# K050189: Techtonix System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Feb 16, 2005 after 20 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991055 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991055: Osteonics Spinal System- Rod/ Plate System, Howmedica Osteonics Corp. (1999) Summary page 1.

## Indications for use
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System Rod/Plate System and Techtonix T System are indicated for: • Long and short curve scoliosis • Vertebral fracture or dislocation • Spondylolisthesis • Degenerative disc disease (defined as back pain of discogneic origin with degeneration of the disc confirmed by history and radiographic studies) • Previously failed fusion • Spinal tumor Pedicular Use: • When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics® Spinal System Rod/Plate System and Techtonix TM System are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). • In addition, the Osteonics® Spinal System Rod/Plate System and Techtonix System are indicated for pedicde screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K050189
Methodology: https://510kreport.com/methodology