# K220875: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Aug 26, 2022 after 154 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 16 generations back to K841189 (1984). 140 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181115: CxHA PEEK Cervical IBF System, Innovasis, Inc. (2018) Summary page 4.
- K173030: Vertera Spine Cohere Cervical Interbody Fusion Device, Nu Vasive, Incorporated (2017) Summary page 4.

## Most influential descendants
- K231899: HAtetracell™-C Titanium Cervical IBF System (2023), 2 descendants of its own
- K262025: Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (2026), 0 descendants of its own
- K250076: Endeavor™ Stand-Alone Cervical IBF System (2025), 0 descendants of its own
- K223510: Matrix HA Fusion Porous Cervical IBF System (2022), 0 descendants of its own

## Indications for use
The Innovasis HAcancellous PEEK-C Porous HA PEEK Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The HAcancellous PEEK-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAcancellous PEEK-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.

Source page: https://510kreport.com/device/K220875
Methodology: https://510kreport.com/methodology