# K132991: C-Box Peek Cervical Ibf

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Feb 12, 2014 after 141 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: 13 generations back to K841189 (1984). 76 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 2.
- K130699: Aleutian Spinal System, K2m, Inc. (2013) Summary page 2.
- K120486: Avs as Peek Spacer, Stryker Spine (2012) Summary page 2.
- K103660: Lanx Cervical Intervertebral Body Fusion System, Lanx, Inc. (2011) Summary page 2.

## Most influential descendants
- K181115: CxHA PEEK Cervical IBF System (2018), 8 descendants of its own
- 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

## Indications for use
The Innovasis C-Box PEEK Cervical IBF device 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 C-Box device is to be used with supplemental fixation, such as the Innovasis Opteryto Cervical Plate System. The C-Box device is intended to be used with autograft bone and is to be implanted via an open, anterior approach.

Source page: https://510kreport.com/device/K132991
Methodology: https://510kreport.com/methodology