Class Class II
Ventris Intervertebral Body Fusion Device (K243386)
Description
Ventris Intervertebral Body Fusion Device by Acuity Surgical Devices, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243386
Clearance Date2025-04-22
Clearance TypeTraditional
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243386
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ventris Intervertebral Body Fusion Device (K243386) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232282 | aprevo® anterior and lateral lumbar interbody fusion device... | Carlsmed, Inc. | 2024 |
| K230894 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2023 |
| K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023 |
| K222561 | Align | Acuity Surgical Devices, LLC | 2022 |
| K201671 | A-Link Z | Acuity Surgical Devices, LLC | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC | 2025 |
Trace the full predicate network for K243386
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.