# K240126: ProAM ALIF System

- Pathway: 510(k) (Traditional)
- Applicant: Pro Surgical, Inc.
- Decided: May 3, 2024 after 108 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: 32 generations back to K841189 (1984). 1,436 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 1,439 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230894: NuVasive Modulus ALIF System, Nu Vasive, Incorporated (2023) Summary page 5.
- K223413: Pisces™-SA STANDALONE ALIF Interbody System, Osseus Fusion Systems (2023) Summary page 5.
- K222554: EL CAPITAN Anterior Lumbar Interbody Fusion, Astura Medical (2023) Summary page 5.
- K083475: Lucent Magnum, Spinal Elements, Inc. (2009) Summary page 5.
- K232097: IdentiTi ALIF Interbody Systems, Alphatec Spine, Inc. (2023) Summary page 5.

## Most influential descendants
- K251644: ProAM ALIF System (2025), 0 descendants of its own
- K242517: ProAM ACDF System (2024), 0 descendants of its own

## Indications for use
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbrosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The ProAM ALIF System can 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 system must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation. Interbody devices used with three screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation. Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three screws (OLIF devices and 2-Hole ALIF devices) must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation. The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

Source page: https://510kreport.com/device/K240126
Methodology: https://510kreport.com/methodology