# K060061: Stryker Injectable Cement

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Mar 1, 2006 after 51 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: 7 generations back to K873689 (1987). 17 ancestors in all.
30 later devices descend from it; 7 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024336: Miig II Bone Graft Substitute, Wrightmedicaltechnologyinc (2003) Summary page 2.
- K043334: Bone Source Hac Rapid Setting Cement, Stryker Instruments (2005) Summary page 2.
- K042516: Otomimix, Walter Lorenz Surgical, Inc. (2004) Summary page 2.

## Cited in the summary but kept off the family tree
- K051603: Stryker Injectable Cement, Stryker Leibinger Micro Implants (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K161447: HydroSet XT (2016), 10 descendants of its own
- K060763: Stryker Injectable Cement (2006), 8 descendants of its own
- 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

## Indications for use
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Stryker® Injectable Cement 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.

Source page: https://510kreport.com/device/K060061
Methodology: https://510kreport.com/methodology