# K192897: icotec Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Mar 20, 2020 after 161 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 21 generations back to K841189 (1984). 341 ancestors in all.
1 later device descends from it; 1 cites 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)
- K172480: icotec Interbody Cage System, Icotec AG (2018) Summary page 5.
- K182284: Tyber Medical PT Interbody Spacer, Tyber Medical, LLC (2019) Summary page 5.

## Most influential descendants
- K232792: icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) (2024), 0 descendants of its own

## Indications for use
The icotec Cervical Cage is intended for spinal fusion procedures at one or more levels (C2-Tl) in skeletally mature patients with degenerative cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K192897
Methodology: https://510kreport.com/methodology