# K993061: Stryker Leibinger Resorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Nov 19, 1999 after 67 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- 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: 4 generations back to K904436 (1990). 24 ancestors in all.
79 later devices descend from it; 3 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982531: Howmedica Leibinger Resorbable Fixation System, Howmedica Corp. (1998) Summary page 1.
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 1.
- K972913: Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces (1998) Summary page 1.
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System, Bionx Implants, Inc. (1998) Summary page 1.

## Most influential descendants
- K011590: Resorb-X Resorbable Plating System (2002), 73 descendants of its own
- K060177: KLS Martin Rigid Fixation  - Sterile (2006), 65 descendants of its own
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile (2007), 61 descendants of its own
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own
- K202889: Able Medical Devices Valkyrie Thoracic Fixation System (2021), 39 descendants of its own

## Indications for use
The Stryker Leibinger 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/K993061
Methodology: https://510kreport.com/methodology