# K163595: IMPIX 3D Print Cages

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Nov 13, 2017 after 327 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K841189 (1984). 168 ancestors in all.
28 later devices descend from it; 5 cite it directly.
1 of 197 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150481: Cascadia Interbody System, K2m, Inc. (2015) Summary page 4.
- K072226: Impix Spacer, Medicrea Technologies (2007) Summary page 4.
- K121760: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 4.
- K083798: Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf, Medicrea Technologies (2010) Summary page 4.
- K151214: ALIF Interfixated System, Nu Vasive, Incorporated (2015) Summary page 4.

## Most influential descendants
- K173782: UNiD Patient Specific 3D printed cage (2018), 23 descendants of its own
- 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

## Recalls of this device
- Jul 12, 2023 · Class II · Z-2452-2023: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- Oct 2, 2019 · Class II · Z-1156-2020: Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

## Indications for use
IMPIX 3D Print cages are 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. IMPIX 3D Print cages are 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/K163595
Methodology: https://510kreport.com/methodology