# K250845: Curiteva Porous PEEK Standalone ALIF System

- Pathway: 510(k) (Traditional)
- Applicant: Curiteva, Inc.
- Decided: Jun 18, 2025 after 90 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 30 generations back to K841189 (1984). 1,069 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 1,071 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160597: INDEPENDENCE MIS Spacers, Globus Medical, Inc. (2016) Summary page 5.
- K213935: PISCES-SA Standalone ALIF Interbody System, Osseus Fusion Systems (2022) Summary page 5.
- K233744: Curiteva Porous PEEK Lumbar Interbody Fusion System, Curiteva, Inc. (2024) Summary page 5.

## Most influential descendants
- 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
Curiteva Porous PEEK Standalone ALIF System The Curiteva Porous PEEK Standalone ALIF devices are intended for use in patients with degenerative disc disease (ODD) at one or two contiguous levels of the lumbosacral spine (L2-S1). ODD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The system spacers 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. The Curiteva Porous PEEK Standalone ALIF spacer is an interbody fusion device to be used with three titanium alloy screws or anchors. When used with screws, the system is a standalone interbody fusion device. When used with anchors, the system is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>20 ° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Curiteva Porous PEEK ALIF System (Without Integrated Fixation) The Curiteva Porous PEEK ALIF devices are intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (ODD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DOD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The system spacers 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. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20 ° lordosis) must be used with at least anterior supplemental fixation.

Source page: https://510kreport.com/device/K250845
Methodology: https://510kreport.com/methodology