510(k) · Cleared
Recalled · 2011Genesys Spine 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 Dec 10, 2010 as substantially equivalent to P950019 (Stryker Spine, 1996) and 7 other predicates after a 58-day review. Its family tree reaches back 10 generations to 1984. 137 later devices descend from it. It has been recalled once.
- Decided
- Dec 10, 2010
- Review
- 58 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 8
Its longest line of descent runs back 10 generations to K841189 (1984). 35 ancestors in all. 137 later devices descend from it, 22 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK103034 Genesys Spine Interbody Fusion SystemGenesys Spine · 2010
- Descendant · cites it directly · 25 of its ownK120966 Depuy Pulse Lumbar Cage SystemMedos International SARL · 2012
- Descendant · cites it directly · 23 of its ownK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- Descendant · 2 generations on · 22 of its ownK131671 MectalifMedacta International · 2013
- Descendant · cites it directly · 20 of its ownK111820 Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012
- Descendant · cites it directly · 18 of its ownK180056 Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine · 2018
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK103034 Genesys Spine Interbody Fusion SystemGenesys Spine · 2010
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 137 · See all- K120966Depuy Pulse Lumbar Cage SystemMedos International SARL · 2012 · cites it directly25descendants
- K120024Mectalif TransforaminalMedacta International S.A. · 2012 · cites it directly23descendants
- K131671MectalifMedacta International · 2013 · 2 generations on22descendants
- K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012 · cites it directly20descendants
- K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine · 2018 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −4 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −3 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −2 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −1 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| 0 (this device) | K103034 | Genesys Spine Interbody Fusion System | Genesys Spine | 2010 | — |
| +1 | K120966 | Depuy Pulse Lumbar Cage System | Medos International SARL | 2012 | — |
| +1 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| +2 | K131671 | Mectalif | Medacta International | 2013 | — |
| +1 | K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | Bm Korea Co., Ltd. | 2012 | — |
| +1 | K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System | Genesys Spine | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 10 | 0 |
| 2021 | 9 | 0 |
| 2022 | 13 | 0 |
| 2023 | 17 | 0 |
| 2024 | 13 | 0 |
| 2025 | 11 | 0 |
| 2026 | 13 | 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? (8)
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 |
|---|---|---|---|
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 1…edicate devices include various cleared interbody fusion and VBR systems: - RAY® Threaded Fusion Cage (P950019) - Lumbar I/F Cage (P960025) - InterFix (P97001 5)… | 1996 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…and VBR systems: - RAY® Threaded Fusion Cage (P950019) - Lumbar I/F Cage (P960025) - InterFix (P97001 5) - BAKIC (P980048)… | 1999 |
| * | P970015 | Inter Fix Threaded Fusion DeviceSummary page 1…- RAY® Threaded Fusion Cage (P950019) - Lumbar I/F Cage (P960025) - InterFix (P97001 5) - BAKIC (P980048) - Affinity Cage System (P000028)… | 1999 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…P950019) - Lumbar I/F Cage (P960025) - InterFix (P97001 5) - BAKIC (P980048) - Affinity Cage System (P000028) - MC+ (K043479, K091088)… | 2001 |
| * | P000028 | Affinity (TM) Cage SystemSummary page 1…25) - InterFix (P97001 5) - BAKIC (P980048) - Affinity Cage System (P000028) - MC+ (K043479, K091088) - Eminent Spine System (K090064) =… | 2002 |
| * | K043479 | MC+ Partial VBRSummary page 1…P97001 5) - BAKIC (P980048) - Affinity Cage System (P000028) - MC+ (K043479, K091088) - Eminent Spine System (K090064)… | 2005 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 1…- BAKIC (P980048) - Affinity Cage System (P000028) - MC+ (K043479, K091088) - Eminent Spine System (K090064)… | 2009 |
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 1…- Affinity Cage System (P000028) - MC+ (K043479, K091088) - Eminent Spine System (K090064) hib3o34 %~e2… | 2009 |
What descends from it? (137)
See all 13722 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120966 | Depuy Pulse Lumbar Cage System | 2012 | 25 |
| K120024 | Mectalif Transforaminal | 2012 | 23 |
| K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | 2012 | 20 |
| K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System | 2018 | 18 |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | 2018 | 17 |
| K130913 | Genesys Spine Apache Lateral Lumbar Interbody Fusion System | 2013 | 14 |
| K153123 | Genesys Spine Apache Interbody Fusion System | 2016 | 12 |
| K150812 | Genesys Spine Apache Cervical Interbody Fusion System | 2015 | 12 |
| K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | 2016 | 11 |
| K161404 | Genesys Spine Apache® Lateral Lumbar Interbody Fusion System | 2016 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2011 | Not classified | Z-1698-2012 | Reprocessing Controls | The inserters have the potential to break. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 35 ancestors have a recall of any class.
- Of its descendants, K120966 (Medos International SARL, 2012) has gone furthest, with 25 descendants of its own.
- 37 other devices also cite its predicate P950019.
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. 2010, 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?
When used as a cervical intervertebral body fusion device, the Genesys Spine Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine with accompanying radicular symptoms at one disc level from the 02-03 disc to the 07-TI disc. DD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is…
Read the full statement (312 words)
When used as a cervical intervertebral body fusion device, the Genesys Spine Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine with accompanying radicular symptoms at one disc level from the 02-03 disc to the 07-TI disc. DD is defined as discogenic pain 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. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
When used as a lumbar intervertebral body fusion device, the Genesys Spine Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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 (ODD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DOD 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.
When used as a vertebral body replacement device, the Genesys Spine System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine (from Ti to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomnechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device system is intended to be used with autograft or allograft bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103034: Genesys Spine 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/K103034
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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