510(k) · Cleared
Recalled · Class II · 2022EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages
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 11, 2017 as substantially equivalent to K122588 (Ortho Development Corp., 2013) and 5 other predicates after a 140-day review. Its family tree reaches back 15 generations to 1984. 1 of the 317 devices in its family, counting itself, has a Class I recall. 199 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 11, 2017
- Review
- 140 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 15 generations to K841189 (1984). 117 ancestors in all. 199 later devices descend from it, 16 citing it directly. 1 of the 317 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- This deviceK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017
- Descendant · cites it directly · 159 of its ownK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
- Descendant · 2 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
- Descendant · cites it directly · 131 of its ownK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
- Descendant · 2 generations on · 130 of its ownK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
- Descendant · 3 generations on · 75 of its ownK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 7 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 6 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 5 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 4 generations backK103169 AleuttianK2m, Inc. · 2011
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- This deviceK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017
Showing 5 of 199 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 5 of 199 · See all- K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · cites it directly159descendants
- K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 2 generations on141descendants
- K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019 · cites it directly131descendants
- K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2020 · 2 generations on130descendants
- K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc. · 2021 · 3 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −7 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −6 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −5 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −4 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −3 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −2 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −1 | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4Web, Inc. | 2015 | — |
| 0 (this device) | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | — |
| +1 | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | — |
| +2 | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018 | — |
| +1 | K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Eit Emerging Implant Technologies GmbH | 2019 | — |
| +2 | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT… | Eit Emerging Implant Technologies GmbH | 2020 | — |
| +3 | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System… | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
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 | 11 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 13 | 1 |
| 2009 | 8 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 7 | 0 |
| 2020 | 11 | 0 |
| 2021 | 12 | 0 |
| 2022 | 24 | 0 |
| 2023 | 30 | 0 |
| 2024 | 35 | 0 |
| 2025 | 39 | 0 |
| 2026 | 34 | 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? (6)
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 |
|---|---|---|---|
| * | K122588 | Vusion CS PlusSummary page 7…Manufacturer Device Name K-Number Ortho Vusion CS+ K122588 Development Additional Predicates: Scient’X Tribeca Cage (K080588) CoAlign AccuLIF (K09… | 2013 |
| * | K080588 | Scient'x Tribeca VBRSummary page 7…Ortho Vusion CS+ K122588 Development Additional Predicates: Scient’X Tribeca Cage (K080588) CoAlign AccuLIF (K093669, K112095) 4Web PLIF STS, TLIF STS and OLIF STS (Spine T… | 2008 |
| * | K093669 | Sec Ibf CageSummary page 7…Vusion CS+ K122588 Development Additional Predicates: Scient’X Tribeca Cage (K080588) CoAlign AccuLIF (K093669, K112095) 4Web PLIF STS, TLIF STS and OLIF STS (Spine Truss System) (K143258)… | 2010 |
| * | K112095 | Acculif TL-Peek Ibf CageSummary page 7…usion CS+ K122588 Development Additional Predicates: Scient’X Tribeca Cage (K080588) CoAlign AccuLIF (K093669, K112095) 4Web PLIF STS, TLIF STS and OLIF STS (Spine Truss System) (K143258)… | 2011 |
| * | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)Summary page 7…588) CoAlign AccuLIF (K093669, K112095) 4Web PLIF STS, TLIF STS and OLIF STS (Spine Truss System) (K143258) Precision Spine ShurFit® PLIF Interbody Cage (K092193) Performance Testing Summary: The worst case devi… | 2015 |
| * | K092193 | Spinal Usa Interbody CagesSummary page 7…4Web PLIF STS, TLIF STS and OLIF STS (Spine Truss System) (K143258) Precision Spine ShurFit® PLIF Interbody Cage (K092193) Performance Testing Summary: The worst case devices were subjected to mechanical testing. Testing included static compression,… | 2009 |
What descends from it? (199)
See all 19916 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular… | 2017 | 159 |
| K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | 2019 | 131 |
| K181347 | Aries® Lumbar Interbodies | 2018 | 24 |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX… | 2018 | 12 |
| K200429 | BEE Cages | 2021 | 11 |
| K182987 | Genesys Spine 3DP Lumbar Interbody System | 2019 | 9 |
| K191489 | Genesys Spine 3DP Cervical Interbody System | 2020 | 7 |
| K200312 | Tryptik Ti | 2020 | 2 |
| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | 2025 | 1 |
| K211413 | BEE PLIF Cage | 2021 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2022 | Class II | Z-1323-2022 | Labeling Change Control | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton |
| May 20, 2022 | Class II | Z-1324-2022 | Labeling Change Control | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton |
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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 117 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172888 (Eit Emerging Implant Technologies GmbH, 2017) has gone furthest, with 159 descendants of its own.
- 1 other device also cites its predicate K122588.
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. 2017, 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 EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative…
Read the full statement (448 words)
The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
The EIT Cellular Titanium® PLIF Cages in combination 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 interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history 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.
The EIT Cellular Titanium® TLIF Cages in combination 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 interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history 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.
The EIT Cellular Titanium® ALIF Cages in combination 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 interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170503 · printed Nov 3, 2026
Cite this page
510(k) Report. “K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K170503
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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