# K233744: Curiteva Porous PEEK Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Curiteva, Inc.
- Decided: Jan 18, 2024 after 57 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: 20 generations back to K841189 (1984). 162 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181589: Curiteva Lumbar Interbody Fusion System, Curiteva, LLC (2018) Summary page 4.

## Most influential descendants
- K250845: Curiteva Porous PEEK Standalone ALIF System (2025), 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

## Indications for use
The Curiteva Porous PEEK 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) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion 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/K233744
Methodology: https://510kreport.com/methodology