# K181115: CxHA PEEK Cervical IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Jul 16, 2018 after 80 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: 14 generations back to K003155 (2001). 116 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172674: Sapphire Cervical Implant System, Sapphire Medical Group (2017) Summary page 4.
- K122444: Cervical Cage, Eisertech, LLC (2012) Summary page 4.
- K132991: C-Box Peek Cervical Ibf, Innovasis, Inc. (2014) Summary page 4.

## Most influential descendants
- K220875: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (2022), 4 descendants of its own
- K231899: HAtetracell™-C Titanium Cervical IBF System (2023), 2 descendants of its own
- K222041: CYGNUS-C Standalone ACIF System (2023), 1 descendant 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
- K242303: MOD-C (2026), 0 descendants of its own

## Indications for use
The Innovasis CxHA 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 CxHA device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The CxHA device is intended to be used with autograft bone and is to be implanted via an anterior approach.

Source page: https://510kreport.com/device/K181115
Methodology: https://510kreport.com/methodology