with Microspheres is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement with Microspheres is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement with Microspheres cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement with Microsheres resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K173572
Methodology: https://510kreport.com/methodology