# K980496: Wright Medical Technology Rod-to-Rod Coupler

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 14, 1998 after 64 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy Motech MOSS Miami Spinal System: named in the summary without a submission number
- (no number) SYNTHES (USA) Universal Modular Spinal System: named in the summary without a submission number

## Indications for use
The Rod-To-Rod Coupler is intended to form a transverse connection between spinal rods in a spinal construct in order to increase the torsional stiffness of the construct. A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass. When not used as a pedicle screw-fixation system, various combinations of the Versalok Posterior Spinal Fixation System components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to: 1. Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors; 2. Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by history and radiographic studies); 3. Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are: * Progressive, despite other forms of treatment, * Detrimental to cardiopulmonary function, » Interfering with spinal mechanics or causing severe back pain, or » Cosmetically unacceptable, progressive, and painful. The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation'instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.

Source page: https://510kreport.com/device/K980496
Methodology: https://510kreport.com/methodology