510(k) · Cleared
ClearedImpulse Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Degen Medical · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 22, 2020 as substantially equivalent to K130478 (Globus Medical, Inc., 2013) and 4 other predicates after a 222-day review. Its family tree reaches back 25 generations to 1984. 1 of the 426 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Dec 22, 2020
- Review
- 222 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 25 generations to K841189 (1984). 417 ancestors in all, the oldest K792352 (1979). 8 later devices descend from it, 1 citing it directly. 1 of the 426 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 1 generation backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- This deviceK201287 Impulse Interbody Fusion SystemDegen Medical · 2020
- Descendant · cites it directly · 7 of its ownK210090 Impulse AM Interbody Fusion SystemDegen Medical · 2021
- Descendant · 2 generations on · 6 of its ownK223418 DeGen Impulse AM™ SystemDegen Medical · 2023
- Descendant · 2 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
- Descendant · 3 generations on · 4 of its ownK240326 Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK241077 DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2024
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 5 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 1 generation backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- This deviceK201287 Impulse Interbody Fusion SystemDegen Medical · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
Most influential descendants
Showing 5 of 8 · See all- K210090Impulse AM Interbody Fusion SystemDegen Medical · 2021 · cites it directly7descendants
- K223418DeGen Impulse AM™ SystemDegen Medical · 2023 · 2 generations on6descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 2 generations on5descendants
- K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024 · 3 generations on4descendants
- K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −2 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −1 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| 0 (this device) | K201287 | Impulse Interbody Fusion System | Degen Medical | 2020 | — |
| +1 | K210090 | Impulse AM Interbody Fusion System | Degen Medical | 2021 | — |
| +2 | K223418 | DeGen Impulse AM™ System | Degen Medical | 2023 | — |
| +2 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
| +3 | K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 | — |
| +3 | K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 19 | 0 |
| 2004 | 30 | 0 |
| 2005 | 22 | 0 |
| 2006 | 16 | 0 |
| 2007 | 18 | 0 |
| 2008 | 50 | 1 |
| 2009 | 31 | 0 |
| 2010 | 20 | 0 |
| 2011 | 24 | 0 |
| 2012 | 15 | 0 |
| 2013 | 21 | 0 |
| 2014 | 20 | 0 |
| 2015 | 12 | 0 |
| 2016 | 8 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K130478 | Sustain and Sustain Radiolucent SpacersSummary page 4…tervertebral body fusion device MAX Code–Classification 21 CFR 888.3080 : Class II Primary Predicate Globus Sustain K130478 Medtronic Capstone K073291 Astura Medical Half Dome K163481 Additional Predicates… | 2013 |
| * | K073291 | Capstone Spinal SystemSummary page 4…MAX Code–Classification 21 CFR 888.3080 : Class II Primary Predicate Globus Sustain K130478 Medtronic Capstone K073291 Astura Medical Half Dome K163481 Additional Predicates ShurFit Precision Spine K0… | 2008 |
| * | K163481 | HALF DOME Posterior Lumbar Interbody SystemSummary page 4…FR 888.3080 : Class II Primary Predicate Globus Sustain K130478 Medtronic Capstone K073291 Astura Medical Half Dome K163481 Additional Predicates ShurFit Precision Spine K092193 Alphatec Spine IdentiTi K18… | 2017 |
| * | K092193 | Spinal Usa Interbody CagesSummary page 4…Medtronic Capstone K073291 Astura Medical Half Dome K163481 Additional Predicates ShurFit Precision Spine K092193 Alphatec Spine IdentiTi K183705 DeGen Medical Impulse System is a lumbar interbod… | 2009 |
| * | K183705 | IdentiTi Porous Ti Interbody SystemSummary page 4…Astura Medical Half Dome K163481 Additional Predicates ShurFit Precision Spine K092193 Alphatec Spine IdentiTi K183705 DeGen Medical Impulse System is a lumbar interbody fusion device for posterior an… | 2019 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210090 | Impulse AM Interbody Fusion System | 2021 | 7 |
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 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 46 of the 417 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210090 (Degen Medical, 2021) has gone furthest, with 7 descendants of its own.
- 11 other devices also cite its predicate K130478.
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 DeGen Medical Impulse implant is an intervertebral body fusion 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. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse System is indicated to be used with autograft and/or…
Read the full statement (116 words)
The DeGen Medical Impulse implant is an intervertebral body fusion 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. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse System is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201287: Impulse 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/K201287
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