# K181347: Aries® Lumbar Interbodies

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusion Systems, LLC
- Decided: Aug 15, 2018 after 86 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: 22 generations back to K841189 (1984). 320 ancestors in all.
24 later devices descend from it; 3 cite it directly.
1 of 345 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 4.
- K160547: Cascadia Interbody System, K2m (2016) Summary page 4.
- K162264: Cascadia Interbody System, K2m, Inc. (2016) Summary page 4.
- K172009: Cascadia Interbody System, K2m, Inc. (2017) Summary page 4.
- K172941: CASCADIA Interbody System, K2m (2018) Summary page 4.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 4.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 4.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 4.
- K101302: Aleutian Ibf System, K2m, Inc. (2010) Summary page 4.

## Most influential descendants
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own
- K182987: Genesys Spine 3DP Lumbar Interbody System (2019), 9 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own
- K240326: Solar™ Lumbar Interbody Fusion System (2024), 4 descendants of its own

## Indications for use
The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-0, Aries®-A, and Aries®-L) are interbody fusion devices intended 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 L2 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft 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 cage.

Source page: https://510kreport.com/device/K181347
Methodology: https://510kreport.com/methodology