510(k) · Cleared
ClearedNeo Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neo Medical SA · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 13, 2019 as substantially equivalent to K181048 (Neo Medical SA, 2019) and 5 other predicates after a 163-day review. Its family tree reaches back 20 generations to 1984. 1 of the 172 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 13, 2019
- Review
- 163 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 20 generations to K841189 (1984). 171 ancestors in all. No later device cites it as a predicate yet. 1 of the 172 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 backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 2 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 1 generation backK181048 Neo Cage System TMNeo Medical SA · 2019
- This deviceK191796 Neo Cage SystemNeo Medical SA · 2019
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 backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 2 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 1 generation backK181048 Neo Cage System TMNeo Medical SA · 2019
- This deviceK191796 Neo Cage SystemNeo Medical SA · 2019
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
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 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −2 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −1 | K181048 | Neo Cage System TM | Neo Medical SA | 2019 | — |
| 0 (this device) | K191796 | Neo Cage System | Neo Medical SA | 2019 | — |
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 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 25 | 1 |
| 2009 | 13 | 0 |
| 2010 | 9 | 0 |
| 2011 | 12 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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.
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 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? (6)
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 |
|---|---|---|---|
| * | K181048 | Neo Cage System TMSummary page 4…bmission 510(k) type Traditional 510(k) Purpose of submission Line extension to currently cleared NEO Cage SystemTM K181048 Submitter information Submitter Neo Medical S.A. Route de Lausanne 157 A… | 2019 |
| * | K152304 | Tritanium PL CageSummary page 4…TM is substantially equivalent to the primary predicate device NEO Cage SystemTM (K181048) as well as the following additional predicate devices: Stryker Tritanium Cage (K152304), Spineart Juliet Ti (K153621), Medtronic Capstone (K073291 (initial), K082342 (PEEK introduced)) and SpineVision SpaceVision Sys… | 2015 |
| * | K153621 | Juliet® TiSummary page 4…to the primary predicate device NEO Cage SystemTM (K181048) as well as the following additional predicate devices: Stryker Tritanium Cage (K152304), Spineart Juliet Ti (K153621), Medtronic Capstone (K073291 (initial), K082342 (PEEK introduced)) and SpineVision SpaceVision System (K153783).… | 2016 |
| * | K073291 | Capstone Spinal SystemSummary page 4…ce NEO Cage SystemTM (K181048) as well as the following additional predicate devices: Stryker Tritanium Cage (K152304), Spineart Juliet Ti (K153621), Medtronic Capstone (K073291 (initial), K082342 (PEEK introduced)) and SpineVision SpaceVision System (K153783).… | 2008 |
| * | K082342 | Modification to Capstone Spinal SystemSummary page 4…M (K181048) as well as the following additional predicate devices: Stryker Tritanium Cage (K152304), Spineart Juliet Ti (K153621), Medtronic Capstone (K073291 (initial), K082342 (PEEK introduced)) and SpineVision SpaceVision System (K153783).… | 2008 |
| * | K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSummary page 4…es: Stryker Tritanium Cage (K152304), Spineart Juliet Ti (K153621), Medtronic Capstone (K073291 (initial), K082342 (PEEK introduced)) and SpineVision SpaceVision System (K153783). K191796… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 23 of the 171 ancestors have a recall of any class; 1 has a Class I recall.
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. 2019, 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?
NEO Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach. The indication for use is Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may…
Read the full statement (119 words)
NEO Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.
The indication for use is Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191796: Neo Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191796
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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