# K142488: SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Dec 18, 2014 after 105 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: 9 generations back to K841189 (1984). 21 ancestors in all.
116 later devices descend from it; 10 cite it directly.
0 of 138 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.
- K082310: Hollywood, Pacifica, Redondo, Ventura, Seaspine, Inc. (2008) Summary page 5.
- K103297: Redondo-L, Seaspine, Inc. (2011) Summary page 5.
- K082309: Cambria, Seaspine, Inc. (2009) Summary page 5.
- K082712: Theken Spine VU Epod and VU Lpod System, Theken Spine, LLC (2009) Summary page 5.
- K112986: Lateral Fusion Device, Integra Spine (Integra Lifesciences) (2012) Summary page 5.

## Most influential descendants
- K162715: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene (2016), 103 descendants of its own
- K170569: SeaSpine Shoreline ACS - Anterior Cervical Standalone System (2017), 82 descendants of its own
- K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device (2016), 79 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

## 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. 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. The Integra Vu aPOD-L Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft (i.e. autograft). The Integra Vu aPOD-L Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. Degenerative disc disease is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. When used as an intervertebral body fusion device the Vu ePOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K142488
Methodology: https://510kreport.com/methodology