# K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Dec 1, 2016 after 100 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: 18 generations back to K841189 (1984). 288 ancestors in all.
79 later devices descend from it; 5 cite it directly.
0 of 368 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121211: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2012) 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.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- 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
- K181079: SeaSpine Regatta Lateral System (2018), 63 descendants of its own
- K200879: SeaSpine Meridian System, SeaSpine Regatta Lateral System (2020), 60 descendants of its own
- K192132: SeaSpine Beachside System (2019), 59 descendants of its own
- K173606: SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device (2018), 59 descendants of its own

## Indications for use
When used with the bone screws, the SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate™, the Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate™, the Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is intended for use with supplemental fixation. The Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate™, is a stand-alone device. If the Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is used only with the SpinPlate™, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20ࡈ must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

Source page: https://510kreport.com/device/K162351
Methodology: https://510kreport.com/methodology