510(k) · Cleared
Recalled · 2009Expedium SFX Cross Connector System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Apr 10, 2007 as substantially equivalent to K933881 (Depuy, Inc., 1994) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 1996. 31 later devices descend from it. It has been recalled once.
- Decided
- Apr 10, 2007
- Review
- 69 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955348 (1996). 3 ancestors in all, the oldest K933881 (1994). 31 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 1 generation backK062196 SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006
- This deviceK070300 Expedium SFX Cross Connector SystemDepuy Spine, Inc. · 2007
- Descendant · cites it directly · 23 of its ownK081153 Novel Spinal SystemMedyssey Co, Ltd. · 2009
- Descendant · 2 generations on · 20 of its ownK093104 Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd. · 2010
- Descendant · 3 generations on · 15 of its ownK103272 Zenius Spinal SystemMedyssey Co, Ltd. · 2010
- Descendant · 3 generations on · 14 of its ownK110283 Zenius Spinal SystemMedyssey Co, Ltd. · 2011
- Descendant · 2 generations on · 13 of its ownK103147 Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd. · 2010
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K081153Novel Spinal SystemMedyssey Co, Ltd. · 2009 · cites it directly23descendants
- K093104Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd. · 2010 · 2 generations on20descendants
- K103272Zenius Spinal SystemMedyssey Co, Ltd. · 2010 · 3 generations on15descendants
- K110283Zenius Spinal SystemMedyssey Co, Ltd. · 2011 · 3 generations on14descendants
- K103147Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd. · 2010 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −1 | K062196 | SFX Snap-Fit Cross Connector | Depuy Spine, Inc. | 2006 | — |
| 0 (this device) | K070300 | Expedium SFX Cross Connector System | Depuy Spine, Inc. | 2007 | — |
| +1 | K081153 | Novel Spinal System | Medyssey Co, Ltd. | 2009 | — |
| +2 | K093104 | Medyssey CO., LTD., Zenius Spinal System | Medyssey Co, Ltd. | 2010 | — |
| +3 | K103272 | Zenius Spinal System | Medyssey Co, Ltd. | 2010 | — |
| +3 | K110283 | Zenius Spinal System | Medyssey Co, Ltd. | 2011 | — |
| +2 | K103147 | Novel Iii Spinal Fixation and Adjustable Bridge System | Medyssey Co, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933881 | Depuy Motech Moss-Miami Spinal SystemSummary page 1…de(s): KWP, KWQ, MNH-, NMI, NKB Proprietary Name: EXPEDIUM SFX Cross Connector System Predicate Devices: DePuy Motech MOSS MIAMI Spinal System (K933881), SEX Snap-Fit Cross Connector System (K062 196) Device Description: The EXPEDIUM SFX Cross Co… | 1994 |
| * | K062196 | SFX Snap-Fit Cross ConnectorSummary page 1…SFX Cross Connector System Predicate Devices: DePuy Motech MOSS MIAMI Spinal System (K933881), SEX Snap-Fit Cross Connector System (K062 196) Device Description: The EXPEDIUM SFX Cross Connector System is designed to transversely connect… | 2006 |
What descends from it? (31)
See all 313 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2009 | Not classified | Z-1670-2009 | Nonconforming Material/Component | Tip of Driver may break during use |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K081153 (Medyssey Co, Ltd., 2009) has gone furthest, with 23 descendants of its own.
- 14 other devices also cite its predicate K933881.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (774 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070300: Expedium SFX Cross Connector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070300
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026