# K251459: OneLIF™ Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Novapproach Spine, LLC
- Decided: Jun 12, 2025 after 31 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: 24 generations back to K841189 (1984). 405 ancestors in all.
No later device cites it as a predicate yet.
1 of 406 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211769: OneLIF Intervertebral Body Replacement System, Novapproach Spine (2021) Summary page 6.
- K222561: Align, Acuity Surgical Devices, LLC (2022) Summary page 6.

## Indications for use
The OneLIFT r Interbody Fusion System is an interbody fusion device system indicated for use in skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1), in patients with the following indications: degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, spinal deformity (degenerative scoliosis or kyphosis), spondylolisthesis or retrolisthesis, and failed previous fusion (pseudoarthrosis). Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. The OneLIFT r Interbody Fusion System is intended to be used with or without the screws which accompany the implants. These devices are intended for stand-alone use in patients with DDD or degenerative spondylolisthesis at one or two contiguous levels only when used with at least three screws per implant (including at least one screw in each endplate) and when 200 lordotic implants are used. When used at more than 2 contiguous levels, or for treatment of conditions other than DDD or degenerative spondylolisthesis, or with fewer than 3 accompanying screws, or when using implants greater than a 200 lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine. The implants can be placed via a variety of open or minimally invasive approaches. These include anterior and oblique approaches. The implant is designed for use with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.

Source page: https://510kreport.com/device/K251459
Methodology: https://510kreport.com/methodology