# K063668: Roc Lumbar System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: May 18, 2007 after 158 days
- Product code: MNI (Orthosis, Spinal Pedicle 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
Longest line of descent: 4 generations back to K951116 (1995). 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)
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 2.
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 2.

## Indications for use
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients. The ROCEM Lumbar 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/K063668
Methodology: https://510kreport.com/methodology