510(k) · Cleared
ClearedDyn-Alif Anterolateral Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ionics Medical Corp. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 14, 2008 as substantially equivalent to K071795 (Nuvasive, Inc., 2007) and 4 other predicates after a 154-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Nov 14, 2008
- Review
- 154 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K010930 (2001). 6 ancestors in all, the oldest P950019 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010930 | Lift VB Spinal System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −1 | K024049 | Verte-Span Spinal System | Medtronic Sofamor Danek, Inc. | 2003 | — |
| 0 (this device) | K081673 | Dyn-Alif Anterolateral Intervertebral Body Fusion Device | Ionics Medical Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 2 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K071795 | Nuvasive Coroent SystemSummary page 1…Product Code: MAX C. Predicate Devices The subject device is substantially equivalent to the NuVasive CoRoent System intervertebral body fusion device, K071795; the Surgical Dynamics Ray TFC intervertebral body fusion device, P950019/S9; the Ionics Levante Intervertebral Pillar… | 2007 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 1…antially equivalent to the NuVasive CoRoent System intervertebral body fusion device, K071795; the Surgical Dynamics Ray TFC intervertebral body fusion device, P950019/S9; the Ionics Levante Intervertebral Pillar vertebral body replacement device, K983667 and the Medtronic Sofamor Danek Vert… | 1996 |
| * | K983667 | Ionics Levante Intervertebral Pillar, ExpandableSummary page 1…71795; the Surgical Dynamics Ray TFC intervertebral body fusion device, P950019/S9; the Ionics Levante Intervertebral Pillar vertebral body replacement device, K983667 and the Medtronic Sofamor Danek Verte- Span Spinal System vertebral body replacement device, K010930 and K024049. D.… | 2000 |
| * | K010930 | Lift VB Spinal SystemSummary page 1…e Intervertebral Pillar vertebral body replacement device, K983667 and the Medtronic Sofamor Danek Verte- Span Spinal System vertebral body replacement device, K010930 and K024049. D. Device Description The Dyn-ALIF Anterolateral Intervertebral Body Fusion Device is an implantable de… | 2001 |
| * | K024049 | Verte-Span Spinal SystemSummary page 1…bral Pillar vertebral body replacement device, K983667 and the Medtronic Sofamor Danek Verte- Span Spinal System vertebral body replacement device, K010930 and K024049. D. Device Description The Dyn-ALIF Anterolateral Intervertebral Body Fusion Device is an implantable device ma… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 41 other devices also cite its predicate K071795.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion. The Dyn-ALIF device is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to SI for the treatment of degenerative disc disease (DDD) with up to grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with…
Read the full statement (130 words)
The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion.
The Dyn-ALIF device is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to SI 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 lumbar device is to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081673: Dyn-Alif Anterolateral Intervertebral Body Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081673
Report an extraction error
Are you the manufacturer?
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