510(k) · Cleared
ClearedGAIA Lumbar Interbody Fusion Device (LIFD) Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Printerprezz · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 8, 2020 as substantially equivalent to K170676 (Hd Lifesciences, LLC, 2017) and 7 other predicates after an 87-day review. Its family tree reaches back 21 generations to 1984. 1 of the 304 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 8, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 21 generations to K841189 (1984). 303 ancestors in all. No later device cites it as a predicate yet. 1 of the 304 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 2 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 1 generation backK172816 TiGer Shark™ SystemChoicespine, LP · 2018
- This deviceK201939 GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz · 2020
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 11 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 10 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 9 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 8 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 7 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 6 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 5 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 4 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 3 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 2 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 1 generation backK172816 TiGer Shark™ SystemChoicespine, LP · 2018
- This deviceK201939 GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz · 2020
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −11 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −10 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −9 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −8 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −7 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −6 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −5 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −4 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −3 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| −2 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| −1 | K172816 | TiGer Shark™ System | Choicespine, LP | 2018 | — |
| 0 (this device) | K201939 | GAIA Lumbar Interbody Fusion Device (LIFD) Family | Printerprezz | 2020 | — |
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 | 12 | 0 |
| 2003 | 18 | 0 |
| 2004 | 22 | 0 |
| 2005 | 22 | 0 |
| 2006 | 9 | 0 |
| 2007 | 16 | 0 |
| 2008 | 39 | 1 |
| 2009 | 28 | 0 |
| 2010 | 18 | 0 |
| 2011 | 23 | 0 |
| 2012 | 13 | 0 |
| 2013 | 16 | 0 |
| 2014 | 15 | 0 |
| 2015 | 8 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K170676 | HD Lumbar Interbody SystemSummary page 6…Trade or Proprietary or Model Manufacturer Predicate Name Type K170676 HD Lumbar Interbody System HD LifeSciences LLC Primary K172816 TiGer Shark™… | 2017 |
| * | K172816 | TiGer Shark™ SystemSummary page 6…Name Type K170676 HD Lumbar Interbody System HD LifeSciences LLC Primary K172816 TiGer Shark™ System Choice Spine, LP Additional K162496 Foundation… | 2018 |
| * | K162496 | Foundation 3D InterbodySummary page 6…HD Lumbar Interbody System HD LifeSciences LLC Primary K172816 TiGer Shark™ System Choice Spine, LP Additional K162496 Foundation F3 Interbody CoreLink, LLC Additional K143258 PLIF STS,… | 2017 |
| * | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)Summary page 6…TiGer Shark™ System Choice Spine, LP Additional K162496 Foundation F3 Interbody CoreLink, LLC Additional K143258 PLIF STS, TLIF STS, and OLIF 4WEB, Inc. Additional STS K1805… | 2015 |
| * | K180556 | Corelink Foundation 3D Anterior Lumbar SystemSummary page 6…CoreLink, LLC Additional K143258 PLIF STS, TLIF STS, and OLIF 4WEB, Inc. Additional STS K180556 Foundation 3D Anterior Lumbar CoreLink, LLC Additional System K1… | 2018 |
| * | K190483 | SPIRA Open Matrix ALIF and LLIFSummary page 6…STS K180556 Foundation 3D Anterior Lumbar CoreLink, LLC Additional System K190483 SPIRA Open Matrix ALIF and Camber Spine Additional LLIF… | 2019 |
| * | K111354 | GS Medical Anyplus Peek Lumbar Cages (Alif and Dlif)Summary page 6…0483 SPIRA Open Matrix ALIF and Camber Spine Additional LLIF Technologies K111354/K131612 AnyPlus® PEEK Lumbar Fusion GS Medical Co, Ltd. Additional Cage Pri… | 2011 |
| * | K131612 | Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek CagesSummary page 6…SPIRA Open Matrix ALIF and Camber Spine Additional LLIF Technologies K111354/K131612 AnyPlus® PEEK Lumbar Fusion GS Medical Co, Ltd. Additional Cage PrinterPrez… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 17 companies; a new generation was cleared every 9 months on median.
- 34 of the 303 ancestors have a recall of any class; 1 has a Class I recall.
- 6 other devices also cite its predicate K170676.
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. 2020, 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 ASTRAEUS anterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1…
Read the full statement (510 words)
The ASTRAEUS anterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The ASTRAEUS ALIF cage is to be implanted via an anterior approach.
The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The PROMETHEUS PLIF cage is to be implanted via a posterior approach.
The THEMIS Transforaminal posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the THEMIS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201939: GAIA Lumbar Interbody Fusion Device (LIFD) Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201939
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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