# K964544: Osteonics Spinal System - Variable Offset Connector Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Feb 11, 1997 after 90 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) TSRH™ 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 Variable Offset 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 ELI Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6Al4V ELI alloy components are intended for use only with other Ti6Al4V ELI alloy components. The Osteonics® Spinal System, including the subject additional components, is intended for fixation of the T4-S2 spine. All bone screws are indicated for sacral fixation, or for limited pedicular fixation. When used as a pedicle screw system, the system is intended only for use with autogenous bone graft in order to facilitate fusions of the L5-S1 joint in patients with grade 3 or 4 spondylolisthesis. The screws are not intended for placement in the pedicles above L3, and are intended for removal after development of a solid fusion mass. 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 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/K964544
Methodology: https://510kreport.com/methodology