# K161447: HydroSet XT

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Oct 6, 2016 after 134 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K013966 (2002). 44 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 55 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.
- K141245: Etex Mixing and Delivery System, Etex Corporation (2014) Summary page 4.

## Most influential descendants
- K173008: SCS 17-01 (2017), 4 descendants of its own
- K222063: MONTAGE Settable, Resorbable Bone Putty (2023), 3 descendants of its own
- K190956: SCS 17-01 (2020), 3 descendants of its own
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own
- K233566: Montage-XT Settable, Resorbable Bone Putty (2024), 1 descendant of its own

## Recalls of this device
- Nov 15, 2018 · Class II · Z-0678-2019: Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19
- Nov 15, 2018 · Class II · Z-0677-2019: Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19

## Indications for use
The Hydroset XT Mixing and Delivery System is intended to be used for the delivery of Hydroset XT to an orthopedic surgical site. HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system(i.e. extremities, craniofacial, posterolateral spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet XT is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. HydroSet XT 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 temporarysupport medium and is not intended to provide structural support during the healing process.

Source page: https://510kreport.com/device/K161447
Methodology: https://510kreport.com/methodology