510(k) · Cleared
ClearedEIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eit Emerging Implant Technologies GmbH · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 15, 2020 as substantially equivalent to K172888 (Eit Emerging Implant Technologies GmbH, 2017) and 2 other predicates after a 30-day review. Its family tree reaches back 22 generations to 1984. 1 of the 343 devices in its family, counting itself, has a Class I recall. 130 later devices descend from it.
- Decided
- Jul 15, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K841189 (1984). 212 ancestors in all. 130 later devices descend from it, 18 citing it directly. 1 of the 343 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK160955 Tritanium® PL CageStryker · 2016
- 2 generations backK181014 Tritanium PL CageStryker Spine · 2018
- 1 generation backK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
- This deviceK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
- Descendant · cites it directly · 75 of its ownK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
- Descendant · 2 generations on · 55 of its ownK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · 2 generations on · 49 of its ownK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- Descendant · cites it directly · 29 of its ownK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- Descendant · 3 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 3 generations backK160955 Tritanium® PL CageStryker · 2016
- 2 generations backK181014 Tritanium PL CageStryker Spine · 2018
- 1 generation backK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
- This deviceK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 130 · See all- K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc. · 2021 · cites it directly75descendants
- K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021 · 2 generations on55descendants
- K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022 · 2 generations on49descendants
- K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022 · cites it directly29descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −4 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −3 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −2 | K181014 | Tritanium PL Cage | Stryker Spine | 2018 | — |
| −1 | K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Eit Emerging Implant Technologies GmbH | 2019 | — |
| 0 (this device) | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT… | Eit Emerging Implant Technologies GmbH | 2020 | — |
| +1 | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System… | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +2 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +2 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| +1 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| +3 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 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 | 15 | 0 |
| 2004 | 21 | 0 |
| 2005 | 17 | 0 |
| 2006 | 4 | 0 |
| 2007 | 10 | 0 |
| 2008 | 31 | 1 |
| 2009 | 20 | 0 |
| 2010 | 9 | 0 |
| 2011 | 15 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 9 | 0 |
| 2022 | 15 | 0 |
| 2023 | 19 | 0 |
| 2024 | 27 | 0 |
| 2025 | 30 | 0 |
| 2026 | 29 | 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? (3)
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 |
|---|---|---|---|
| * | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Summary page 5…MAX - Intervertebral Fusion Device with Bone Graft, Lumbar D. Predicate Device Names EIT Cellular Titanium® Cervical Cage (K172888) EIT Cellular Titanium® ALIF Cage (K172888) EIT Cellular Titanium® TLIF C… | 2017 |
| * | K181644 | EIT Cellular Titanium® Lumbar Cage LLIFSummary page 5…llular Titanium® ALIF Cage (K172888) EIT Cellular Titanium® TLIF Cage (K172888) EIT Cellular Titanium® LLIF Cage (K181644) EIT Cellular Titanium® T/PLIF Cage (K183447)… | 2018 |
| * | K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIFSummary page 5…ular Titanium® TLIF Cage (K172888) EIT Cellular Titanium® LLIF Cage (K181644) EIT Cellular Titanium® T/PLIF Cage (K183447) K201605… | 2019 |
What descends from it? (130)
See all 13018 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA… | 2021 | 75 |
| K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | 2022 | 29 |
| K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu… | 2020 | 18 |
| K210728 | CONDUIT Instruments | 2021 | 5 |
| K212823 | DePuy CONDUIT LLIF Angled Inserters | 2021 | 3 |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT… | 2023 | 2 |
| K213791 | Unispace SA Cervical Cage | 2022 | 2 |
| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | 2025 | 1 |
| K230872 | Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction… | 2023 | 1 |
| K221325 | CONDUIT Lateral Switch Plate | 2022 | 1 |
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 · 4 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 14 companies; a new generation was cleared every 10 months on median.
- 25 of the 212 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K211258 (Medtronic Sofamor Danek USA, Inc., 2021) has gone furthest, with 75 descendants of its own.
- 12 other devices also cite its predicate K172888.
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?
EIT Cellular Titanium® Cervical Cage The EIT Cellular Titanmum® Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices mtended for use for anterior cervical mterbody fusion m skeletally mature patients with cervical disc degeneration and/or cervical spinal mstabihity, as confirmed by maging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at…
Read the full statement (589 words)
EIT Cellular Titanium® Cervical Cage
The EIT Cellular Titanmum® Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices mtended for use for anterior cervical mterbody fusion m skeletally mature patients with cervical disc degeneration and/or cervical spinal mstabihity, as confirmed by maging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The EIT Cellular Titanmum Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. EIT Cellular Titanium Cervical Cages are designed for use with autogenous and/or allogeneic bone graft compnised of cancellous, and/or corticocancellous bone graft to facilitate fusion.
EIT Cellular Titanium® ALIF Cage
The EIT Cellular Titanmum® ALIF Cages with a microscopic roughened surface and micro and nano-scale features m combimation with supplemental fixation are indicated for use with autogenous bone graft m patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 — S1 whose condition requires the use of mterbody and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
EIT Cellular Titanium® TLIF Cage
The EIT Cellular Titanmum® TLIF Cages with a microscopic roughened surface and micro and nano-scale features m combimation with supplemental fixation are indicated for use with autogenous bone graft m patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 — S1 whose condition requires the use of mterbody and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
EIT Cellular Titanium® LLIF Cage
The EIT Cellular Titanmum® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for mtervertebral body fusion procedures m skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L.2-S1. DDD 1s 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). These spinal mplants are to be used with autogenous bone graft and/or allogeneic bone graft compnised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
EIT Cellular Titanium® T/PLIF Cage
The EIT Cellular Titanmum® T/PLIF Cages with a microscopic roughened surface and micro and nano-scale features m combimation with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 — S1 whose condition requires the use of mterbody and radiographic studies. These DDD patients may have up to Grade I spondylohisthesis or retrolisthesis at the mvolved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201605
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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