# K200245: EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International Sàrl
- Decided: Apr 24, 2020 after 84 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: 17 generations back to K040583 (2004). 219 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 232 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162494: CD HORIZON® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 5.
- K142381: Xia 3 Spinal System, Stryker Corp. (2014) Summary page 5.
- K160904: Expedium Spine System, VIPER and VIPER 2 Systems, Medos International SARL (2016) Summary page 5.
- K142185: Expedium Verse Spine System, Depuy Spine, Inc. (2014) Summary page 5.

## Most influential descendants
- K220374: EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) (2022), 9 descendants of its own
- K231479: TriALTIS Spine System (2023), 8 descendants of its own
- K233684: TriALTIS™ Spine System (2023), 4 descendants of its own
- K253990: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 2 descendants of its own
- K260786: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 1 descendant of its own

## Indications for use
The EXPEDIUM® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM® Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM® System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e, scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM® System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The EXPEDIUM VERSE® System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM VERSE® System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM VERSE® System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM VERSE® System metallic implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e, scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM VERSE® system is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM VERSE® system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K200245
Methodology: https://510kreport.com/methodology