# K133813: Flxfit Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Expanding Orthopedics, Inc.
- Decided: Jul 15, 2014 after 211 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: 14 generations back to K841189 (1984). 70 ancestors in all.
137 later devices descend from it; 3 cite it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112095: Acculif TL-Peek Ibf Cage, Coalign Innovations, Inc. (2011)
- K123281: Acculif TL-Peek Cage, Coalign Innovations, Inc. (2013) Summary page 1.
- K123752: Acculif TL and PL Cage, Coalign Innovations, Inc. (2013) Summary page 1.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 1.
- K090566: Pathway Avid, Custom Spine, Inc. (2009) Summary page 1.
- K080537: L-Varlock, Kiscomedica S.A. (2008) Summary page 1.

## Most influential descendants
- K153400: ProLift Expandable System (2016), 72 descendants of its own
- K171519: FLXfit™ (2017), 71 descendants of its own
- K180078: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System (2018), 55 descendants of its own
- K183064: TxTi IBF System (2019), 48 descendants of its own
- K201614: TxTiHA IBF System, AxTiHA Stand-Alone ALIF System (2020), 47 descendants of its own

## Indications for use
The E01 FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmned by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The E01 FLXfit device is intended to be used with supplemental spinal fixation system and with autogenous bone graft.

Source page: https://510kreport.com/device/K133813
Methodology: https://510kreport.com/methodology