510(k) · Cleared
ClearedSpectrum Spine Lumbar Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 4, 2025 as substantially equivalent to K211258 (Medtronic Sofamor Danek USA, Inc., 2021) and 6 other predicates after a 189-day review. Its family tree reaches back 27 generations to 1984. 1 of the 609 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Apr 4, 2025
- Review
- 189 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 27 generations to K841189 (1984). 606 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 609 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations between
- 3 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 2 generations backK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK240838 Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc. · 2024
- This deviceK243074 Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252240 Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026
- Descendant · cites it directly · 0 of its ownK253377 Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025
Show all 27 generations
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 25 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 24 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 21 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 20 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 17 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 16 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 15 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 14 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 13 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 12 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 11 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 10 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 9 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 8 generations backK160955 Tritanium® PL CageStryker · 2016
- 7 generations backK162262 Tritanium® PL CageStryker · 2016
- 6 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 5 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 4 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 3 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 2 generations backK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK240838 Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc. · 2024
- This deviceK243074 Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −26 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −25 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −24 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −21 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −20 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −17 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −16 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −15 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −14 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −13 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −12 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −11 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −10 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −9 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −8 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −7 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −6 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −5 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −4 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −3 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −2 | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System… | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −1 | K240838 | Spectrum Spine Cervical Cage System | Spectrum Spine, Inc. | 2024 | — |
| 0 (this device) | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 | — |
| +1 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026 | — |
| +1 | K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2001 | 13 | 0 |
| 2002 | 12 | 0 |
| 2003 | 20 | 0 |
| 2004 | 30 | 0 |
| 2005 | 25 | 0 |
| 2006 | 18 | 0 |
| 2007 | 22 | 0 |
| 2008 | 54 | 1 |
| 2009 | 42 | 0 |
| 2010 | 31 | 0 |
| 2011 | 51 | 0 |
| 2012 | 37 | 0 |
| 2013 | 32 | 0 |
| 2014 | 45 | 0 |
| 2015 | 32 | 0 |
| 2016 | 30 | 0 |
| 2017 | 25 | 0 |
| 2018 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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.
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? (7)
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 |
|---|---|---|---|
| * | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Summary page 5…System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System – K211258 K243074… | 2021 |
| * | K230219 | Eminent Spine 3D Lumbar Interbody Fusion SystemsSummary page 6…Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System – K211258 Additional Predicates: Eminent Spine 3D Lumbar Interbody Fusion Systems – K230219 Spectrum Cervical Cage System – K240838 Anjon Bremer Molded Halo Crown – K193256 GSMedical Co, Ltd, AnyPlus T-PLIF PEEK Cages – K… | 2023 |
| * | K240838 | Spectrum Spine Cervical Cage SystemSummary page 6…ody System, Endoskeleton TT Interbody System – K211258 Additional Predicates: Eminent Spine 3D Lumbar Interbody Fusion Systems – K230219 Spectrum Cervical Cage System – K240838 Anjon Bremer Molded Halo Crown – K193256 GSMedical Co, Ltd, AnyPlus T-PLIF PEEK Cages – K131612 Spectrum Spine Expandable Titaniu… | 2024 |
| * | K193256 | Anjon Bremer Halo SystemSummary page 6…tem – K211258 Additional Predicates: Eminent Spine 3D Lumbar Interbody Fusion Systems – K230219 Spectrum Cervical Cage System – K240838 Anjon Bremer Molded Halo Crown – K193256 GSMedical Co, Ltd, AnyPlus T-PLIF PEEK Cages – K131612 Spectrum Spine Expandable Titanium PLIF/TLIF System – K201024; K173518 Th… | 2020 |
| * | K131612 | Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek CagesSummary page 6…Lumbar Interbody Fusion Systems – K230219 Spectrum Cervical Cage System – K240838 Anjon Bremer Molded Halo Crown – K193256 GSMedical Co, Ltd, AnyPlus T-PLIF PEEK Cages – K131612 Spectrum Spine Expandable Titanium PLIF/TLIF System – K201024; K173518 There are insignificant differences between the subject S… | 2014 |
| * | K201024 | Expandable Titanium PLIF/TLIF SystemSummary page 6…ge System – K240838 Anjon Bremer Molded Halo Crown – K193256 GSMedical Co, Ltd, AnyPlus T-PLIF PEEK Cages – K131612 Spectrum Spine Expandable Titanium PLIF/TLIF System – K201024; K173518 There are insignificant differences between the subject Spectrum Spine Lumbar Cage System and the predicates. The Indic… | 2021 |
| * | K173518 | Spectrum Spine Expandable Cages (SSEC)Summary page 6…– K240838 Anjon Bremer Molded Halo Crown – K193256 GSMedical Co, Ltd, AnyPlus T-PLIF PEEK Cages – K131612 Spectrum Spine Expandable Titanium PLIF/TLIF System – K201024; K173518 There are insignificant differences between the subject Spectrum Spine Lumbar Cage System and the predicates. The Indications fo… | 2019 |
What descends from it? (2)
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 16 companies; a new generation was cleared every 10 months on median.
- 69 of the 606 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K252240 (Spectrum Spine, 2026) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K211258.
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. 2025, 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 Spectrum Spine Lumbar Cage System devices with roughened surface textured features, are indicated for use in skeletally mature patients with lumbar degenerative disc disease (DOD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion, confirmed by imaging studies (radiographs, CT, MRI). DOD is defined as discogenic pain with degeneration of the disc. DOD patients may have up to Grade I…
Read the full statement (149 words)
The Spectrum Spine Lumbar Cage System devices with roughened surface textured features, are indicated for use in skeletally mature patients with lumbar degenerative disc disease (DOD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion, confirmed by imaging studies (radiographs, CT, MRI). DOD is defined as discogenic pain with degeneration of the disc. DOD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six months of nonoperative treatment. The Spectrum Spine Lumbar Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the lumbar spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243074: Spectrum Spine Lumbar Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243074
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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