# K220115: ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: May 13, 2022 after 119 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 22 generations back to K841189 (1984). 383 ancestors in all.
No later device cites it as a predicate yet.
1 of 384 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 4.
- 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, MiRus, LLC (2020) Summary page 4.

## Indications for use
The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an interbody fusion device system placed via a variety of open or minimally invasive approaches and indicated for use: » In skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1) » In patients having have received 6 months of nonoperative treatment prior to treatment * With or without screws With autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft Standalone Use (with screws) ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for stand-alone use in patients with DDD or with degenerative spondylolisthesis at one or two contiguous levels only when used with (1) at least three screws per implant (including at least one screw in each endplate) and (2) when < 20° lordotic implants are used. Use with Supplemental Fixation (with or without screws) ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for use with supplemental fixation in patients with Degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, Spinal deformity (degenerative scoliosis or kyphosis), Spondylolisthesis or retrolisthesis, or failed previous fusion (pseudoarthrosis). When used at more than 2 contiguous levels, with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K220115
Methodology: https://510kreport.com/methodology