# K070385: TI-Tamed Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ti-Tamed (Pty), Ltd.
- Decided: Jul 31, 2009 after 903 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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 K955348 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 1.
- K081952: Synergy Spinal System (6.35 Polaris), Biomet Spine (2008). Cleared while this submission was under review Summary page 1.

## Indications for use
The Ti-TaMED Spinal System is intended for immobilization and stabilization of the spine as an adjunct to fusion for use in anterior, anterolateral, or posterior non-cervical pedicle and non-pedicle fixation for spinal conditions in skeletally mature patients with significant mechanical instability or deformity requiring fusion of the thoracic, lumbar or sacral spine secondary to the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K070385
Methodology: https://510kreport.com/methodology