# K210271: NuVasive Modulus ALIF System

- Pathway: 510(k) (Special)
- Applicant: Nu Vasive, Incorporated
- Decided: Mar 1, 2021 after 28 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: 25 generations back to K841189 (1984). 294 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 300 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203201: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System, Nu Vasive, Incorporated (2021) Summary page 4.
- K193593: NuVasive 3DP Interfixated ALIF System, Nu Vasive, Incorporated (2020) Summary page 4.

## Most influential descendants
- K230894: NuVasive Modulus ALIF System (2023), 4 descendants of its own
- 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. The Modulus ALIF System 10°-20° lordotic cages may be used as a standalone system. The Modulus ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft 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 Sl, 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 radiographic studies. 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 spondylolisthesis 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 the FDA for use in the lumbar spine in addition to the integrated screws.

Source page: https://510kreport.com/device/K210271
Methodology: https://510kreport.com/methodology