# K193457: AUDERE Lumbar Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Met One Technologies
- Decided: May 12, 2020 after 148 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). 89 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160699: VIRTU Lumbar Spacer System, Met 1 Technologies, LLC (2016) Summary page 5.
- K122097: Patriot Spacers, Globus Medical, Inc. (2012) Summary page 5.
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif, Tyber Medical, LLC (2013) Summary page 5.
- K112095: Acculif TL-Peek Ibf Cage, Coalign Innovations, Inc. (2011) Summary page 5.

## Most influential descendants
- K230851: Kodiak Lumbar Spacer System (2023), 0 descendants of its own

## Indications for use
The AUDERE Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the AUDERE Lumbar Spacer System. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AUDERE Lumbar Spacer System. The AUDERE Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K193457
Methodology: https://510kreport.com/methodology