# K232014: CONDUIT™ ATP Inserters

- Pathway: 510(k) (Special)
- Applicant: Enztec Limited
- Decided: Sep 1, 2023 after 57 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). 216 ancestors in all.
No later device cites it as a predicate yet.
1 of 217 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223671: CONDUIT LLIF Straight Inserters, Enztec Limited (2023) Summary page 5.

## Indications for use
The CONDUIT TM ATP Inserters are intended to be used with the EIT Cellular Titanium@ LLIF Cages. The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano- scale 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-S 1. 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/K232014
Methodology: https://510kreport.com/methodology