# K062436: Sis Sinus Implant Stabilizer

- Pathway: 510(k) (Traditional)
- Applicant: Mondeal Medical Systems GmbH
- Decided: Jul 30, 2007 after 343 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894844 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.
- K951392: Miniboneplate System, Ace Surgical Supply Co., Inc. (1995) Summary page 1.
- K951688: Micro Titanium Plate System, Medicon EG (1995) Summary page 1.
- K042345: Lin/Liou Orthodontic Mini Anchor System (Lomas), Mondeal Medical Systems GmbH (2005) Summary page 1.
- K050257: Lin/Liou Orthodontic Mini Anchor System (Lomas) (Sterile), Mondeal Medical Systems GmbH (2005) Summary page 1.

## Indications for use
The SIS Sinus Implant Stabilizer is intended to provide a fixed anchorage point to stabilize dental implants in the sinus region, enabling sinus augmentation and implantation to be carried out in one session.

Source page: https://510kreport.com/device/K062436
Methodology: https://510kreport.com/methodology