# K121323: Medicrea International Anterior Lumbar Plate

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International
- Decided: Jul 18, 2012 after 77 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922543 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101255: Alphatec Spine Anterior Lumbar Plating System, Alphatec Spine, Inc. (2010) Summary page 1.
- K091044: Spinal Usa Anterior Lumbar Plate System, Spinal USA (2009) Summary page 1.
- K080429: Modificaton to: Pyramid +4 Anterior Lumbar Plate System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 1.

## Indications for use
MEDICREAS INTERNATIONAL anterior lumbo-sacral plate system is designed to be used at L5/S1 level. It is intended for use as anteriorly placed supplemental fixation device via the anterior surgical approach below the great vessel bifurcation. The device is intended as a temporary fixation device until fusion is achieved. MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is intended for anterior lumbar spine at L5/S1 level, for the following indications: 1. Degenerative Disc Disease (ODD) at L5/SI level. (ODD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) 2. Pseudoarthrosis 3. Spondylolysis 4. Trauma (i.e., fracture or dislocation) 5. Spinal stenosis 6. Deformities and or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) 7. Tumor 8. Failed previous fusion. MEDICREAS INTERNATIONAL anterior lumbo-sacral plate is intended to be used with autograft and or allograft as an adjunct to fusion. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage and a lumbo-sacral plate for degenerative conditions.

Source page: https://510kreport.com/device/K121323
Methodology: https://510kreport.com/methodology