# K230733: Stryker Resorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Aug 5, 2023 after 142 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: 7 generations back to K904436 (1990). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213777: Stryker Resorbable Fixation System, Stryker Leibinger Micro Implants (2022) Summary page 3.

## Indications for use
The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the maxillofacial and midfacial skeleton affected by trauma or for reconstruction, and can be used in pediatric patients older than 29 days and up to two (2) years of age (infants). The self-tapping screws and low profile emergency screws are designed to be compatible with the components (plates, meshes) of the Delta Resorbable Fixation System K213777.

Source page: https://510kreport.com/device/K230733
Methodology: https://510kreport.com/methodology