# K171519: FLXfit™

- Pathway: 510(k) (Traditional)
- Applicant: Expanding Orthopedics, Inc.
- Decided: Sep 15, 2017 after 114 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 15 generations back to K841189 (1984). 71 ancestors in all.
71 later devices descend from it; 2 cite it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133813: Flxfit Intervertebral Body Fusion Device, Expanding Orthopedics, Inc. (2014) Summary page 4.
- K080537: L-Varlock, Kiscomedica S.A. (2008) Summary page 4.

## Most influential descendants
- 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
- K211805: IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System (2021), 38 descendants of its own
- K220782: 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, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own

## Recalls of this device
- Oct 20, 2022 · Class II · Z-0954-2023: Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

## Indications for use
The EOI FLXfit™ 15 and 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 confirmed 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 EOI FLXfit™ 15 and FLXfit™ devices are intended to be used with supplemental spinal fixation system and with autogenous bone graft. Important: FLXfit™ 15 must be applied in combination with posterior fusion system such as the EOI Spinal System.

Source page: https://510kreport.com/device/K171519
Methodology: https://510kreport.com/methodology