# K121567: Oracle Lumbar Intervertebral Body Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Accel Spine
- Decided: Sep 26, 2012 after 120 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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 K841189 (1984). 75 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110783: Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage, L&K BIOMED Co., Ltd. (2011) Summary page 2.
- K120063: Venus Lumbar Intervertebral Body Fusion Cage System, L&K BIOMED Co., Ltd. (2012) Summary page 2.
- K121096: Venus Lumbar Intervertebral Body Fusion Cage System, L&K BIOMED Co., Ltd. (2012). Cleared while this submission was under review Summary page 2.
- K100516: Anyplus Peek Cages, GS Medical Co., Ltd. (2010) Summary page 2.
- K083661: Avs TL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K090816: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K092162: 4CIS Peek, Plif and Tlif Cage System, Solco Biomedical Co., Ltd. (2010) Summary page 2.
- K043405: Nuvasive Coroent System, Nuvasive, Inc. (2005) Summary page 2.
- K052210: Nuvasive Coroent Extensure System, Nuvasive, Inc. (2005) Summary page 2.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 2.
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 2.
- K081888: Dynamik Intervertebral Body Fusion Device, Spineart (2009) Summary page 2.
- K101720: Juliet OL, Spineart (2010) Summary page 2.
- K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.
- K112405: Clydesdales Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2.
- K113528: Clydesdale (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2011)

## 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

## Indications for use
Cezann& Lumbar Interbody Fusion Cage System is indicated for intervertebral body fuision procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-SI ODD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DOD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Cezanne Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K121567
Methodology: https://510kreport.com/methodology