# K051044: Arctec Semirigid Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Altiva Corp.
- Decided: Oct 7, 2005 after 165 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
Longest line of descent: 2 generations back to K955348 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930353: Simmons Plating System Bolt and Screw, Smith & Nephew, Inc. (1995) Summary page 1.
- K962784: Ultium Spinal Plating System, Smith & Nephew, Inc., Orthopaedic Div. (1996) Summary page 1.
- K051216: Hydralok System, Altiva Corp. (2005). Cleared while this submission was under review
- K983899: Thoracolumbar Spinal Rod System (Empower), United States Surgical, A Division of Tyco Healthc (1998) Summary page 1.
- K964024: Depuy Motech Titanium Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 1.

## Indications for use
The ArcTecTM Semi-Rigid Plating System is intended for posterior, noncervical, pedicle fixation in order 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 thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the ArcTecTM Semi-Rigid Plating System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

Source page: https://510kreport.com/device/K051044
Methodology: https://510kreport.com/methodology