# K172480: icotec Interbody Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: May 17, 2018 after 274 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: 13 generations back to K003155 (2001). 111 ancestors in all.
5 later devices descend from it; 4 cite it directly.
1 of 117 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122588: Vusion CS Plus, Ortho Development Corp. (2013) Summary page 5.
- K080588: Scient'x Tribeca VBR, Scient'X USA, Inc. (2008) Summary page 5.
- K100305: Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and Eturn XX-12 K; Eturn XX-16 K Wher, Icotec (2011) Summary page 5.
- K111792: Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini, Signus Medizintechnik GmbH (2012) Summary page 5.
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 5.
- K093669: Sec Ibf Cage, Innvotec Surgical, Inc. (2010) Summary page 5.
- K112095: Acculif TL-Peek Ibf Cage, Coalign Innovations, Inc. (2011) Summary page 5.
- K111119: Trabecular Metal (TM) Fusion Device, Zimmer Spine, Inc. (2011) Summary page 5.

## Most influential descendants
- K193378: CarboClear Lumbar Cage System (2020), 2 descendants of its own
- K203683: CarboClear Lumbar Cage System (2021), 1 descendant of its own
- K192897: icotec Cervical Cage (2020), 1 descendant of its own
- K232792: icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) (2024), 0 descendants of its own
- K222874: CarboClear Cervical Cage System, CarboClear Cervical VBR System (2023), 0 descendants of its own

## Indications for use
The icotec Cervical Cage is intended for spinal fusion procedures at one level (C2-Tl) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. 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. The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autogratft. The icotec ETurn™ TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autogratft.

Source page: https://510kreport.com/device/K172480
Methodology: https://510kreport.com/methodology