Who is the manufacturer of EMPOWER ANTERIOR DIRECT SCREWS?

Smith & Nephew Richards, Inc. filed the 510(k) submission for EMPOWER ANTERIOR DIRECT SCREWS (K965224).

What is the FDA product code for EMPOWER ANTERIOR DIRECT SCREWS?

KWP. It is classified under 21 CFR 888.3050 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for EMPOWER ANTERIOR DIRECT SCREWS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EMPOWER ANTERIOR DIRECT SCREWS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EMPOWER ANTERIOR DIRECT SCREWS

K965224 · Smith & Nephew Richards, Inc. · KWP · May 8, 1997 · Orthopedic

Device Facts

Record ID	K965224
Device Name	EMPOWER ANTERIOR DIRECT SCREWS
Applicant	Smith & Nephew Richards, Inc.
Product Code	KWP · Orthopedic
Decision Date	May 8, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3050
Device Class	Class 2
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.

Indications for Use

Indicated for patients requiring spinal stabilization for scoliotic, lordotic, or kyphotic deformities, degenerative disc disease, pseudarthrosis, stenosis, spondylolisthesis (grades 1-4), fractures, tumor resection, spondylolysis, and multi-operated back. Specific use cases: pedicle screw fixation (L5-S1, grades 3-4 spondylolisthesis, autogenous bone graft required, removal after fusion); posterior hook/screw fixation (non-cervical, L3-S1); anterolateral stabilization (T10-L5).

Regulatory Classification

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.

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K102458 — 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM · Solco Biomedical Co., Ltd. · Jun 13, 2011
K141147 — RANGE SPINAL SYSTEM · K2m, Inc. · Jun 3, 2014

Submission Summary (Full Text)

{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.