# K231899: HAtetracell™-C Titanium Cervical IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Oct 17, 2023 after 111 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: 17 generations back to K841189 (1984). 141 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220875: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System, Innovasis, Inc. (2022) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Innovasis HAtetracell™-C Titanium 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 HAtetracell™-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAtetracell™-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/K231899
Methodology: https://510kreport.com/methodology