# K190092: UNiD Patient specific 3D printed TLIF cage

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: May 8, 2019 after 110 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: 19 generations back to K841189 (1984). 170 ancestors in all.
13 later devices descend from it; 1 cites it directly.
1 of 184 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163595: IMPIX 3D Print Cages, Medicrea International SA (2017) Summary page 4.
- K173782: UNiD Patient Specific 3D printed cage, Medicrea International SA (2018) Summary page 4.

## Most influential descendants
- K210542: aprevo Transforaminal IBF (2021), 12 descendants of its own
- K222082: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices (2022), 11 descendants of its own
- K231140: aprevo® transforaminal lumbar interbody fusion device (2023), 6 descendants of its own
- K241332: aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device (2024), 5 descendants of its own
- K241019: aprevo® TLIF-C Articulating System (2024), 4 descendants of its own

## Indications for use
UNiD Patient specific 3D printed TLIF cage is 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 I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNiD Patient specific 3D printed TLIF cage 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/K190092
Methodology: https://510kreport.com/methodology