# K972718: M-2 Anterior Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Oct 1, 1997 after 72 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
No predicates in its family tree.
221 later devices descend from it; 5 cite it directly.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Z-Plate Anterior Fixation System: named in the summary without a submission number

## Most influential descendants
- K052546: Aegis Anterior Lumbar Plate System (2006), 211 descendants of its own
- K070922: Modification to Spinal Usa VBR System (2007), 161 descendants of its own
- K091044: Spinal Usa Anterior Lumbar Plate System (2009), 159 descendants of its own
- K121791: Zou Anterior Lumbar Plate System (2012), 113 descendants of its own
- K101255: Alphatec Spine Anterior Lumbar Plating System (2010), 113 descendants of its own

## Indications for use
The M-2 Anterior Plate System is intended for use in: 1. Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Pseudoarthrosis Spondylolysis Spondylolisthesis Burst fractures/ trauma Tumor Anterior fusion following failed posterior operations Unsuccessful previous anterior surgery Lordotic deformities of the spine The intended levels for treatment with the M-2 Anterior Plate System are T3 to L3. In order to treat levels T3 to L3, plate attachment is from T2 to 14. The M-2 Plate System is intended to treat one motion segment per construct.

Source page: https://510kreport.com/device/K972718
Methodology: https://510kreport.com/methodology