510(k) · Cleared
ClearedEVOL Spinal Interbody System, EVOS 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 May 4, 2018 as substantially equivalent to K102957 (Cutting Edge Spine, LLC, 2011) and 2 other predicates after a 29-day review. Its family tree reaches back 19 generations to 1984. 1 later device descends from it.
- Decided
- May 4, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K841189 (1984). 156 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK170395 Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC · 2017
- This deviceK180891 EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2018
- Descendant · cites it directly · 0 of its ownK200991 EVOL Spinal Interbody SystemCutting Edge Spine, LLC · 2020
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK170395 Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC · 2017
- This deviceK180891 EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −1 | K170395 | Talos® Lumbar (HA) PEEK IBF Devices | Meditech Spine, LLC | 2017 | — |
| 0 (this device) | K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | 2018 | — |
| +1 | K200991 | EVOL Spinal Interbody System | Cutting Edge 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 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 17 | 0 |
| 2005 | 12 | 0 |
| 2006 | 1 | 0 |
| 2007 | 8 | 0 |
| 2008 | 21 | 0 |
| 2009 | 16 | 0 |
| 2010 | 8 | 0 |
| 2011 | 9 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (3)
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 6…Device Manufacturer Number Primary Cutting Edge Spine K102957 Cutting Edge Spine Predicate Interbody Device… | 2011 |
| * | K150321 | EVOS Lumbar Interbody SystemSummary page 6…ng Edge Spine Predicate Interbody Device Additional EVOS Lumbar K150321 Cutting Edge Spine Predicate Interbody System… | 2015 |
| * | K170395 | Talos® Lumbar (HA) PEEK IBF DevicesSummary page 6…ate Interbody System Additional Talos® Intervertebral Meditech Spine, K170395 Predicate Body Fusion Devices LLC IV. DEVICE DESCRIPTION a. EVOL… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200991 | EVOL Spinal 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 34 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 14 of the 156 ancestors have a recall of any class.
- Of its descendants, K200991 (Cutting Edge Spine, LLC, 2020) has gone furthest, with 0 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. 2018, 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 EVOL® Spinal Interbody System 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 EVOL® Spinal Interbody System is intended to be used with…
Read the full statement (305 words)
The EVOL® Spinal Interbody System 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 EVOL® Spinal Interbody System is intended to be used with autograft and/or allograft comprised of cancellous and/
or corticocancellous 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, transforaminal, retroperitoneal or anterior approach. The CES‐
PLIF and CES‐LIF are implanted in pairs, while the CES‐TLIF, CES‐CLIF and CES‐RLIF devices may be implanted
singly or in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with
supplemental fixation.
The EVOS Lumbar Interbody System 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 autograft and/or allograft comprised of cancellous and/
or corticocancellous 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 as stated in the FDA summary.
https://510kreport.com/device/K180891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180891: EVOL Spinal Interbody System, EVOS Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180891
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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