COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM

K955365 · Sofamor Danek USA,Inc. · KWP · Mar 27, 1996 · Orthopedic

Device Facts

• Record ID: K955365
• Device Name: COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
• Applicant: Sofamor Danek USA,Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Mar 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The purpose of the CCD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CCD™ Spinal System is limited to non-cervical use in the posterior spine. The CCD spinal screws, when used as pedicle screws with the CCD™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (grade 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 for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and no lower than the sacrum. Otherwise, the CCD screws, when used in posterior fixation, are intended for sacral/iliac attachment only. Except for situations where stainless steel screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a CCD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CCD Spinal System (either stainless steel or titanium alloy versions) are the following: 1. Degenerative disc disease (as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and/or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule). 2. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, and lordosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection All of the CCD hooks are intended for posterior thoracic and/or lumbar use only. CCD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.

Device Story

CCD Spinal System provides posterior spinal stabilization to facilitate solid fusion; components include rods, hooks, screws, connectors, and cross connectors. Used in posterior thoracic, lumbar, and sacral spine; implanted by surgeons during spinal procedures. Stainless steel or titanium alloy components assembled into constructs; stainless steel and titanium must not be mixed. Provides mechanical support to stabilize vertebral segments during bone healing. Benefits include structural support for spinal pathologies; pedicle screws specifically indicated for severe L5-S1 spondylolisthesis with mandatory removal after fusion.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and mechanical testing.

Technological Characteristics

Materials: ASTM F138 stainless steel or ASTM F136 titanium alloy. Components: rods, hooks, screws, connectors, cross-connectors. Non-cervical, posterior spinal application. Sold sterile or non-sterile. Mechanical stabilization via rigid construct.

Indications for Use

Indicated for patients requiring posterior spinal stabilization for degenerative disc disease, pseudoarthrosis, stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fracture, failed fusion, or tumor resection. Pedicle screw use restricted to severe L5-S1 spondylolisthesis (Grade 3-4) with autogenous bone graft, L3-sacrum insertion, and mandatory removal post-fusion. Non-cervical use only.

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.

Submission Summary (Full Text)

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L955365

# Compact Cotrel-Dubousset (CCD™) Spinal System
## 510(k) Summary

K C 955365

I. Company: Sofamor Danek USA
1800 Pyramid Place
Memphis, TN 38132
901-396-3133

Mar 27

II. Proprietary Trade Name: Compact Cotrel-Dubousset (CCD™) Spinal System

Classification Name: Pedicle Screw Fixation - Spondylolisthesis spinal fixation device system. Otherwise, spinal interlaminal fixation orthosis.

III. The CCD™ Spinal System consists of rods, hooks, screws, connectors, cross connectors, and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CCD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CCD™ Spinal System implant components are fabricated either from ASTM F138 or its ISO equivalent stainless steel or titanium alloy conforming to ASTM F136 or its ISO equivalent (non-pedicle screw indications only) and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implant components in a spinal construct.

IV. The CCD™ Spinal System is limited to non-cervical use in the posterior spine. The CCD spinal screws, when used as pedicle screws with the CCD™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (grade 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 for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and no lower than the sacrum. Otherwise, the CCD screws, when used in posterior fixation, are intended for sacral/iliac attachment only. Except for situations where stainless steel screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a CCD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CCD Spinal System (either stainless steel or titanium alloy versions) are the following:

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1. Degenerative disc disease (as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and/or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule).
2. Pseudoarthrosis
3. Stenosis
4. Spondylolisthesis
5. Spinal deformities: scoliosis, kyphosis, and lordosis
6. Fracture
7. Unsuccessful previous attempts at spinal fusion
8. Tumor resection

All of the CCD hooks are intended for posterior thoracic and/or lumbar use only. CCD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.