# K143661: DirectInject

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Sep 2, 2015 after 253 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: 9 generations back to K873689 (1987). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060763: Stryker Injectable Cement, Stryker (2006) Summary page 4.
- K021440: Bonesource Hac, Stryker Instruments (2002) Summary page 4.

## Recalls of this device
- Apr 1, 2021 · Class II · Z-1436-2021: Inability for the user to inject the paste from the syringe into the target location.

## Indications for use
DirectInject is a self-setting, calcium phosphate cement intended to repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects not intrinsic to the stability of the bony structure. It is also intended for augmentation or restoration of bony contour in the craniofacial skeleton to include the cranial and zygomatic bones. DirectInject is intended to repair cranial defects with a surface area of 4 cm² or less. DirectInject is indicated for patients in whom skeletal growth is complete. It can be used in patients with surgically created bone defects.

Source page: https://510kreport.com/device/K143661
Methodology: https://510kreport.com/methodology