# K100544: Impix Lumbar Interbody Device

- Pathway: 510(k) (Special)
- Applicant: Medicrea Technologies
- Decided: Jul 22, 2010 after 147 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K841189 (1984). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 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.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007). Our reading of the summary gave K072797, FDA’s number for GE Logiq I Comapact Ultrasound, GE Logiq E Compact… (General Electric Co.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ORACLE Spacer”. Summary page 1.
- K073177: Pioneer Intervertebral Fusion Device System, Pioneer Surgical Technology (2008) Summary page 1.
- K080822: VU Apod Intervertabral Body Fusion Device, Theken Spine, LLC (2008) Summary page 1.

## Recalls of this device
- Jul 12, 2023 · Class II · Z-2455-2023: 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 DLIF Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1. DDID 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 DLIF 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/K100544
Methodology: https://510kreport.com/methodology