# K212823: DePuy CONDUIT LLIF Angled Inserters

- Pathway: 510(k) (Traditional)
- Applicant: Enztec Limited
- Decided: Nov 1, 2021 after 59 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: 24 generations back to K841189 (1984). 214 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 218 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210728: CONDUIT Instruments, Medos International SARL (2021) Summary page 5.
- 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.

## Most influential descendants
- K223671: CONDUIT LLIF Straight Inserters (2023), 1 descendant of its own
- K232014: CONDUIT™ ATP Inserters (2023), 0 descendants of its own
- K220449: DePuy CONDUIT LLIF SQUID Inserter (2022), 0 descendants of its own

## Indications for use
The DePuy CONDUIT™ LLIF Angled 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 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/K212823
Methodology: https://510kreport.com/methodology