510(k) · Cleared
ClearedEVOL ha - D Lateral Interbody Fusion 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 Jan 6, 2020 as substantially equivalent to K153782 (Nu Vasive, Incorporated, 2016) and 2 other predicates after a 117-day review. Its family tree reaches back 18 generations to 1984. 1 later device descends from it.
- Decided
- Jan 6, 2020
- Review
- 117 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K841189 (1984). 203 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- This deviceK192497 EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC · 2020
- Descendant · cites it directly · 0 of its ownK200991 EVOL Spinal Interbody SystemCutting Edge Spine, LLC · 2020
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 5 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 4 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- This deviceK192497 EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC · 2020
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 |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −5 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −4 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −3 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −1 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K192497 | EVOL ha - D Lateral Interbody Fusion System | Cutting Edge Spine, LLC | 2020 | — |
| +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 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 13 | 0 |
| 2004 | 14 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 12 | 0 |
| 2008 | 31 | 0 |
| 2009 | 20 | 0 |
| 2010 | 12 | 0 |
| 2011 | 14 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 10 | 0 |
| 2015 | 3 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K153782 | NuVasive® Lumbar Interbody ImplantsSummary page 5…510(k) Number Device Manufacturer Primary Lumbar Interbody K153782 NuVasive Predicate Implants Addition… | 2016 |
| * | K180674 | EVOL® ha-C Cervical Interbody Fusion SystemSummary page 5…NuVasive Predicate Implants Additional EVOL® ha – C Cervical K180674 Cutting Edge Spine Predicate Interbody Fusion System… | 2018 |
| * | K102957 | Cutting Edge Spine Interbody Fusion DeviceSummary page 5…ne Predicate Interbody Fusion System Additional Spinal Interbody Device K102957 Cutting Edge Spine Predicate (EVOL) IV. DEVI… | 2011 |
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 36 years and passes through 13 companies; a new generation was cleared every 1.0 years on median.
- 23 of the 203 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 K153782.
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. 2020, 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® ha – D Lateral Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. EVOL® ha – D Lateral Interbody Fusion System is indicated for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by…
Read the full statement (142 words)
The EVOL® ha – D Lateral Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. EVOL® ha – D Lateral Interbody Fusion System is indicated for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha – D Lateral Interbody Fusion System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192497: EVOL ha - D Lateral Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192497
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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