# K030369: Opus Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 8, 2003 after 185 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 K984251 (1999). 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)
- K993402: Opus Spinal System, Howmedica Osteonics Corp. (1999) Summary page 1.
- K014229: Modification to Opus Spinal System, Howmedica Osteonics Corp. (2002)
- K003490: Opus Rod Fixation System, Howmedica Osteonics Corp. (2000) Summary page 1.
- (no number) OSS/Diapason Spinal System titanium hooks: named in the summary without a submission number
- (no number) Xia Spinal System titanium hooks: named in the summary without a submission number

## Indications for use
The Opusm Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The Opusr” Spinal System is also intended to be used in conjunction with the titanium hooks from the OSS/Diapason Spinal System and the Xia Spinal System. The Opusm Spinal System is also intended to be used in conjunction with the Multi-Axis Cross Connectors.

Source page: https://510kreport.com/device/K030369
Methodology: https://510kreport.com/methodology