# K173782: UNiD Patient Specific 3D printed cage

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Apr 25, 2018 after 133 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: 18 generations back to K841189 (1984). 169 ancestors in all.
23 later devices descend from it; 2 cite it directly.
1 of 193 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.

## Most influential descendants
- K182158: UNiD Patient-matched PLIF cage (2019), 21 descendants of its own
- K202034: aprevo Intervertebral Body Fusion Device (2020), 17 descendants of its own
- K190092: UNiD Patient specific 3D printed TLIF cage (2019), 13 descendants of its own
- K222009: aprevo® anterior lumbar interbody fusion device with interfixation (2022), 12 descendants of its own
- K210542: aprevo Transforaminal IBF (2021), 12 descendants of its own

## Indications for use
UNiD 3D printed interbody system device 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 3D printed interbody system 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/K173782
Methodology: https://510kreport.com/methodology