# K181589: Curiteva Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Curiteva, LLC
- Decided: Dec 20, 2018 after 185 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: 19 generations back to K841189 (1984). 161 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081614: Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages, Interbody Innovations, Llp (2008) Summary page 4.
- K170395: Talos® Lumbar (HA) PEEK IBF Devices, Meditech Spine, LLC (2017) Summary page 4.
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif, Tyber Medical, LLC (2013) Summary page 4.
- K141953: Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL, Titan Spine, LLC (2014) Summary page 4.

## Most influential descendants
- K233744: Curiteva Porous PEEK Lumbar Interbody Fusion System (2024), 2 descendants of its own
- K250845: Curiteva Porous PEEK Standalone ALIF System (2025), 1 descendant of its own
- K212075: ShurFit Lumbar Interbody System (2021), 1 descendant of its own
- K252205: Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System (2026), 0 descendants of its own
- K231241: NanoHive Medical Lumbar Interbody System (2023), 0 descendants of its own

## Indications for use
The Curiteva Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 – S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non‐operative treatment prior to treatment with the device.

Source page: https://510kreport.com/device/K181589
Methodology: https://510kreport.com/methodology