# 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

- Pathway: 510(k) (Special)
- Applicant: Eit Emerging Implant Technologies GmbH
- Decided: Jul 15, 2020 after 30 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K841189 (1984). 212 ancestors in all.
130 later devices descend from it; 18 cite it directly.
1 of 343 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 5.
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF, Eit Emerging Implant Technologies GmbH (2018) Summary page 5.
- K183447: EIT Cellular Titanium Lumbar Cage - T/PLIF, Eit Emerging Implant Technologies GmbH (2019) Summary page 5.

## Most influential descendants
- K211258: Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System (2021), 75 descendants of its own
- K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2021), 55 descendants of its own
- K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2022), 49 descendants of its own
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty (2022), 29 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K201605
Methodology: https://510kreport.com/methodology