# K230894: NuVasive Modulus ALIF System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jun 16, 2023 after 77 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: 26 generations back to K841189 (1984). 380 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 385 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193593: NuVasive 3DP Interfixated ALIF System, Nu Vasive, Incorporated (2020) Summary page 4.
- K210271: NuVasive Modulus ALIF System, Nu Vasive, Incorporated (2021) Summary page 4.
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 4.
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 4.

## Most influential descendants
- K240126: ProAM ALIF System (2024), 2 descendants of its own
- K253260: ORIO-3D Cage System (2026), 0 descendants of its own
- K251644: ProAM ALIF System (2025), 0 descendants of its own
- K242517: ProAM ACDF System (2024), 0 descendants of its own

## Indications for use
The NuVasive Modulus ALIF System is indicated for spinal fusion procedures in skeletally mature patients. These devices are intended to be used with bone screws, anchoring blades, or a combination of the two. When used with Modulus ALIF bone screws, the Modulus ALIF System 10o 200 lordotic cages may be used as a standalone system. When used with Modulus ALIF anchoring blades, the Modulus ALIF Interfixated System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared for use in the lumbar spine. When used with either the Modulus ALIF bone screws or the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated system 25o- 30' lordotic cages must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneic bone graft 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 devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Modulus ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (e.g., radiographs, CT scan, MRI scan). The Modulus ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolistheses and spinal stenosis at one or two adjacent levels, the Modulus ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by FDA for use in the lumbar spine in addition to the integrated screws/anchoring blades.

Source page: https://510kreport.com/device/K230894
Methodology: https://510kreport.com/methodology