# K191906: MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: May 18, 2020 after 307 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: 20 generations back to K841189 (1984). 288 ancestors in all.
6 later devices descend from it; 3 cite it directly.
1 of 295 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182920: MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF), MiRus, LLC (2019) Summary page 4.
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 4.
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF, Eit Emerging Implant Technologies GmbH (2018) Summary page 4.

## Most influential descendants
- K212811: Ti3Z Lumbar Interbody System (2022), 3 descendants of its own
- K230731: Zavation ALIF System (2023), 2 descendants of its own
- K233509: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System (2024), 1 descendant of its own
- K250769: Dakota LP System (2025), 0 descendants of its own
- K232154: MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation (2023), 0 descendants of its own

## Indications for use
The MiRus™ 3D Printed Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Source page: https://510kreport.com/device/K191906
Methodology: https://510kreport.com/methodology