# K223688: CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medos International Sàrl
- Decided: Mar 8, 2023 after 89 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: 26 generations back to K841189 (1984). 394 ancestors in all.
No later device cites it as a predicate yet.
1 of 395 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty, Depuy Spine (2022) Summary page 4.
- K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage, Eit Emerging Implant Technologies GmbH (2020) Summary page 4.
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF, Eit Emerging Implant Technologies GmbH (2018) Summary page 4.
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 4.
- K162358: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System, Synthes USA Products, LLC (2016) Summary page 4.
- K221325: CONDUIT Lateral Switch Plate, Medos International SARL (2022) Summary page 4.
- K210728: CONDUIT Instruments, Medos International SARL (2021) Summary page 4.

## Indications for use
The CONDUIT™ LLIF Cages with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. CONDUIT™ LLIF Cage is to be used with supplemental fixation. The CONDUIT™ LLIF Cages (>20 degrees) must be used with CONDUIT™ Lateral Switch Plate and supplemental fixation. When used with or without the CONDUIT™ Lateral Switch Plate, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. 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/K223688
Methodology: https://510kreport.com/methodology