# K173022: SeaSpine Ventura NanoMetalene System

- Pathway: 510(k) (Special)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Oct 26, 2017 after 28 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 11 generations back to K841189 (1984). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162715: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene, SeaSpine Orthopedics Corporation (2016) Summary page 4.
- K142488: SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene, Seaspine, Inc. (2014) Summary page 4.
- K082310: Hollywood, Pacifica, Redondo, Ventura, Seaspine, Inc. (2008) Summary page 4.
- K102026: Seaspine Spacer System, Seaspine, Inc. (2011) Summary page 4.

## Indications for use
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2‐S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non‐fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non‐operative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation.

Source page: https://510kreport.com/device/K173022
Methodology: https://510kreport.com/methodology