# K984375: Osteonics Spinal System - Sacral Offset Connector Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Apr 30, 1999 after 144 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.
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 its predicate without a number.
- (no number) Tacoma™ Sacral Plate System: Sofamor Danek: named in the summary without a submission number
- (no number) Saddle with Anchor™ Fixation System: Advanced Spine Fixation Systems, Inc.: named in the summary without a submission number

## Indications for use
The uses for the legally marketed Osteonics® Spinal System are as follows: As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for: Long and short curve scoliosis Vertebral fracture or dislocation Spondylolisthesis Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Previously failed fusion Spinal tumor Pedicular Use: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics 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 Osteonics 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 with 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/K984375
Methodology: https://510kreport.com/methodology