# K243386: Ventris Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Surgical Devices, LLC
- Decided: Apr 22, 2025 after 173 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: 23 generations back to K841189 (1984). 384 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 387 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201671: A-Link Z, Acuity Surgical Devices, LLC (2021) Summary page 7.

## Most influential descendants
- K251335: Tera Lumbar Interbody Fusion System (Various PNs) (2025), 1 descendant of its own
- K254130: C.A. Medical Interbody Fusion System (2026), 0 descendants of its own

## Indications for use
Ventris anterior cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Ventris anterior cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade | spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Ventris 2-screw anterior cages may be used as a stand alone device only when two (2) vertebral body bone screws are used. Ventris 4-screw anterior cages may be used as a stand alone device only when at least two (2) vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use Ventris anterior cages with fewer than two (2) screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used. Ventris anterior cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. When used to treat ASD, or when cages with more than 20° of lordosis are used, Ventris anterior cages must be used with a supplemental spinal fixation system cleared for use in the lumbosacral spine and cannot be used as a stand alone. Ventris anterolateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Ventris anterolateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. Ventris anterolateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade | spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Ventris anterolateral cages are intended to be used with a supplemental spinal fixation system cleared for use in the lumbosacral spine. Ventris lateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Ventris lateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. Ventris lateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade | spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Ventris lateral cages are intended to be used with a supplemental spinal fixation system cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K243386
Methodology: https://510kreport.com/methodology