# K180078: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Apr 17, 2018 after 97 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: 21 generations back to K841189 (1984). 212 ancestors in all.
55 later devices descend from it; 4 cite it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151785: Px HA PEEK IBF System, Innovasis, Inc. (2015) Summary page 4.
- K143740: Battalion Universal Spacer System, Alphatec Spine, Inc. (2015) Summary page 4.
- K150500: Px PEEK IBF System, Innovasis, Inc. (2015) Summary page 4.
- K171633: NuVasive TLX Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.
- K171519: FLXfit™, Expanding Orthopedics, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K222028: 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 (2022), 28 descendants of its own

## Recalls of this device
- Aug 14, 2024 · Class II · Z-3163-2024: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.

## Indications for use
The Innovasis PEEK IBF System (Px, Px HA and TxHA) 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 a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine. Px® and Px HA® devices are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach. TxHA™ devices are placed via a transforaminal (TLIF) 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 is intended to be packed with autograft.

Source page: https://510kreport.com/device/K180078
Methodology: https://510kreport.com/methodology