← Product Code [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP) · K965224 # EMPOWER ANTERIOR DIRECT SCREWS (K965224) _Smith & Nephew Richards, Inc. · KWP · May 8, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K965224 ## Device Facts - **Applicant:** Smith & Nephew Richards, Inc. - **Product Code:** [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP.md) - **Decision Date:** May 8, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3050 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended 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-L5. ## Device Story Thorocolumbar Spinal System; single-use orthopedic implants; provides stabilization for spinal fusion. Components include pedicle screws, spinal bolts, and posterior hooks. Used by surgeons in clinical/OR settings for spinal deformity correction and stabilization following trauma or degenerative conditions. System provides mechanical support to spine until solid fusion occurs. Pedicle screw constructs require removal after fusion. Anterolateral system stabilizes T10-L5; posterior system stabilizes L3-S1. Benefits include structural support for spinal healing. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Single-use spinal fixation system; components include pedicle screws, spinal bolts, and hooks. Designed for non-cervical posterior (L3-S1) and anterolateral (T10-L5) spinal stabilization. Mechanical fixation device. ## Regulatory Identification A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} MAY - 8, 1997 Attachment 7 REVISED 510(K) SUMMARY K96 5224 Summary of Safety and Effectiveness Thorocolumbar Spinal System 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-L5. Testing of the Thorocolumbar Spinal System included comparison to substantially equivalent devices. The testing results were acceptable and the components should perform as well as comparable systems in clinical usage. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K965224](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K965224) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com