# K113109: Stryker Resorbable Fixation System

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Dec 23, 2011 after 64 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904436 (1990). 26 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K993061: Stryker Leibinger Resorbable Fixation System, Stryker Instruments (1999) Summary page 1.
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 1.
- K983528: Micro Dynamic Mesh, Howmedica Corp. (1998) Summary page 1.

## Most influential descendants
- K213777: Stryker Resorbable Fixation System (2022), 2 descendants of its own
- 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
The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.

Source page: https://510kreport.com/device/K113109
Methodology: https://510kreport.com/methodology