# K223671: CONDUIT LLIF Straight Inserters

- Pathway: 510(k) (Special)
- Applicant: Enztec Limited
- Decided: Jan 5, 2023 after 29 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: 25 generations back to K841189 (1984). 215 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 217 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212823: DePuy CONDUIT LLIF Angled Inserters, Enztec Limited (2021) Summary page 5.

## Most influential descendants
- K232014: CONDUIT™ ATP Inserters (2023), 0 descendants of its own

## Indications for use
The CONDUIT™ LLIF Straight Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages. EIT Cellular Titanium® LLIF Cage The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are 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. EIT Spine LLIF is to be used with 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/K223671
Methodology: https://510kreport.com/methodology