# K131981: Cezanne II Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Accel Spine
- Decided: Oct 9, 2013 after 103 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 60 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 1.
- K102322: Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant (Tlif); Great White Implants (Alif), Omni Surgical, L.P. (2011) Summary page 1.
- K103666: Lanx Lateral, Lanx, Inc. (2011) Summary page 1.

## Most influential descendants
- K192863: MONDRIAN Lumbar Interbody Fusion Cage System (2020), 3 descendants of its own
- K213641: MONDRIAN ALIF Cage with Supplementary Fixation Plate (2022), 1 descendant of its own
- K231715: MONDRIAN™ Anterior Lumbar Plate System (2024), 0 descendants of its own
- K220513: NITRO Interbody Fusion Cage System Family (2023), 0 descendants of its own
- K212389: Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF (2021), 0 descendants of its own

## Recalls of this device
- Aug 21, 2019 · Class II · Z-2504-2020: Reports received of the device fracturing during insertion.
- Aug 21, 2019 · Class II · Z-2501-2020: Reports received of the device fracturing during insertion.
- Aug 21, 2019 · Class II · Z-2502-2020: Reports received of the device fracturing during insertion.
- Aug 21, 2019 · Class II · Z-2503-2020: Reports received of the device fracturing during insertion.

## Indications for use
The Cezanne 1IInterbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (ODD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K131981
Methodology: https://510kreport.com/methodology