# K983899: Thoracolumbar Spinal Rod System (Empower)

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Dec 22, 1998 after 49 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K965224 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965224: Empower Anterior Direct Screws, Smith & Nephew Richards, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K854696: OP II Visible Light Curing System, Almore Intl., Inc. (1986). Our OCR of the scanned summary read K854696, FDA’s number for OP II Visible Light Curing System (Almore Intl., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “USSC's Surgical Dynamics™ Thoracolumbar Spinal Rod (Empower) System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K051044: Arctec Semirigid Plating System (2005), 0 descendants of its own

## Indications for use
Non-Pedicle Screw Fixation When used as an anterior spinal system the Thoracolumbar Spinal Rod System is intended for the treatement of DOD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Thoracolumbar Spinal Rod System is limited to non-cervical use. When used as a posterior, non-pedicie spinal system (consisting of hooks and sacralliliac screws), the Thoracolumbar Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyohosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Thoracelumbar Spinal Rod System is limited to non-cervical use. Pedicle Screw Fixation When used as a pedicle screw system, in the spine of skeletally mature patients, the Thoracolumbar Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous btone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device remaved after the development of a solid fusion mass. In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Thoracolumbar Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphesis, spinal tumor, and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K983899
Methodology: https://510kreport.com/methodology