510(k) · Cleared
Recalled · 2012Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Mar 30, 2011 as substantially equivalent to K093808 (Incite Innovation, LLC, 2010) and 3 other predicates after a 218-day review. Its family tree reaches back 8 generations to 1984. 112 later devices descend from it. It has been recalled once.
- Decided
- Mar 30, 2011
- Review
- 218 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K841189 (1984). 38 ancestors in all. 112 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK043349 Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA · 2005
- 1 generation backK080572 LDR Spine Roi-a ImplantLdr Spine USA · 2008
- This deviceK102402 Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc. · 2011
- Descendant · cites it directly · 110 of its ownK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 2 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
Showing 5 of 112 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 112 · See all- K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018 · cites it directly110descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on78descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 3 generations on69descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 3 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K043349 | Open Radiotransparent Intersomatic Implant (Roi) | Ldr Spine USA | 2005 | — |
| −1 | K080572 | LDR Spine Roi-a Implant | Ldr Spine USA | 2008 | — |
| 0 (this device) | K102402 | Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System | Alphatec Spine, Inc. | 2011 | — |
| +1 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +2 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 17 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 21 | 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? (4)
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 |
|---|---|---|---|
| * | K093808 | Incite Innovation Stand Alone Interbody Fusion DeviceSummary page 2…nterior Lumbar Interbody Fusion (ALIF) System is substantially equivalent to the following predicate devices: System Clearance _ Date Incite Innovations Fusions Device K093808 March 24,2010 LDR ROI-A K080572 June 25, 2009 Synthes Spine SynFix LR Spacer K072253 October 12, 2007 glovel Anterior Lumbar I… | 2010 |
| * | K080572 | LDR Spine Roi-a ImplantSummary page 2…ALIF) System is substantially equivalent to the following predicate devices: System Clearance _ Date Incite Innovations Fusions Device K093808 March 24,2010 LDR ROI-A K080572 June 25, 2009 Synthes Spine SynFix LR Spacer K072253 October 12, 2007 glovel Anterior Lumbar Interbody Fusion (ALIF) K090782 Ap… | 2008 |
| * | K072253 | Synfix-LR SpacerSummary page 2…ing predicate devices: System Clearance _ Date Incite Innovations Fusions Device K093808 March 24,2010 LDR ROI-A K080572 June 25, 2009 Synthes Spine SynFix LR Spacer K072253 October 12, 2007 glovel Anterior Lumbar Interbody Fusion (ALIF) K090782 April 22, 2009 ystem Data was provided which demonstrat… | 2007 |
| * | K090782 | Novel Alif Spinal Spacer SystemSummary page 2…ns Device K093808 March 24,2010 LDR ROI-A K080572 June 25, 2009 Synthes Spine SynFix LR Spacer K072253 October 12, 2007 glovel Anterior Lumbar Interbody Fusion (ALIF) K090782 April 22, 2009 ystem Data was provided which demonstrated the Solus Anterior Lumbar Interbody Fusion (ALIF) System to be substan… | 2009 |
What descends from it? (112)
See all 1123 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 |
|---|---|---|---|---|
| Mar 19, 2012 | Not classified | Z-1676-2012 | Device Design | Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for twisting or bending, which has been discovered either during or after instrumentation use. A fifth complaint received in which it was… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 38 ancestors have a recall of any class.
- Of its descendants, K182746 (Alphatec Spine, Inc., 2018) has gone furthest, with 110 descendants of its own.
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. 2011, 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 Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades.
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/K102402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102402: Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102402
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