# K190684: LxHA PEEK Lateral IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Jun 17, 2019 after 91 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: 22 generations back to K841189 (1984). 219 ancestors in all.
No later device cites it as a predicate yet.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121581: Box Peek VBR System,, Innovasis, Inc. (2012) Summary page 4.
- K180078: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System, Innovasis, Inc. (2018) Summary page 4.

## Indications for use
The Innovasis® LxHA™ PEEK Lateral IBF 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-S1). 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 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed using a lateral approach. This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant device is intended to be packed with autograft.

Source page: https://510kreport.com/device/K190684
Methodology: https://510kreport.com/methodology