# K121581: Box Peek VBR System,

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Oct 17, 2012 after 140 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 8 generations back to K841189 (1984). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062151: Box Peek VBR System, Innovasis, Inc. (2006) 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.

## Most influential descendants
- K190684: LxHA PEEK Lateral IBF System (2019), 0 descendants of its own

## Indications for use
The Innovasis Box PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-SI). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either an anterior or anterolateral (A-Box) or lateral (L-Box) approach. This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excellafl Spinal System. The interior of the Box implants is intended to be packed with autograft.

Source page: https://510kreport.com/device/K121581
Methodology: https://510kreport.com/methodology