# K954696: Rogozinski Thoracolumbar Spinal Rod

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Mar 11, 1996 after 151 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.
24 later devices descend from it; 3 cite it directly.
0 of 25 devices 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) Harrington “Lag” Screw: named in the summary without a submission number
- (no number) ISOLA® Spinal System: named in the summary without a submission number
- (no number) CD 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) TSRH™ Spinal System: named in the summary without a submission number
- (no number) Paragon™ Posterior Spinal System: named in the summary without a submission number
- (no number) Unit Rod System: named in the summary without a submission number
- (no number) MOSS™ Modular Segmental Spinal Instrumentation System: named in the summary without a submission number
- (no number) Modulock™ Posterior Spinal Fixation System: named in the summary without a submission number
- (no number) Wiltse System of Internal Fixation: named in the summary without a submission number

## Most influential descendants
- K150417: Astra Spine System (2015), 21 descendants of its own
- K211323: ASTRA Spine System (2021), 12 descendants of its own
- K223273: ASTRA Spine System (2022), 8 descendants of its own
- K162786: PASS LP Spinal System (2017), 6 descendants of its own
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own

## Indications for use
Posterior pedicle screw fixation: The Rogozinski Thoracolumbar Spinal Rod System Direct ("U"-shaped head) and Offset ("T"-shaped head) screws when placed in the pedicles of vertebral levels L3 to S1 ar¢ intended cnly 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; and (c) who are having the device fixed or attached to the lumbar and sacral spine. Otherwise, the Direct and Offset Screws are intended only for sacral/iliac attachment as specified below. Posterior hook and/or sacraliiliac screw fixation: The Rogozinski [horacolumbar Spinal Rod System is intended for the treatment of degenerative disc disease (defined as spinal instability and one or more of the following: decreased disc height, ridging of vertebral end plates, osteophyte formation, scarring or thickening of ligamentous tissues and/or changes in facet joint morphology); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; unsuccessful previous attempts at spinal fusion; or turnor resection. The Rogozinski Thoracolumbar Spinal Rod system is limited to non-cervical use.

Source page: https://510kreport.com/device/K954696
Methodology: https://510kreport.com/methodology