# K182158: UNiD Patient-matched PLIF cage

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Jul 15, 2019 after 340 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.
21 later devices descend from it; 3 cite it directly.
1 of 192 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
- K202034: aprevo Intervertebral Body Fusion Device (2020), 17 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
- K222082: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices (2022), 11 descendants of its own
- K241477: aprevo® anterior lumbar interbody fusion device with interfixation (2024), 6 descendants of its own

## Indications for use
UNiD Patient-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels form 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 bone graft. UNiD Patient-matched PLIF 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/K182158
Methodology: https://510kreport.com/methodology