# K252729: Universal Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Nov 18, 2025 after 82 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: 19 generations back to K040583 (2004). 221 ancestors in all.
No later device cites it as a predicate yet.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040072: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 5.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 5.
- K222473: EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods, Medos-International Sarl (2022) Summary page 5.
- K963655: CD Horizon Anterior Spinal System, Sofamor Danek USA,Inc. (1996) Summary page 5.

## Indications for use
The Universal Spinal System is intended for non-cervical posterior and anterolateral fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Universal Spinal System is 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 Universal 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. The HOBBIT Growth Connectors are indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis, as part of a growing rod construct.

Source page: https://510kreport.com/device/K252729
Methodology: https://510kreport.com/methodology