510(k) · Cleared
ClearedGenesys Spine 3DP Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesys Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 12, 2019 as substantially equivalent to K103034 (Genesys Spine, 2010) and 5 other predicates after a 409-day review. Its family tree reaches back 23 generations to 1984. 1 of the 353 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Dec 12, 2019
- Review
- 409 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 23 generations to K841189 (1984). 343 ancestors in all, the oldest K792352 (1979). 9 later devices descend from it, 2 citing it directly. 1 of the 353 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 2 generations backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- 1 generation backK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
- This deviceK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- Descendant · cites it directly · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- Descendant · 2 generations on · 3 of its ownK211417 F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK233594 Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023
- Descendant · 3 generations on · 1 of its ownK251735 Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK261882 Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 5 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 4 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 3 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 2 generations backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- 1 generation backK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
- This deviceK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 9 · See all- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · cites it directly7descendants
- K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022 · 2 generations on3descendants
- K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023 · 2 generations on2descendants
- K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025 · 3 generations on1descendant
- K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −5 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −4 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −3 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −2 | K172009 | Cascadia Interbody System | K2m, Inc. | 2017 | 3 |
| −1 | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
| 0 (this device) | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| +1 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| +2 | K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 | — |
| +2 | K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | 2023 | — |
| +3 | K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025 | — |
| +3 | K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 18 | 0 |
| 2004 | 28 | 0 |
| 2005 | 21 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 48 | 1 |
| 2009 | 28 | 0 |
| 2010 | 17 | 0 |
| 2011 | 27 | 0 |
| 2012 | 14 | 0 |
| 2013 | 18 | 0 |
| 2014 | 14 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K103034 | Genesys Spine Interbody Fusion SystemSummary page 4…Orthopedic Devices Panel Legally Marketed Primary Predicate: Apache Interbody Fusion System (unmodified) devices to (Genesys Spine - K103034) Which Substantial Additional Predicates: Equivalence is Claimed: Aries® Lumbar Interbodies (Osseus Fus… | 2010 |
| * | K181347 | Aries® Lumbar InterbodiesSummary page 4…bstantial Additional Predicates: Equivalence is Claimed: Aries® Lumbar Interbodies (Osseus Fusion Systems, LLC – K181347) EIT Cellular Titanium® Cervical & Lumbar Cages (Emerging Imp… | 2018 |
| * | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Summary page 4…– K181347) EIT Cellular Titanium® Cervical & Lumbar Cages (Emerging Implant Technologies – K170503), Apache Lateral Lumbar System (Genesys Spine – K161404),… | 2017 |
| * | K161404 | Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemSummary page 4…(Emerging Implant Technologies – K170503), Apache Lateral Lumbar System (Genesys Spine – K161404), Apache Hyperlordotic ALIF System (Genesys Spine – K161438),… | 2016 |
| * | K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemSummary page 4…Spine – K161404), Apache Hyperlordotic ALIF System (Genesys Spine – K161438), and the Apache Lumbar PEEK Interbodies (Genesys Spine - K15… | 2016 |
| * | K153123 | Genesys Spine Apache Interbody Fusion SystemSummary page 4…– K161438), and the Apache Lumbar PEEK Interbodies (Genesys Spine - K153123) DEVICE DESCRIPTION: The Genesys Spine 3DP Lumbar Interbody System is comprised of additively manufactured lumbar intervertebral… | 2016 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 16 companies; a new generation was cleared every 9 months on median.
- 45 of the 343 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191489 (Genesys Spine, 2020) has gone furthest, with 7 descendants of its own.
- 21 other devices also cite its predicate K103034.
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. 2019, 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 Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.
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/K182987 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182987: Genesys Spine 3DP Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182987
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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