# K213820: BALTEUM - ONE™ Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Huvexel Co., Ltd.
- Decided: Mar 25, 2022 after 107 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K990745 (1999). 23 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200846: Balteum™ Lumbar Plate System, Huvexel Co., Ltd. (2020) Summary page 5.
- K120092: Plymouth Thoracolumbar Plate System, Globus Medical, Inc. (2012) Summary page 5.
- K092108: Truss Thoracolumbar Plate System, Globus Medical, Inc. (2009) Summary page 5.
- K091071: Nuvasive Lateral Plate System, Nuvasive, Inc. (2009) Summary page 5.
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 5.

## Most influential descendants
- K222572: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System (2022), 2 descendants of its own
- K250446: Frida™ Anterior Cervical Plate System (2025), 0 descendants of its own
- K231460: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System (2023), 0 descendants of its own

## Indications for use
The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1‐L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1‐S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

Source page: https://510kreport.com/device/K213820
Methodology: https://510kreport.com/methodology