# K133815: Intess Cervical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Direct, LLC
- Decided: Apr 16, 2014 after 121 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: 10 generations back to K841189 (1984). 31 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K110733: Daytona Anterior Cervical Cage, Spinenet, LLC (2011) 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

## Indications for use
The INTESSTM Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

Source page: https://510kreport.com/device/K133815
Methodology: https://510kreport.com/methodology