# K962784: Ultium Spinal Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc., Orthopaedic Div.
- Decided: Oct 2, 1996 after 77 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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) Simmons Plating System: named in the summary without a submission number
- (no number) Rogozinski Spinal Rod System: named in the summary without a submission number
- (no number) Steffee Plating System (VSP): named in the summary without a submission number
- (no number) Dynalok System: named in the summary without a submission number

## Most influential descendants
- K160982: Sphynx™ (2016), 0 descendants of its own
- K053070: Contour II Spinal System (2006), 0 descendants of its own
- K051044: Arctec Semirigid Plating System (2005), 0 descendants of its own

## Indications for use
Posterior Fixation / Attachment (Pedicle fixation): The Ultium Spinal Plating System bolts when 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. When used as a pedicle screw system, the bolts may be used for the indications specified previously to affix the plates to vertebral levels L3 to S1 inclusive. Anterior Fixation / Attachment (anterolateral intervertebral bodies). The Ultium Spinal Plating System when attached anterolaterally to the vertebral bodies of levels T10 to S1, inclusive, is intended for the treatment of: degenerative disc disease (defined as back pain of discogenic orgin with degeneration of the disk confirmed by historical and radiographic studies); pseudarthrosis, stenosis, scoliosis, spondylolisthesis; unsuccessful previous attempts at spinal fusion; or tumor resection.

Source page: https://510kreport.com/device/K962784
Methodology: https://510kreport.com/methodology