# K191134: IB3D Alif

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Oct 30, 2019 after 184 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: 20 generations back to K841189 (1984). 329 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 331 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 4.
- K170851: Anterior Spine Truss System (STS) Interbody Fusion Device, 4Web, Inc. (2017) Summary page 4.
- K163595: IMPIX 3D Print Cages, Medicrea International SA (2017) Summary page 4.

## Most influential descendants
- K200316: UNiD IB3D ALIF (2020), 0 descendants of its own

## Indications for use
MEDICREA® INTERNATIONAL IB3D ALIF device is indicated for spinal 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 I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IB3D ALIF Device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K191134
Methodology: https://510kreport.com/methodology