# K051603: Stryker Injectable Cement

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger Micro Implants
- Decided: Dec 30, 2005 after 198 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.
3 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043334: Bone Source Hac Rapid Setting Cement, Stryker Instruments (2005) Summary page 1.
- K041842: Norian SRS Fast Set Putty, Synthes (Usa) (2004) Summary page 1.
- K024336: Miig II Bone Graft Substitute, Wrightmedicaltechnologyinc (2003) Summary page 1.

## Most influential descendants
- K140309: Cranioplug (2014), 2 descendants of its own
- K181539: OSSDSIGN Cranioplug (2018), 1 descendant of its own
- K253447: Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (2026), 0 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, oraniofacial, 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.

Source page: https://510kreport.com/device/K051603
Methodology: https://510kreport.com/methodology