# K253545: Vulcan Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Feb 10, 2026 after 88 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K853033 (1985). 837 ancestors in all.
No later device cites it as a predicate yet.
2 of 838 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132757: Everest Spinal System, K2m, Inc. (2013) Summary page 5.
- K242361: OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI, Stryker Spine (2024) Summary page 5.
- K170496: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory, Stryker Corporation (2017) Summary page 5.

## Indications for use
The Vulcan Spinal System is intended for posterior, non-cervical, pedicle fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vulcan Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Vulcan Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Refer to the Compatibility section of the VB Spine Vulcan Spinal System Instructions for Use for a listing of compatible systems.

Source page: https://510kreport.com/device/K253545
Methodology: https://510kreport.com/methodology