# K130877: Expedium Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jun 20, 2013 after 83 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: 13 generations back to K853033 (1985). 79 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 2.
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 2.
- K071495: Expedium 4.5MM Spine System, Depuy Spine, A Johnson & Johnson Company (2007) Summary page 2.
- K073364: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 2.
- K082942: Modfication to: Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 2.
- K090230: Expedium Spine System, Depuy Spine, Inc. (2009) Summary page 2.
- K101070: Expedium Spine System, Medos International SARL (2010) Summary page 2.
- K111136: Expedium Spine System, Viper System, Viper 2 System, Depuy Spine, Inc. (2012) Summary page 2.

## Most influential descendants
- K170163: Erisma® LP Spinal Fixation System (2017), 2 descendants of its own
- K141291: Vertiform Posterior Fixation System (2014), 2 descendants of its own
- K240872: Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (2024), 1 descendant of its own
- K161499: VertiForm Posterior Fixation System (2016), 1 descendant of its own
- K241863: Erisma® Lp Spinal Fixation System; Erisma® LP MIS (2024), 0 descendants 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 {ordosis); 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 metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM 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/K130877
Methodology: https://510kreport.com/methodology