# K202889: Able Medical Devices Valkyrie Thoracic Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
- Decided: Mar 2, 2021 after 155 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: 14 generations back to K761228 (1976). 100 ancestors in all.
39 later devices descend from it; 3 cite it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163007: Biomet Microfixation SternaLock 360 Sternal Closure System, Biomet Microfixation (2016) Summary page 5.
- K151019: SternaLock® 360 Sternal Closure System, Biomet Microfixation (2015) Summary page 5.
- K121302: Biomet Microfixation Sternal Closure System, Biomet Microfixation (2012) Summary page 5.
- K110574: Biomet Microfixation Sternalock Blu Sternal Closure System, Biomet Microfixation, Inc. (2011) Summary page 5.
- K193468: Tritium Sternal Cable Plate System, Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (2020) Summary page 5.
- K133785: Tritium Sternal Cable Plate System, Pioneer Surgical Technology, Inc. (2014) Summary page 5.
- K151983: KLS Martin LSS Plating System, KLS Martin L.P. (2016) Summary page 5.
- K170767: Surgical Stainless Steel Suture, Stainless Steel Suture, ETHICON, Inc. (2017) Summary page 5.

## Most influential descendants
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own
- K222973: IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem (2022), 13 descendants of its own
- K232432: E3D™-A Interbody System (2024), 8 descendants of its own
- K240368: E3D™-A Interbody System (2024), 7 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/K202889
Methodology: https://510kreport.com/methodology