# K140309: Cranioplug

- Pathway: 510(k) (Traditional)
- Applicant: Ossdsign AB
- Decided: Oct 3, 2014 after 238 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K873689 (1987). 49 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120352: Stryker Quikflap Sterile Procedure Pack, Stryker (2012) Summary page 4.
- K051603: Stryker Injectable Cement, Stryker Leibinger Micro Implants (2005) Summary page 4.

## Most influential descendants
- 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
OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.

Source page: https://510kreport.com/device/K140309
Methodology: https://510kreport.com/methodology