# K072226: Impix Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea Technologies
- Decided: Dec 10, 2007 after 122 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: 1 generation back to P950002 (1996). 4 ancestors in all.
812 later devices descend from it; 11 cite it directly.
1 of 817 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 1.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.

## Most influential descendants
- K073177: Pioneer Intervertebral Fusion Device System (2008), 775 descendants of its own
- K112496: Pioneer Crossfuse II Ibf/VBR System (2011), 604 descendants of its own
- K133623: C-PLUS (2014), 598 descendants of its own
- K133455: Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic (2014), 596 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own

## Indications for use
IMPIX-C Cervical Interbody Device is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft. IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. IMPIX-L 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-L 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/K072226
Methodology: https://510kreport.com/methodology