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K Number
K955807
Device Name
COTREL-DUBOUSSET (CD) SPINAL
Manufacturer
SOFAMOR DANEK USA,INC.
Date Cleared
1996-10-01

(284 days)

Product Code
KWP
Regulation Number
888.3050
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K955807
Predicate For
K031595
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CD spinal screws, when used as pedicle screws with the CD™ 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. Otherwise, the CD 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 CD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CD Spinal System (either stainless steel or titanium alloy versions) are the following:

  1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies).
  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 CD hooks are intended for posterior thoracic and/or lumbar use only. CD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.
Device Description

The CDTM 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 CD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD™ Spinal System implant components are fabricated from ASTM F138 or its ISO equivalent stainless steel and may be sold sterile or non-sterile. Implant components made from different metal alloys must not be used together in a construct.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about a device that uses artificial intelligence or any study conducted to assess its performance against acceptance criteria. The document describes the Cotrel-Dubousset (CD™) Spinal System, which appears to be a medical implant system for spinal stabilization, not an AI-powered device.

Therefore, I cannot provide the requested table and details about acceptance criteria, study design, expert involvement, or AI-specific performance metrics as this information is not present in the given input.

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OCT ।

K955807

Cotrel-Dubousset (CD™) Spinal System 510(k) Summary

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

  • Proprietary Trade Name: Cotrel-Dubousset (CD™) Spinal System II.
    Pedicle Screw Fixation - Spondylolisthesis spinal Classification Name: fixation device system. Otherwise, spinal interlaminal fixation orthosis.

  • The CDTM Spinal System consists of rods, hooks, screws, connectors, cross III. 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 CD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD™ Spinal System implant components are fabricated from ASTM F138 or its ISO equivalent stainless steel and may be sold sterile or non-sterile. Implant components made from different metal alloys must not be used together in a construct.

  • The CD™ Spinal System is limited to non-cervical use in the posterior spine. IV. The CD spinal screws, when used as pedicle screws with the CD™ 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. Otherwise, the CD 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 CD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CD Spinal System (either stainless steel or titanium alloy versions) are the following:

    • Degenerative disc disease (as defined by back pain of discogenic origin with 1. degeneration of the disc confirmed by radiographic studies).
      1. Pseudoarthrosis

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    1. Stenosis
  • Spondylolisthesis 4.
  • Spinal deformities: scoliosis, kyphosis, and lordosis 5.
    1. Fracture
  • Unsuccessful previous attempts at spinal fusion 7.
  • Tumor resection 8.

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

© 1996 Sofamor Danek

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