510(k) · Cleared
ClearedSFX Snap-Fit Cross Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 11, 2006 as substantially equivalent to K955348 (Depuy, Inc., 1996) after a 41-day review. Its family tree reaches back 1 generation to 1996. 1 of the 561 devices in its family, counting itself, has a Class I recall. 559 later devices descend from it.
- Decided
- Sep 11, 2006
- Review
- 41 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955348 (1996). 559 later devices descend from it, 6 citing it directly. 1 of the 561 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- This deviceK062196 SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006
- Descendant · cites it directly · 539 of its ownK071495 Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company · 2007
- Descendant · cites it directly · 538 of its ownK073364 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- Descendant · 2 generations on · 337 of its ownK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
Showing 5 of 559 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 559 · See all- K071495Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company · 2007 · cites it directly539descendants
- K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008 · cites it directly538descendants
- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 2 generations on518descendants
- K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · 2 generations on462descendants
- K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · 2 generations on337descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| 0 (this device) | K062196 | SFX Snap-Fit Cross Connector | Depuy Spine, Inc. | 2006 | — |
| +1 | K071495 | Expedium 4.5MM Spine System | Depuy Spine, A Johnson & Johnson Company | 2007 | — |
| +1 | K073364 | Expedium 4.5MM Spine System | Depuy Spine, Inc. | 2008 | — |
| +2 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +2 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +2 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 11 | 0 |
| 2011 | 11 | 0 |
| 2012 | 21 | 0 |
| 2013 | 29 | 0 |
| 2014 | 18 | 0 |
| 2015 | 28 | 0 |
| 2016 | 24 | 0 |
| 2017 | 37 | 0 |
| 2018 | 37 | 0 |
| 2019 | 35 | 0 |
| 2020 | 34 | 0 |
| 2021 | 27 | 1 |
| 2022 | 35 | 0 |
| 2023 | 55 | 0 |
| 2024 | 52 | 0 |
| 2025 | 44 | 0 |
| 2026 | 46 | 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…xation PROPRIETARY NAME: SFX Snap-Fit Cross Connector PREDICATE DEVICES: MOSS MIAMI Spinal System Transverse Connector (K955348). DEVICE DESCRIPTION: The SFX Connector is designed to transversely connect two rods used in spinal… | 1996 |
What descends from it? (559)
See all 5596 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071495 | Expedium 4.5MM Spine System | 2007 | 539 |
| K073364 | Expedium 4.5MM Spine System | 2008 | 538 |
| K070300 | Expedium SFX Cross Connector System | 2007 | 31 |
| K120891 | Tangors Multifunctional Posterior System | 2012 | 18 |
| K090799 | Modification to Expedium Spine System | 2009 | 4 |
| K160926 | F1 MPS Modular Pedicle Screw System | 2016 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available VIPERTM System. The uses of the legally marketed VIPERTM System are as follows: The VIPER Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc…
Read the full statement (1,445 words)
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available VIPERTM System. The uses of the legally marketed VIPERTM System are as follows:
The VIPER 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.
When used in a percutaneous, posterior approach with MIS instrumentation, the VIPER 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 SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available VSP® 6.35mm 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 SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector 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 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 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 SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available MOSS® MIAMI 5.5mm and 6.35mm Spine Systems.
The uses of the legally marketed MOSS MIAMI 5.5mm and 6.35mm Spine Systems 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 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 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 Spine Systems is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 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.
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available MONARCH® 5.5mm and 6.35mm Spine Systems.
The uses of the legally marketed MONARCH 5.5mm and 6.35mm Spine Systems are as follows:
The MONARCH Spine Systems is a pedlicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion inthe 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 Spine Systems is also indicated for pedlicie 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 (L_3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The MONARCH 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, lordlosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The MONARCH Spine System when used with pedlicle 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 SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available TIMX® 6.35mm Spine System.
The uses of the legally marketed TIMX Spine System are as follows:
The TIMX 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 TIMX Spine Systems is also indicated for pedlicle 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 TIMX 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, lordlosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available EXPEDIUM™ 5.5mm Spine System.
The uses of the legally marketed EXPEDIUM™ 5.5mm 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062196: SFX Snap-Fit Cross Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062196
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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