# K052131: Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Sep 28, 2005 after 54 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944736 (1995). 14 ancestors in all.
495 later devices descend from it; 2 cite it directly.
1 of 510 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.
- K024348: Monarch Spine System, Depuyacromed (2003) Summary page 1.
- K021148: Monarch Spine System Commercially Pure Titanium Spinal Rod, Depuyacromed (2002) Summary page 1.

## Most influential descendants
- K062174: Modification to Expedium Spine System (2006), 490 descendants of its own
- K063156: Modification to Expedium Spine System (2006), 424 descendants of its own
- K063741: Expedium Spine System (2007), 398 descendants of its own
- K080313: Modification to Expedium Spine System (2008), 397 descendants of its own
- K063772: Expedium Spine System (2007), 264 descendants of its own

## Indications for use
The EXPEDIUM TM 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. The MONARCH TM Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis) The MONARCH TM Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion The MONARCH TM Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis) tumor, and previous failed fusion (pseudarthrosis) The MONARCH Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) Levels of fixation are for the thoracic lumbar and sacral spine The MONARCH Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4 75mm, 5.5mm, and 6 35mm diameter rod systems The EXPEDIUM TM Spine System 5 5ram Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MONARCH TM Spine System which can accept a 5 5 mm diameter rod The MOSS MIAMITM Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The MOSS MIAMI"T' Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion The MOSS MIAMI" Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis) tumor, and previous failed fusion (pseudarthrosis). The EXPEDIUM TM Spine System 5 5nmi Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MOSS MIAMI TM Spine System which can accept a 5 5 mm diameter rod

Source page: https://510kreport.com/device/K052131
Methodology: https://510kreport.com/methodology