# K991528: Modification to Tenor Spinal System-Rod/Bolt Connector

- Pathway: 510(k) (Special)
- Applicant: Danek Medical, Inc.
- Decided: May 28, 1999 after 25 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 no predicate by number.

## Indications for use
The TENORT™™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (8) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar ~ first sacral (L5-S1) vertebral 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 (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of 2 solid fusion mass. TENORT™ Plates are intended for the LS-S1 pedicle screw indication described above only. The TENOR™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2. Pseudarthrosis; 3. Stenosis; 4. Spondylolisthesis; 5. Spinal deformities: scoliosis, kyphosis, lordosis; 6. Fracture; 7. Unsuccessful previous attempts at spinal fusion; 8. Tumor resection. When used for posterior non-pedicle screw fixation, the TENORT™ Spinal System is intended for thoracic, lumbar, and sacral (T1 ~ Sacrum) fixation only.

Source page: https://510kreport.com/device/K991528
Methodology: https://510kreport.com/methodology