510(k) · Cleared
ClearedEVOS Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutting Edge Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 13, 2015 as substantially equivalent to K102957 (Cutting Edge Spine, LLC, 2011) and 3 other predicates after a 154-day review. Its family tree reaches back 12 generations to 1984. 92 later devices descend from it.
- Decided
- Jul 13, 2015
- Review
- 154 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K841189 (1984). 60 ancestors in all. 92 later devices descend from it, 9 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 1 generation backK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- This deviceK150321 EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2015
- Descendant · cites it directly · 50 of its ownK153615 NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC · 2016
- Descendant · 2 generations on · 49 of its ownK170318 NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017
- Descendant · 3 generations on · 37 of its ownK192115 SABLE Expandable SpacerGlobus Medical, Inc. · 2020
- Descendant · 4 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · cites it directly · 22 of its ownK172947 HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2018
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 1 generation backK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- This deviceK150321 EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2015
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC · 2016 · cites it directly50descendants
- K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017 · 2 generations on49descendants
- K192115SABLE Expandable SpacerGlobus Medical, Inc. · 2020 · 3 generations on37descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 4 generations on23descendants
- K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2018 · cites it directly22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −1 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| 0 (this device) | K150321 | EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | 2015 | — |
| +1 | K153615 | NeoFuse HA Enhanced PLIF/TLIF | Ht Medical, LLC | 2016 | — |
| +2 | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | Ht Medical, LLC | 2017 | — |
| +3 | K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | 2020 | — |
| +4 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +1 | K172947 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | 2018 | — |
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 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 14 | 0 |
| 2024 | 12 | 0 |
| 2025 | 15 | 0 |
| 2026 | 14 | 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? (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 |
|---|---|---|---|
| * | K102957 | Cutting Edge Spine Interbody Fusion DeviceSummary page 4…510(k) Number Device Manufacturer Primary EVOL Intervertebral Body K102957 Cutting Edge Spine, LLC Predicate Fusion Device… | 2011 |
| * | K071724 | LucentSummary page 4…g Edge Spine, LLC Predicate Fusion Device Additional Lucent Intervertebral Body K071724 Spinal Elements Predicate Fusion Device A… | 2007 |
| * | K073291 | Capstone Spinal SystemSummary page 4…071724 Spinal Elements Predicate Fusion Device Additional K073291 Capstone Spinal System Medtronic Predicate Additional Capstone Con… | 2008 |
| * | K120368 | Capstone Control Spinal SystemSummary page 4…3291 Capstone Spinal System Medtronic Predicate Additional Capstone Control Spinal K120368 Medtronic Predicate System No refer… | 2012 |
What descends from it? (92)
See all 929 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153615 | NeoFuse HA Enhanced PLIF/TLIF | 2016 | 50 |
| K172947 | HALF DOME Posterior Lumbar Interbody System | 2018 | 22 |
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | 2017 | 4 |
| K180674 | EVOL® ha-C Cervical Interbody Fusion System | 2018 | 3 |
| K163670 | Rampart One Lumbar Interbody Fusion Device | 2017 | 3 |
| K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | 2018 | 1 |
| K172349 | InFill® Interbody Fusion Device | 2017 | 1 |
| K160631 | Keos Lumbar IBFD | 2016 | 1 |
| K200552 | EVOS Lumbar Interbody System | 2020 | 0 |
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 31 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 60 ancestors have a recall of any class.
- Of its descendants, K153615 (Ht Medical, LLC, 2016) has gone furthest, with 50 descendants of its own.
- 4 other devices also cite its predicate K102957.
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. 2015, 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 EVOS Lumbar Interbody System (EVOS device) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The EVOS Lumbar Interbody System is intended to be used…
Read the full statement (145 words)
The EVOS Lumbar Interbody System (EVOS device) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The EVOS Lumbar Interbody System is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.
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/K150321 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150321: EVOS Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150321
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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