# K070300: Expedium SFX Cross Connector System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Apr 10, 2007 after 69 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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: 2 generations back to K955348 (1996). 3 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933881: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1994) Summary page 1.
- K062196: SFX Snap-Fit Cross Connector, Depuy Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K081153: Novel Spinal System (2009), 23 descendants of its own
- K093104: Medyssey CO., LTD., Zenius Spinal System (2010), 20 descendants of its own
- K103272: Zenius Spinal System (2010), 15 descendants of its own
- K110283: Zenius Spinal System (2011), 14 descendants of its own
- K103147: Novel Iii Spinal Fixation and Adjustable Bridge System (2010), 13 descendants of its own

## Recalls of this device
- Feb 11, 2009 · Not classified · Z-1670-2009: Tip of Driver may break during use

## Indications for use
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM 5.5mm and 6.35mm Spine Systems. The uses of the legally marketed EXPEDIUM 5.5mm and 6.35mm, Spine System are as follows: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available VSP Spine System. The uses of the legally marketed VSP Spine System are as follows: The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The VSP Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grade 3 and 4) at L5-S1, in skeletally mature patients, when autogeous bone graft is used, when affixed to the posterior lumbosacral spin, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available ISOLA 6.35mm Spine System. The uses of the legally marketed ISOLA 6.35mm Spine System are as follows: The ISOLA Spine Systems 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 ISOLA Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S I 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 ISOLA Spine Systems 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 ISOLA Spinal System when used with pedicle screws is 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 EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available MOSS Miami 6.35mm Spine System. The uses of the legally marketed MOSS Miami 6.35mm Spine System are as follows: When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami 6.35mm Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies). When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS Miami 6.35mm Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). The MOSS Miami 6.35mm Spine Systems is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S 1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1) and for whom the device system is intended to be removed after solid fusion is attained.

Source page: https://510kreport.com/device/K070300
Methodology: https://510kreport.com/methodology