# K983152: Osteonics Spinal System 5.5MM & 10.0MM Bone Screws

- Pathway: 510(k) (Special)
- Applicant: Osteonics Corp.
- Decided: Sep 25, 1998 after 16 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: 1 generation back to K951725 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.
- (no number) Danek TSRH Spinal System: named in the summary without a submission number
- (no number) AcroMed Titanium Bone Screws: named in the summary without a submission number

## Indications for use
The uses for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, as part of the legally marketed Osteonics® Spinal System, are as follows: Non-Pedicular Use; fixation of the T4-S2 spine: Long and short curve scoliosis Vetebral 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 system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

Source page: https://510kreport.com/device/K983152
Methodology: https://510kreport.com/methodology