# K213777: Stryker Resorbable Fixation System

- Pathway: 510(k) (Special)
- Applicant: Stryker Leibinger Micro Implants
- Decided: Feb 4, 2022 after 63 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: 6 generations back to K904436 (1990). 27 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113109: Stryker Resorbable Fixation System, Stryker (2011) Summary page 5.

## Most influential descendants
- K231208: Stryker Resorbable Fixation System (2023), 0 descendants of its own
- K230733: Stryker Resorbable Fixation System (2023), 0 descendants of its own

## Indications for use
Dental: The Delta Resorbable Fixation System is intended for use in the fixation of bones of the maxillofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients. Neuro: The Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients.

Source page: https://510kreport.com/device/K213777
Methodology: https://510kreport.com/methodology