# K101363: VU Cpod Intervertebral Bodu Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Clinical Regulatory Advisers
- Decided: Dec 16, 2010 after 216 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: 11 generations back to K841189 (1984). 51 ancestors in all.
78 later devices descend from it; 5 cite it directly.
1 of 130 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082801: Phantom Plus Cage System, Us Spine (2008)
- K081614: Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages, Interbody Innovations, Llp (2008) Summary page 2.
- K080588: Scient'x Tribeca VBR, Scient'X USA, Inc. (2008) Summary page 2.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 2.
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 2.
- K091873: Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S, Spineart (2009) Summary page 2.

## Most influential descendants
- K111675: VU C*Pod Intervertebral Body Fusion Device (2011), 62 descendants of its own
- K172926: SeaSpine Vu cPOD, Zuma-C, Complete Cervical (2017), 61 descendants of its own
- 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

## 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 of radiographic studies. The Vu c-POD implants are to be used with autogenous bone graft 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 Jntervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Integra Spine Manta Ray or the Integra Spine Tether systems.

Source page: https://510kreport.com/device/K101363
Methodology: https://510kreport.com/methodology