510(k) · Cleared
ClearedArco™-SA Lumbar Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurostructures, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Nov 9, 2018 as substantially equivalent to K173082 (Neurostructures, Inc., 2018) and 1 other predicate after an 87-day review. Its family tree reaches back 20 generations to 1984. 1 of the 282 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Nov 9, 2018
- Review
- 87 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K841189 (1984). 278 ancestors in all. 3 later devices descend from it, 2 citing it directly. 1 of the 282 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK173082 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
- This deviceK182195 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK200541 Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK202820 Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK202190 Oculus-SA Lumbar Cage SystemNeurostructures · 2020
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK173082 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
- This deviceK182195 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 3 of 3 · See all- K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC · 2020 · cites it directly1descendant
- K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd. · 2020 · 2 generations on0descendants
- K202190Oculus-SA Lumbar Cage SystemNeurostructures · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −2 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −1 | K173082 | Arco™-SA Lumbar Cage System | Neurostructures, Inc. | 2018 | — |
| 0 (this device) | K182195 | Arco™-SA Lumbar Cage System | Neurostructures, Inc. | 2018 | — |
| +1 | K200541 | Hive™ Stand-alone Anterior Lumbar Interbody System | Hd Lifesciences, LLC | 2020 | — |
| +2 | K202820 | Australis Anterior Lumbar Cage System | Prism Surgical Designs Pty, Ltd. | 2020 | — |
| +1 | K202190 | Oculus-SA Lumbar Cage System | Neurostructures | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 16 | 0 |
| 2004 | 23 | 0 |
| 2005 | 19 | 0 |
| 2006 | 8 | 0 |
| 2007 | 14 | 0 |
| 2008 | 40 | 1 |
| 2009 | 26 | 0 |
| 2010 | 21 | 0 |
| 2011 | 20 | 0 |
| 2012 | 11 | 0 |
| 2013 | 13 | 0 |
| 2014 | 14 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K173082 | Arco™-SA Lumbar Cage SystemSummary page 5…Predicate Manufacturer Number Name Type K173082 Arco™ SA Lumbar Cage System NeuroStructures Primary K161129 PILLAR® SA PTC… | 2018 |
| * | K161129 | Pillar SA PTCSummary page 5…ame Type K173082 Arco™ SA Lumbar Cage System NeuroStructures Primary K161129 PILLAR® SA PTC Orthofix, Inc. Additional K172064 Ti-Diagon Oblique TLIF… | 2016 |
| † | K172064 | Ti-Diagon Oblique TLIF | 2017 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 33 of the 278 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200541 (Hd Lifesciences, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K173082.
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. 2018, 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 Arco™-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) on the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or…
Read the full statement (179 words)
The Arco™-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) on the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental fixation system cleared by the FDA. The Arco™-SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182195: Arco™-SA Lumbar Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182195
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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