# K022191: Modification to Tenor Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Aug 28, 2002 after 54 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
No predicates in its family tree.
27 later devices descend from it; 2 cite it directly.
0 of 28 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
- K221646: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (2022), 20 descendants of its own
- K223494: CD Horizon Spinal System (2023), 17 descendants of its own
- K233951: CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (2024), 5 descendants of its own
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own
- K071921: Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws) (2007), 5 descendants of its own

## Indications for use
The TENORm Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S 1) 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 fiom L3 to sacrum); and/or (d) who are having the device removed after the development of a solid fusion mass. TENORm Plates are intended for the L5-S 1 pedicle screw indication described above only. The TENORTMSpinal System, when used as a 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, and/or 8) tumor resection. When used for posterior non-pedicle screw fixation, the TENORTMSpinal System is intended for thoracic, lumbar, and sacral (T 1-Sacrum) fixation only.

Source page: https://510kreport.com/device/K022191
Methodology: https://510kreport.com/methodology