# K014229: Modification to Opus Spinal System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 25, 2002 after 30 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
Longest line of descent: 3 generations back to K984251 (1999). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 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.
- K013688: Modification to Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 1.

## Most influential descendants
- K030369: Opus Spinal System (2003), 0 descendants of its own

## Indications for use
The Multi-Axis Cross-Connectors are intended to be used with the other components of the Opus Spinal System. 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/K014229
Methodology: https://510kreport.com/methodology