510(k) · Cleared
ClearedCortina™ Lumbar Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurostructures, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 25, 2017 as substantially equivalent to K113478 (Eisertech, LLC, 2012) and 6 other predicates after a 121-day review. Its family tree reaches back 16 generations to 1984. 2 later devices descend from it.
- Decided
- Oct 25, 2017
- Review
- 121 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 16 generations to K841189 (1984). 84 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 2 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 1 generation backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- This deviceK171914 Cortina™ Lumbar Cage SystemNeurostructures, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK180431 Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK192248 Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc. · 2019
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 backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 5 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 4 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 3 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 2 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 1 generation backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- This deviceK171914 Cortina™ Lumbar Cage SystemNeurostructures, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView 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 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −5 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −4 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −3 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −2 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −1 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| 0 (this device) | K171914 | Cortina™ Lumbar Cage System | Neurostructures, Inc. | 2017 | — |
| +1 | K180431 | Cortina [MAX] Lumbar Cage System | Neurostructures, Inc. | 2018 | — |
| +1 | K192248 | Cortina™ [MAX] Lumbar Cage System | Neurostructures, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 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? (7)
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 |
|---|---|---|---|
| * | K113478 | Plif CageSummary page 5…er Trade or Proprietary or Model Manufacturer Predicate Name Type K113478 PLIF Cage Eisertech Primary K072791 OPAL Spacer… | 2012 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 5…Name Type K113478 PLIF Cage Eisertech Primary K072791 OPAL Spacer Synthes Additional K141217 AccuLIF® TL an… | 2007 |
| * | K141217 | Acculif TL and PL CageSummary page 5…PLIF Cage Eisertech Primary K072791 OPAL Spacer Synthes Additional K141217 AccuLIF® TL and PL Cage Stryker Additional K071724 Lucent Cage… | 2014 |
| * | K071724 | LucentSummary page 5…OPAL Spacer Synthes Additional K141217 AccuLIF® TL and PL Cage Stryker Additional K071724 Lucent Cage Spinal Element Additional K112095 AccuLiF® TL-PE… | 2007 |
| * | K112095 | Acculif TL-Peek Ibf CageSummary page 5…AccuLIF® TL and PL Cage Stryker Additional K071724 Lucent Cage Spinal Element Additional K112095 AccuLiF® TL-PEEK Cage and CoAlign… | 2011 |
| * | K123281 | Acculif TL-Peek CageSummary page 5…l K112095 AccuLiF® TL-PEEK Cage and CoAlign Additional K123281 K123752 AccuLiF® TL and P Innovation PERFORMANCE DATA The Cortina™ Lumbar Cage System has been t… | 2013 |
| * | K123752 | Acculif TL and PL CageSummary page 5…95 AccuLiF® TL-PEEK Cage and CoAlign Additional K123281 K123752 AccuLiF® TL and P Innovation PERFORMANCE DATA The Cortina™ Lumbar Cage System has been tested in… | 2013 |
What descends from it? (2)
2 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)
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 33 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 9 of the 84 ancestors have a recall of any class.
- Of its descendants, K180431 (Neurostructures, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K113478.
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. 2017, 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 Cortina™ Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171914: Cortina™ Lumbar 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/K171914
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