# K060763: Stryker Injectable Cement

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Sep 22, 2006 after 185 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- Recalls of this device: 1 (0 Class I)
- 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.
8 later devices descend from it; 5 cite it directly.
0 of 27 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 1.
- K043334: Bone Source Hac Rapid Setting Cement, Stryker Instruments (2005) Summary page 1.

## Most influential descendants
- K241027: Permatage Settable Bone Putty (2024), 2 descendants of its own
- K221933: MONTAGE Settable, Resorbable Bone Putty (2023), 1 descendant of its own
- K261265: Permatage XT Settable Bone Putty (2026), 0 descendants of its own
- K253732: Permatage Flowable, Settable Bone Paste (2026), 0 descendants of its own
- K253854: MONTAGE XT Cranial Cement (2026), 0 descendants of its own

## Recalls of this device
- Jul 30, 2013 · Class II · Z-2054-2013: Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of 

## 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. extremitiers-rariiotaiii, sgyiit,;.aid pcevis). 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 call 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. Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

Source page: https://510kreport.com/device/K060763
Methodology: https://510kreport.com/methodology