510(k) · Cleared
ClearedEIT Cellular Titanium® Lumbar Cage LLIF
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 Oct 12, 2018 as substantially equivalent to K161888 (Spineart, 2016) and 1 other predicate after a 112-day review. Its family tree reaches back 17 generations to 1984. 1 of the 313 devices in its family, counting itself, has a Class I recall. 141 later devices descend from it.
- Decided
- Oct 12, 2018
- Review
- 112 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K841189 (1984). 171 ancestors in all. 141 later devices descend from it, 6 citing it directly. 1 of the 313 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- 2 generations backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- 1 generation backK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
- This deviceK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
- Descendant · cites it directly · 130 of its ownK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
- Descendant · 2 generations on · 75 of its ownK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
- Descendant · 3 generations on · 55 of its ownK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · 3 generations on · 49 of its ownK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- Descendant · 2 generations on · 29 of its ownK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 9 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 8 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 7 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 6 generations backK103169 AleuttianK2m, Inc. · 2011
- 5 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 4 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 3 generations backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- 2 generations backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- 1 generation backK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
- This deviceK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
Showing 5 of 141 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 141 · See all- K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2020 · cites it directly130descendants
- K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc. · 2021 · 2 generations on75descendants
- K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021 · 3 generations on55descendants
- K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022 · 3 generations on49descendants
- K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −9 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −8 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −7 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −6 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −5 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −4 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −3 | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4Web, Inc. | 2015 | — |
| −2 | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | 2 |
| −1 | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | — |
| 0 (this device) | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018 | — |
| +1 | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT… | Eit Emerging Implant Technologies GmbH | 2020 | — |
| +2 | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System… | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +3 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +3 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| +2 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy 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 | 16 | 0 |
| 2005 | 13 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 25 | 1 |
| 2009 | 15 | 0 |
| 2010 | 6 | 0 |
| 2011 | 13 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 17 | 0 |
| 2023 | 22 | 0 |
| 2024 | 29 | 0 |
| 2025 | 31 | 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? (2)
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 |
|---|---|---|---|
| * | K161888 | JULIET® LL Lateral Lumbar CageSummary page 5…icate Devices Manufacturer Device Name K-Number SPINEART JULIET® LL Lateral Lumbar Cage K161888 Additional Predicate Devices: The EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, and EIT Cellular Titaniu… | 2016 |
| * | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Summary page 5…icate Devices: The EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, and EIT Cellular Titanium® ALIF Cages (EIT Emerging Implant Technologies, GmbH) (K172888) are substantially equivalent to the subject device with respect to indications, design, additive manufacturing process, and perf… | 2017 |
What descends from it? (141)
See all 1416 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular… | 2020 | 130 |
| K191906 | MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed… | 2020 | 6 |
| K201453 | Fortilink Cages with TiPlus Technology | 2020 | 4 |
| K223868 | PYXIS 3D Titanium Cage System | 2023 | 2 |
| K221325 | CONDUIT Lateral Switch Plate | 2022 | 1 |
| K223688 | CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments | 2023 | 0 |
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 34 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 20 of the 171 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201605 (Eit Emerging Implant Technologies GmbH, 2020) has gone furthest, with 130 descendants of its own.
- 1 other device also cites its predicate K161888.
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. 2018, 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® Lumbar Cage LLIF is indicated for intervertebral body fusion procedures 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). These spinal…
Read the full statement (116 words)
EIT Cellular Titanium® Lumbar Cage LLIF is indicated for intervertebral body fusion procedures 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). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181644 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181644: EIT Cellular Titanium® Lumbar Cage LLIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181644
Report an extraction error
Are you the manufacturer?
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