# 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

- Pathway: 510(k) (Traditional)
- Applicant: Icotec
- Decided: Jul 21, 2011 after 533 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: 8 generations back to K841189 (1984). 11 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K052533: Kimba Spinal Implant, Signus Medizintechnik GmbH (2005) Summary page 1.
- K080349: Kimba Mini, Signus Medizintechnik GmbH (2008) Summary page 1.

## Most influential descendants
- K172480: icotec Interbody Cage System (2018), 5 descendants of its own
- 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
- K133126: K7 Lumbar Spacers (2013), 1 descendant of its own

## Indications for use
The ETurn spinal implant is indicated for spinal fuision procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ETurn devices are to be used with autogenous bone graft. Patients should have had at least six (6) months of non-operative care prior to treatment with this device. The ETumn spinal implant is intended for use with supplemental fixation such as posterior fixation by pedicle screws and rods.

Source page: https://510kreport.com/device/K100305
Methodology: https://510kreport.com/methodology