# K211695: Valkyrie Thoracic Fixation System

- Pathway: 510(k) (Special)
- Applicant: Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices
- Decided: Jun 23, 2021 after 21 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: 15 generations back to K761228 (1976). 101 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202889: Able Medical Devices Valkyrie Thoracic Fixation System, Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices (2021) Summary page 4.

## Most influential descendants
- K232515: Valkyrie Thoracic Fixation System (2023), 0 descendants of its own

## Indications for use
The Valkyrie Thoracic Fixation System is intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

Source page: https://510kreport.com/device/K211695
Methodology: https://510kreport.com/methodology