# K964304: Osteonics Spinal System-Toploading Transverse Connector Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jan 17, 1997 after 80 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
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) Osteonics® Spinal System: named in the summary without a submission number
- (no number) TSRH™ Spinal System: named in the summary without a submission number
- (no number) GDLH™ Posterior Spinal System: named in the summary without a submission number
- (no number) ISOLA Spinal System: named in the summary without a submission number

## Indications for use
The subject components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein, are available in either ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6Al4V Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6Al4V alloy components are intended for use only with other Ti6Al4V alloy components. The specific indications of the Osteonics® Spinal System. including the subject additional components, are stated below: For non-pedicular use: 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). For 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 LS-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/K964304
Methodology: https://510kreport.com/methodology