# K965224: Empower Anterior Direct Screws

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: May 8, 1997 after 129 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.
30 later devices descend from it; 2 cite it directly.
0 of 31 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 no predicate by number.

## Most influential descendants
- K983904: Rogozinski Spinal Rod System (1998), 27 descendants of its own
- K031595: U & I America Spinal Hook System (2003), 14 descendants of its own
- K100757: Tilock Pedicle Screw System (2010), 9 descendants of its own
- K103671: Genesys Spine Tilock System (2011), 8 descendants of its own
- K152039: Genesys Spine TiLock2 Spinal System (2015), 7 descendants of its own

## Indications for use
The Thorocolumbar Spinal System consists of single use devices designed to aid in the surgical correction of several types of spinal conditions by providing stabilization until a solid spinal fusion develops. When used as a pedicle screw system, the Thorocolumbar Spinal System when used in constructs with screws or spinal bolts placed in the pedicle are intended only for: grades 3 or 4 spondylolisthesis at the fifth lumbar-first sacral vertebral (L5-S1) joint: who are receiving fusion using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of solid fusion. When used as a posterior hook and sacral/iliac screw fixation system only, the Thorocolumbar Spinal System is indicated for: Scoliotic, lordotic, or kyphotic deformities ddd ((defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) pseudarthrosis stenosis spondylolisthesis (grade 1 or 2) fracture tumor resection As a posterior system, it is limited to non-cervical posterior use with the levels of posterior screw fixation from L3-S1. As an anterolateral spinal system the indications are for anterior stabilization of levels T10 to L5 of the spine following: degenerative disc disease (defined above), tumor resection, spondylolisthesis, spondylolysis, fracture, pseudoarthrosis, and multi-operated back; and to correct lordotic and kyphotic spinal deformities. The levels of anterolateral use are T10-LS5.

Source page: https://510kreport.com/device/K965224
Methodology: https://510kreport.com/methodology