# K970635: Titanium Spinal Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc., Orthopaedic Div.
- Decided: Aug 14, 1997 after 175 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
72 later devices descend from it; 6 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K033352: Vertebron PSS Pedicle Screw System (2004), 62 descendants of its own
- K043152: Vertebron PSS Pedicle Screw System (2005), 61 descendants of its own
- K051716: Vertebron PSS Pedicle Screw System (2005), 56 descendants of its own
- K071376: Modification to Vertebron PSS Pedicle Screw System (2007), 49 descendants of its own
- K073430: Valeo Pedicle Screw Spinal System (2008), 24 descendants of its own

## Indications for use
The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine and the anterior vertebral bodies of the cervical spine. Intended uses for this device include anterolateral screw fixation to the noncervical spine, lumbar spine, T6-L5 spine and to the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery. When used as a nonpedicle posterior system consisting of hooks, crosslinks, and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery. When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-S1. The devices are for single use. Cementless or cement fixation is not applicable to this device. These devices have not been submitted to the FDA for different intended uses.

Source page: https://510kreport.com/device/K970635
Methodology: https://510kreport.com/methodology