# K033901: Merlin Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Mar 31, 2004 after 105 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
No predicates in its family tree.
737 later devices descend from it; 35 cite it directly.
1 of 738 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041119: Expedium Spine System (2004), 640 descendants of its own
- K071495: Expedium 4.5MM Spine System (2007), 539 descendants of its own
- K073364: Expedium 4.5MM Spine System (2008), 538 descendants of its own
- K041801: Expedium Mis Spine System (2004), 533 descendants of its own
- K082942: Modfication to: Expedium Spine System (2008), 518 descendants of its own

## Indications for use
The Merlin Spinal 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.

Source page: https://510kreport.com/device/K033901
Methodology: https://510kreport.com/methodology