# K090228: Roc Lumbar Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Apr 29, 2009 after 89 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
It is intended that this device, in any system configuration, be removed after development of solid fusion mass of spinal segments in skeletally mature patients. The ROC Lumbar Plating System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 - SI.

Source page: https://510kreport.com/device/K090228
Methodology: https://510kreport.com/methodology