# K162715: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene

- Pathway: 510(k) (Special)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Oct 28, 2016 after 29 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: 10 generations back to K841189 (1984). 22 ancestors in all.
103 later devices descend from it; 5 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102026: Seaspine Spacer System, Seaspine, Inc. (2011) Summary page 5.
- K142488: SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene, Seaspine, Inc. (2014) Summary page 5.

## Most influential descendants
- K170569: SeaSpine Shoreline ACS - Anterior Cervical Standalone System (2017), 82 descendants of its own
- K190655: SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System (2019), 74 descendants of its own
- K173260: SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System (2017), 67 descendants of its own
- K171046: SeaSpine Cambria System (2017), 62 descendants of its own
- K172926: SeaSpine Vu cPOD, Zuma-C, Complete Cervical (2017), 61 descendants of its own

## Indications for use
SeaSpine® Spacer System – Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, and Ventura NanoMetalene®: 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. Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3‐C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non‐operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

Source page: https://510kreport.com/device/K162715
Methodology: https://510kreport.com/methodology