# K083798: Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea Technologies
- Decided: May 19, 2010 after 513 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: 2 generations back to P950002 (1996). 5 ancestors in all.
32 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072226: Impix Spacer, Medicrea Technologies (2007) Summary page 1.

## Most influential descendants
- K163595: IMPIX 3D Print Cages (2017), 28 descendants of its own
- 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

## Recalls of this device
- Jul 12, 2023 · Class II · Z-2457-2023: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- Jul 12, 2023 · Class II · Z-2453-2023: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

## Indications for use
IMPIX Lumbar Interbody 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. IMPIX Lumbar Interbody 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/K083798
Methodology: https://510kreport.com/methodology