# K123100: Intess Lumbar Cage

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Direct, LLC
- Decided: Mar 28, 2013 after 177 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: 2 generations back to K071724 (2007). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 1.
- K081968: Modification to Lucent, Spinal Elements, Inc. (2008) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.

## Most influential descendants
- K182210: TiWAVE-L Porous Titanium Lumbar Cage (2019), 3 descendants of its own
- K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical (2023), 2 descendants of its own
- K252240: Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (2026), 0 descendants of its own
- K253583: LUX Expandable Lumbar Interbody System (2026), 0 descendants of its own
- K220902: Navagio Lumbar Cage (2022), 0 descendants of its own

## Indications for use
The INTESS Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from U2-Si. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INTESS Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The INTESS Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K123100
Methodology: https://510kreport.com/methodology