# K181539: OSSDSIGN Cranioplug

- Pathway: 510(k) (Traditional)
- Applicant: Ossdsign AB
- Decided: Oct 12, 2018 after 123 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: 9 generations back to K873689 (1987). 50 ancestors in all.
1 later device descends 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)
- K140309: Cranioplug, Ossdsign AB (2014) Summary page 4.

## Most influential descendants
- K253447: Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (2026), 0 descendants of its own

## Indications for use
OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.

Source page: https://510kreport.com/device/K181539
Methodology: https://510kreport.com/methodology