# K960444: Finn Rod to Rod Connector

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Jan 24, 1997 after 358 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) AcroMed Modular Cross Connector Components: named in the summary without a submission number
- (no number) Dyna-Lok Spinal System Crosslink Plate: named in the summary without a submission number
- (no number) TSRH Spinal System Crosslink: named in the summary without a submission number
- (no number) Isola Spinal System transverse rod connectors: named in the summary without a submission number
- (no number) Rogozinski Spinal Rod System crossbar: named in the summary without a submission number

## Indications for use
The Finn Rod to Rod Connector is used as part of the Rogozinski Spinal Rod System. The Rod to Rod Connector is designed to attach two 1/4* Rogozinski Spinal Rods to provide temporary stability to the lumbosacral spine during the development of a solid spinal fusion. The Finn Rod to Rod Connectors are designed to be part of a construct that consists of Rogozinski rods attached to the spine with hooks, bolts and/or screws. The Finn Rod to Rod Connectors when used in constructs with spinal screws or bolts placed in the pedicles are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral 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. Otherwise, the Finn Rod to Rod Connectors when used in constructs with spinal screws or bolts are intended for sacral iliac attachment only in the treatment of degenerative disc disease of the lumbar spine, pseudoarthrosis, spinal stenosis, scoliosis, spondylolisthesis, fracture, failed back syndrome/unsuccessful previous attempts at spinal fusion, or tumor resection. Degenerative disc disease of the lumbar spine is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Rogozinski System is limited to noncervical spine use. The levels of pedicle screw / bolt use for this system are limited to L3-S1 or iliac screw fixation.

Source page: https://510kreport.com/device/K960444
Methodology: https://510kreport.com/methodology