510(k) · Cleared
ClearedVisualif Challenging Access Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Smith Partners L.P. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Oct 11, 2012 as substantially equivalent to K102090 (Spine Smith Partners L.P., 2010) after an 80-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Oct 11, 2012
- Review
- 80 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P950002 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 2 generations backK090376 Spinesmith Cynch Spinal SystemSpine Smith Partners L.P. · 2009
- 1 generation backK102090 Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant…Spine Smith Partners L.P. · 2010 · Recalled
- This deviceK122168 Visualif Challenging Access PlateSpine Smith Partners L.P. · 2012
- Descendant · cites it directly · 0 of its ownK161993 Leva® Anterior Interbody SystemSpine Wave, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161993Leva® Anterior Interbody SystemSpine Wave, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −2 | K090376 | Spinesmith Cynch Spinal System | Spine Smith Partners L.P. | 2009 | — |
| −1 | K102090 | Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System | Spine Smith Partners L.P. | 2010 | 1 |
| 0 (this device) | K122168 | Visualif Challenging Access Plate | Spine Smith Partners L.P. | 2012 | — |
| +1 | K161993 | Leva® Anterior Interbody System | Spine Wave, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 OVD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K102090 | Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSummary page 1…ICATION OF PREDICATE DEVICES: The SpineSmith VisuALIF Challenging Access System was determined to be substantially equivalent to the previously cleared VisuALI F System (K1 02090, SpineSmith; Cleared 09/09/2010). DEVICE DESCRIPTION: The VisuALIF Challenging Access System an extension to the Vis uALIF System… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161993 | Leva® Anterior Interbody System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K161993 (Spine Wave, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K102090.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The VisuALIF System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
Read the full statement (172 words)
The VisuALIF System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with autograft to facilitate fusion.
The VisuALIF is a stand-alone device intended to be used with an anterior cover plate and a minimum of two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122168: Visualif Challenging Access Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122168
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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