# K173606: SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device - Pathway: 510(k) (Traditional) - Applicant: SeaSpine Orthopedics Corporation - Decided: Apr 13, 2018 after 143 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: 19 generations back to K841189 (1984). 289 ancestors in all. 59 later devices descend from it; 4 cite it directly. 0 of 349 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, SeaSpine Orthopedics Corporation (2016) Summary page 6. - K121211: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2012) Summary page 6. - K101310: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2010) Summary page 6. - K080822: VU Apod Intervertabral Body Fusion Device, Theken Spine, LLC (2008) Summary page 6. - K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 6. - K101301: Stalif Midline, Centinel Spine (2010) Summary page 6. ## Most influential descendants - K210497: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System (2021), 39 descendants of its own - K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own - K201193: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System (2020), 18 descendants of its own - K210583: SeaSpine WaveForm™ A Interbody System (2021), 14 descendants of its own - K220711: SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System (2022), 10 descendants of its own ## Indications for use When used with the bone screws, the SeaSpine Vu asPOD 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 asPOD 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 >2(F 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. When used with the bone screws, the SeaSpine Vu a*POD Prime 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 asPOD Prime 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 asPOD Prime Intervertebral Body Fusion Device is intended for use with supplemental fixation. The Vu a*POD Prime 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 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. This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocortical 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/K173606 Methodology: https://510kreport.com/methodology