# K080822: VU Apod Intervertabral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: Jul 2, 2008 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K841189 (1984). 13 ancestors in all.
708 later devices descend from it; 9 cite it directly.
1 of 722 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050058: Theken Reveal VBR System, Theken Surgical,Llc (2005) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K073348: Lucent Magnum, Spinal Elements, Inc. (2007) Summary page 1.

## Most influential descendants
- K112359: Prow Fusion (2011), 601 descendants of its own
- K130820: Expandable Lumbar Interbody System (2013), 593 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K101310: VU Apod Intervertebral Body Fusion Device (2010), 480 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own

## Recalls of this device
- Oct 19, 2010 · Not classified · Z-1475-2011: The IFU provided with the device contains incorrect information in the Indications for Use Section, stating the following: The Theken Spine Vu a"POD Intervertebral Body Fusion Device is intended for u

## Indications for use
The Theken Spine Vu aPOD 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 interior of the spacer component may be packed with autogenous bone graft material. The Theken Spine Vu aPOD Intervertebral Body Fusion Device is 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/K080822
Methodology: https://510kreport.com/methodology