# K050078: Roc Lumbar Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec/Nexmed
- Decided: Feb 18, 2005 after 36 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 its predicate without a number.
- (no number) TiMX plating system offered by Depuy Spine: named in the summary without a submission number
- (no number) Simmons plating system offered by Smith & Nephew: named in the summary without a submission number

## Indications for use
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. The ROC Lumbar Plating when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbosacral spine: 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 - S1.

Source page: https://510kreport.com/device/K050078
Methodology: https://510kreport.com/methodology