510(k) · Cleared
ClearedExpandable Titanium PLIF/TLIF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 29, 2021 as substantially equivalent to K172696 (Orthofix, Inc., 2018) and 3 other predicates after a 374-day review. Its family tree reaches back 20 generations to 1984. 1 of the 165 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Apr 29, 2021
- Review
- 374 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 20 generations to K841189 (1984). 159 ancestors in all. 5 later devices descend from it, 3 citing it directly. 1 of the 165 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 2 generations backK162918 Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017
- 1 generation backK172696 FORZA® XP Expandable Spacer SystemOrthofix, Inc. · 2018
- This deviceK201024 Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC · 2021
- Descendant · cites it directly · 2 of its ownK243074 Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK212075 ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021
- Descendant · 2 generations on · 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
- Descendant · 2 generations on · 0 of its ownK221172 FOCUS Interbody SystemOc Medical Devices · 2022
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 10 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 9 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 8 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 7 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 6 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 5 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 4 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 2 generations backK162918 Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017
- 1 generation backK172696 FORZA® XP Expandable Spacer SystemOrthofix, Inc. · 2018
- This deviceK201024 Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC · 2021
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025 · cites it directly2descendants
- K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021 · cites it directly1descendant
- K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026 · 2 generations on0descendants
- K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025 · cites it directly0descendants
- K221172FOCUS Interbody SystemOc Medical Devices · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −10 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −9 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −8 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −7 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −6 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −5 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −4 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −3 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −2 | K162918 | Atlas Spine Expandable Interbody System | Atlas Spine, Inc. | 2017 | — |
| −1 | K172696 | FORZA® XP Expandable Spacer System | Orthofix, Inc. | 2018 | — |
| 0 (this device) | K201024 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, LLC | 2021 | — |
| +1 | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 | — |
| +1 | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | — |
| +2 | 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 | — |
| +2 | K221172 | FOCUS Interbody System | Oc Medical Devices | 2022 | — |
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 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 12 | 0 |
| 2006 | 4 | 0 |
| 2007 | 10 | 0 |
| 2008 | 21 | 1 |
| 2009 | 10 | 0 |
| 2010 | 11 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K172696 | FORZA® XP Expandable Spacer SystemSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K172696 FORZA@ XP Expandable Orthofix Inc. Primary Spacer System… | 2018 |
| * | K080537 | L-VarlockSummary page 5…Type K172696 FORZA@ XP Expandable Orthofix Inc. Primary Spacer System K080537 L-Varlock Lumbar Cage Kiscomedica Additional K173518 Spectrum Spi… | 2008 |
| * | K173518 | Spectrum Spine Expandable Cages (SSEC)Summary page 5…fix Inc. Primary Spacer System K080537 L-Varlock Lumbar Cage Kiscomedica Additional K173518 Spectrum Spine Expandable Spectrum Spine, LLC Additional Cages K1404… | 2019 |
| * | K140411 | Altera SpacerSummary page 5…Kiscomedica Additional K173518 Spectrum Spine Expandable Spectrum Spine, LLC Additional Cages K140411 ALTERATM Spacer Globus Medical, Inc. Additional PERFORMANCE DATA The Expandable Titanium… | 2014 |
What descends from it? (5)
3 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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 16 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 159 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243074 (Spectrum Spine, Inc., 2025) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K172696.
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. 2021, 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 Expandable PLIF/TLIF Interbody Cage System is an interbody fusion device intended for use in patients with degenerative disc disease (DOD) at one or two contiguous levels of the lumbosacral spine (L2-S1 ). DOD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In…
Read the full statement (109 words)
The Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an interbody
fusion device intended for use in patients with degenerative disc disease (DOD) at
one or two contiguous levels of the lumbosacral spine (L2-S1 ). DOD is defined as
discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies. These patients should be skeletally mature and have had at
least six (6) months of non-operative treatment. In addition, these patients may have
up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Expandable
PLIF/TLIF implants are to be filled with autogenous bone graft material. The device
are intended to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201024: Expandable Titanium PLIF/TLIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201024
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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