# K172926: SeaSpine Vu cPOD, Zuma-C, Complete Cervical - Pathway: 510(k) (Traditional) - Applicant: SeaSpine Orthopedics Corporation - Decided: Dec 21, 2017 after 87 days - Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical) - 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: 17 generations back to K841189 (1984). 182 ancestors in all. 61 later devices descend from it; 1 cites it directly. 1 of 244 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K171046: SeaSpine Cambria System, SeaSpine Orthopedics Corporation (2017) Summary page 6. - K111675: VU C*Pod Intervertebral Body Fusion Device, Theken Spine, LLC (2011) Summary page 6. - K101363: VU Cpod Intervertebral Bodu Fusion Device, Musculoskeletal Clinical Regulatory Advisers (2010) Summary page 6. - K050058: Theken Reveal VBR System, Theken Surgical,Llc (2005) Summary page 6. - K032064: Theken Cpod/Lpod Vertebral Body Replacement System, Theken Surgical,Llc (2004) Summary page 6. - K102323: Cervical Standalone Intervertebral Body Fusion Device, Theken Spine, LLC (2010) Summary page 6. - K092521: ZUMA-C, Seaspine, Inc. (2010) Summary page 6. ## Most influential descendants - K183083: Shoreline Cervical Interbody RT System (2019), 60 descendants of its own - 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 - K201646: Shoreline ACS (Anterior Cervical System) (2020), 20 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 ## Indications for use The Vu c•POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Vu c•POD implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c•POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems. Zuma-C is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation. The Complete Cervical Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Complete Cervical implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had six (6) weeks of non-operative treatment. The cervical device is to be used with two titanium alloy screws which accompany the implant. Source page: https://510kreport.com/device/K172926 Methodology: https://510kreport.com/methodology