# K110551: Expedium Spine System

- Pathway: 510(k) (Special)
- Applicant: Johnson & Johnson
- Decided: Oct 26, 2011 after 240 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: 12 generations back to K853033 (1985). 72 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063772: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 2.
- K090230: Expedium Spine System, Depuy Spine, Inc. (2009) Summary page 2.
- K092473: Expedium Spine System, Depuy Spine, Inc. (2009) Summary page 2.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001) Summary page 2.
- K023804: Moss Miami Spinal System Pin Nut, Depuyacromed (2003) Summary page 2.

## Most influential descendants
- K170821: ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System (2017), 0 descendants of its own

## Indications for use
The EXPEDIIJM 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 acuite and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM Spine System is intended for noncervical pedlicle 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; pseudlarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K110551
Methodology: https://510kreport.com/methodology