# K141187: Impix Alif S/a

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Jan 15, 2015 after 252 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 12 generations back to K841189 (1984). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101301: Stalif Midline, Centinel Spine (2010) Summary page 4.
- K083798: Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf, Medicrea Technologies (2010) Summary page 4.
- K072226: Impix Spacer, Medicrea Technologies (2007) Summary page 4.
- K062083: Synfix -LR, Synthes Spine Co.Lp (2007) Summary page 4.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 4.

## Recalls of this device
- Jul 12, 2023 · Class II · Z-2454-2023: 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
The stand-alone intersomatic IMPIX ALIF S/A implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine 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. Patients should have a satisfactory course of conservative treatment (usually at least six (6) months of non-operative treatment) prior to treatment with an IMPIX-ALIF-S/A stand-alone cage. The IMPIX ALIF S/A devices should be used with the three (3) bone screws (Small Footprint) or four (4) bone screws (Medium, Large Footprints) accompanying the device. Otherwise, an additional fixation system (e.g., pedicle screw system) should be implanted.

Source page: https://510kreport.com/device/K141187
Methodology: https://510kreport.com/methodology