510(k) · Cleared
ClearedNEXXT MATRIXX Stand Alone ALIF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexxt Spine, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 15, 2020 as substantially equivalent to K182139 (Innovasis, Inc., 2019) after a 130-day review. Its family tree reaches back 16 generations to 1984.
- Decided
- Dec 15, 2020
- Review
- 130 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K841189 (1984). 105 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK163269 Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS…Titan Spine, LLC · 2017
- 1 generation backK182139 AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc. · 2019
- This deviceK202230 NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC · 2020
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 3 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK163269 Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS…Titan Spine, LLC · 2017
- 1 generation backK182139 AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc. · 2019
- This deviceK202230 NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −3 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −2 | K163269 | Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS… | Titan Spine, LLC | 2017 | — |
| −1 | K182139 | AXTi Titanium Stand-Alone ALIF System | Innovasis, Inc. | 2019 | — |
| 0 (this device) | K202230 | NEXXT MATRIXX Stand Alone ALIF System | Nexxt Spine, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 14 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K182139 | AXTi Titanium Stand-Alone ALIF SystemSummary page 4…are manufactured from Ti- 6Al-4V ELI titanium alloy per F136. Primary Predicate: AXTi™ Titanium Stand-Alone ALIF System (Innovasis, Inc. – K182139) K202230 - Page 2 of 2 Perfor… | 2019 |
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 36 years and passes through 14 companies; a new generation was cleared every 1.7 years on median.
- 16 of the 105 ancestors have a recall of any class.
- 2 other devices also cite its predicate K182139.
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. 2020, 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 NEXXT MATRIXX® Stand Alone ALIF System is a stand-alone anterior lumbar interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (L2-S1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the…
Read the full statement (155 words)
The NEXXT MATRIXX® Stand Alone ALIF System is a stand-alone anterior lumbar interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (L2-S1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels and should have received at least six months of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone ALIF System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation). Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202230 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202230: NEXXT MATRIXX Stand Alone ALIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202230
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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