# K101070: Expedium Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Aug 31, 2010 after 137 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K853033 (1985). 77 ancestors in all.
260 later devices descend from it; 5 cite it directly.
1 of 338 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092473: Expedium Spine System, Depuy Spine, Inc. (2009) Summary page 3.
- K090230: Expedium Spine System, Depuy Spine, Inc. (2009)
- K080313: Modification to Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 3.
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006)
- K071495: Expedium 4.5MM Spine System, Depuy Spine, A Johnson & Johnson Company (2007) Summary page 3.
- K013441: Isola Polyaxial Washer, Depuyacromed (2001)
- K010972: Isola Band Clamp, Depuyacromed (2001) Summary page 3.
- K980485: Isola Spinal System, Acromed Corp. (1998) Summary page 3.
- K024348: Monarch Spine System, Depuyacromed (2003) Summary page 3.
- K010576: Monarch Spine System, Depuyacromed (2001) Summary page 3.
- K984350: VSP System, Depuy Motech Acromed (1999) Summary page 3.
- K981274: Acromed Timx Plate Based Low Back System, Acromed Corp. (1998) Summary page 3.

## Most influential descendants
- K122226: Revere Stabilization System (2012), 225 descendants of its own
- K124058: Creo Stabilization System (2013), 172 descendants of its own
- K143633: CREO Stabilization System (2015), 158 descendants of its own
- K123783: Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants (2013), 97 descendants of its own
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS (2015), 96 descendants of its own

## Recalls of this device
- Apr 21, 2015 · Class II · Z-1674-2015: Device does not mate as intended.

## 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; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K101070
Methodology: https://510kreport.com/methodology