# K200316: UNiD IB3D ALIF

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Oct 30, 2020 after 266 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: 21 generations back to K841189 (1984). 330 ancestors in all.
No later device cites it as a predicate yet.
1 of 331 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191134: IB3D Alif, Medicrea International SA (2019) Summary page 4.

## Indications for use
MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and 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. UNiD® IB3D ALIF device 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/K200316
Methodology: https://510kreport.com/methodology