510(k) · Cleared
ClearedGenesys Spine Apache® Anterior Lumbar Interbody Fusion 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 Nov 8, 2016 as substantially equivalent to K103034 (Genesys Spine, 2010) and 4 other predicates after a 168-day review. Its family tree reaches back 17 generations to 1984. 11 later devices descend from it.
- Decided
- Nov 8, 2016
- Review
- 168 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K841189 (1984). 118 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK121693 A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc. · 2012
- 2 generations backK133340 Spineworks Anterior Lumbar DeviceSpineworks, LLC · 2014
- 1 generation backK153123 Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016
- This deviceK161438 Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016
- Descendant · cites it directly · 9 of its ownK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- Descendant · 2 generations on · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- Descendant · 3 generations on · 3 of its ownK211417 F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022
- Descendant · 3 generations on · 2 of its ownK233594 Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023
- Descendant · 4 generations on · 1 of its ownK251735 Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 4 generations backK111166 A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC · 2011
- 3 generations backK121693 A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc. · 2012
- 2 generations backK133340 Spineworks Anterior Lumbar DeviceSpineworks, LLC · 2014
- 1 generation backK153123 Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016
- This deviceK161438 Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019 · cites it directly9descendants
- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · 2 generations on7descendants
- K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022 · 3 generations on3descendants
- K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023 · 3 generations on2descendants
- K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −4 | K111166 | A-Wedge Anterior Interbody System (a-Wedge a.I.S.) | Spineworks, LLC | 2011 | — |
| −3 | K121693 | A-Wedge Anterior Interbody System (a-Wedge Ais) | Sapphire Medical Group, Inc. | 2012 | — |
| −2 | K133340 | Spineworks Anterior Lumbar Device | Spineworks, LLC | 2014 | — |
| −1 | K153123 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | 2016 | — |
| 0 (this device) | K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | Genesys Spine | 2016 | — |
| +1 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| +2 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| +3 | K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 | — |
| +3 | K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | 2023 | — |
| +4 | K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025 | — |
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 | 10 | 0 |
| 2004 | 11 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 9 | 0 |
| 2008 | 18 | 0 |
| 2009 | 9 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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.
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? (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 |
|---|---|---|---|
| * | K103034 | Genesys Spine Interbody Fusion SystemSummary page 4…l: Orthopedic and Rehabilitation Devices Panel Primary Predicate: Genesys Spine Apache® Interbody Fusion System (K103034 / K153123) Additional Predicates: NuVasive® Brigade® and ACR Hyperlordotic System (K1125… | 2010 |
| * | K153123 | Genesys Spine Apache Interbody Fusion SystemSummary page 4…Orthopedic and Rehabilitation Devices Panel Primary Predicate: Genesys Spine Apache® Interbody Fusion System (K103034 / K153123) Additional Predicates: NuVasive® Brigade® and ACR Hyperlordotic System (K112561/K123045… | 2016 |
| * | K112561 | Nuvasive Coroent NO-Profile SystemSummary page 4…tem (K103034 / K153123) Additional Predicates: NuVasive® Brigade® and ACR Hyperlordotic System (K112561/K123045) DePuy Spine I/F Cage (P960025) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICA… | 2012 |
| * | K123045 | Brigade Standalone SystemSummary page 4…(K103034 / K153123) Additional Predicates: NuVasive® Brigade® and ACR Hyperlordotic System (K112561/K123045) DePuy Spine I/F Cage (P960025) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: Th… | 2013 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…dicates: NuVasive® Brigade® and ACR Hyperlordotic System (K112561/K123045) DePuy Spine I/F Cage (P960025) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The intent of this Special 510(k) is to add new components to the… | 1999 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 14 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 118 ancestors have a recall of any class.
- Of its descendants, K182987 (Genesys Spine, 2019) has gone furthest, with 9 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. 2016, 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 Apache® Anterior Lumbar Interbody Fusion 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 1 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161438: Genesys Spine Apache® Anterior Lumbar 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/K161438
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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