# K993402: Opus Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 20, 1999 after 73 days
- Product code: MNI (Orthosis, Spinal Pedicle 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
Longest line of descent: 1 generation back to K951725 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951725: Osteonics Spinal System, Osteonics Corp. (1995) Summary page 1.

## Most influential descendants
- K014229: Modification to Opus Spinal System (2002), 1 descendant of its own
- K030369: Opus Spinal System (2003), 0 descendants of its own

## Indications for use
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Opus™ Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, the Opus™ Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K993402
Methodology: https://510kreport.com/methodology