# 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)

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Mar 13, 2019 after 145 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: 19 generations back to K841189 (1984). 235 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 245 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160924: Amendia Interbody Fusion Devices, Amendia, Inc. (2016) Summary page 4.
- K151310: Amendia Interbody Fusion Devices, Amendia, Inc. (2016) Summary page 4.
- K151322: Amendia Interbody Fusion Devices, Amendia, Inc. (2015) Summary page 4.

## Most influential descendants
- 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 (2020), 6 descendants of its own
- 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
- K190618: RIGEL PEEK Anterior Cervical Interbody Fusion System (2019), 1 descendant of its own

## Indications for use
The 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) 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 and/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/K182920
Methodology: https://510kreport.com/methodology