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K Number
K962708
Device Name
TITANIUM CD HORIZON SPINAL SYSTEM
Manufacturer
SOFAMOR DANEK USA,INC.
Date Cleared
1997-02-06

(209 days)

Product Code
KWP
Regulation Number
888.3050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Titanium CD HORIZON" Spinal System, when using screws for pedicle fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 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 secral spine; and (d) who are having the device removed after the development of a solid fusion mass. Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a Titanium CD HORIZON™ construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the Titanium CD HORIZON™ Spinal System are the following: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). 2. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, lordosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection NOTA BENE: The Titanium CD HORIZON" Spinal System Is limited to noncervical use. The titanium alloy CD HORIZON" screws and the titanium alloy TSRH® Variable Angle Scrows, when used as pedicle screws with the Titanium CD HORIZON™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (Grades 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 not lower than the sacrum. Otherwise the tifanium alloy CD HORIZON" screws and the titanium alloy TSRH® Variable Angle Screws, when used with the Titanium CD HORIZON® Spinal System, are intended for sacral/iliac attachment only. All of the titanium alloy CD HORIZON" hooks are intended for thoracic and/or lumber attachment only. The titanium alloy TSRH® Low Profile CROSSLINK® Officet Plate, the titanium alloy TSRH® Low Profile CROSSLINK® plates, and the titanium alloy CD HORIZON™ Low Profile MULTI-SPAN" CROSSLINK® plates are intended for posterior thoracic, lumbar, and/or sacral use only.
Device Description
The Titanium CD HORIZON™ Spinal System consists of the following implant components which can be assembled in a variety of configurations, with each resulting spinal implant construct being tailor-made for the individual case. CD HORIZON® rod (commercially pure titanium), 8.35mm diameter CD HORIZON™ knurled rod (titanium alloy), 6.35mm diameter CD HORIZON™ hooks (titanium alloy) CD HORIZON™ screws (titanium alloy): 5.5mm, and 7.5mm diameters CD HORIZON™ Break-Off Set Screw (titanium alloy) CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates (titanium alloy) In addition, the following Titanium TSRH® Spinal system implants can be used with the Titanium CD HORIZON™ Spinal System. TSRH® rod (titanium alloy), 6.35mm diameter TSRH® Variable Angle Screws (titanium alloy): 6.5mm and 7.5mm diameters TSRH® Top Tightening Variable Angle T-Botts with Locking Screw (titanium alloy): small, medium, and large TSRH® Low Profile CROSSLINK® Offset Plate (titanium alloy) TSRH® Low Profile CROSSLINK® Plates (titanium alloy) TSRH® Low Profile CROSSLINK® Plate Set Screws (titanium alloy) The Titanium CD HORIZON™ Spinal System components and the others mentioned above are made out of titanium alloy described by ASTM Standard F136 or its ISO equivalent. The Titanium CD HORIZON" Spinal System also features a rod fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. Titanium CD HORIZON™ implant components must not be used with implant components fabricated from stainless steel or any other alloy in a construct. The Titanium CD HORIZON™ implants may be sold sterile or nonsterile. Instruments are available to facilitate the use of the device.
More Information

This section is marked as "Not Found" in the provided text. Therefore, there are no K/DEN numbers to list.

Not Found

No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.

Yes
The device is a spinal system intended for various spinal conditions, including degenerative disc disease, spondylolisthesis, and fractures, which are medical conditions that require treatment.

No

The "Intended Use / Indications for Use" and "Device Description" sections clearly state that this device is a spinal system (implants like rods, screws, and plates) used for spinal fusion and stabilization, not for diagnosing conditions.

No

The device description explicitly lists various physical implant components made of titanium alloy, such as rods, hooks, and screws, which are hardware.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
  • Device Description and Intended Use: The description and intended use clearly indicate that the Titanium CD HORIZON™ Spinal System is a surgical implant used to stabilize and fuse sections of the spine. It is a physical device implanted into the body, not used for testing samples outside the body.

The text describes a spinal implant system used for surgical procedures, which falls under the category of implantable medical devices, not IVDs.

N/A

Intended Use / Indications for Use

The Titanium CD HORIZON" Spinal System, when using screws for pedicle fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 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 secral spine; and (d) who are having the device removed after the development of a solid fusion mass.

Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a Titanium CD HORIZON™ construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the Titanium CD HORIZON™ Spinal System are the following:

    1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
    1. Pseudoarthrosis
    1. Stenosis
    1. Spondylolisthesis
    1. Spinal deformities: scoliosis, kyphosis, lordosis
    1. Fracture
    1. Unsuccessful previous attempts at spinal fusion
    1. Tumor resection

NOTA BENE: The Titanium CD HORIZON" Spinal System Is limited to noncervical use. The titanium alloy CD HORIZON" screws and the titanium alloy TSRH® Variable Angle Scrows, when used as pedicle screws with the Titanium CD HORIZON™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (Grades 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 not lower than the sacrum. Otherwise the tifanium alloy CD HORIZON" screws and the titanium alloy TSRH® Variable Angle Screws, when used with the Titanium CD HORIZON® Spinal System, are intended for sacral/iliac attachment only. All of the titanium alloy CD HORIZON" hooks are intended for thoracic and/or lumber attachment only. The titanium alloy TSRH® Low Profile CROSSLINK® Officet Plate, the titanium alloy TSRH® Low Profile CROSSLINK® plates, and the titanium alloy CD HORIZON™ Low Profile MULTI-SPAN" CROSSLINK® plates are intended for posterior thoracic, lumbar, and/or sacral use only.

Product codes

Not Found

Device Description

The Titanium CD HORIZON™ Spinal System consists of the following implant ============================================================================================================================================================================== The Themich of TONE online of the a variety of configurations, with each resulting spinal implant construct being tailor-made for the individual case.

  • CD HORIZON® rod (commercially pure titanium), 8.35mm diameter ●
  • CD HORIZON™ knurled rod (titanium alloy), 6.35mm diameter ●
  • CD HORIZON™ hooks (titanium alloy) .
  • CD HORIZON™ screws (titanium alloy): 5.5mm, and 7.5mm diameters .
  • CD HORIZON™ Break-Off Set Screw (titanium alloy) .
  • CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates (titanium alloy) .

In addition, the following Titanium TSRH® Spinal system implants can be used with the Titanium CD HORIZON™ Spinal System.

  • TSRH® rod (titanium alloy), 6.35mm diameter .
  • TSRH® Variable Angle Screws (titanium alloy): 6.5mm and 7.5mm diameters .
  • TSRH® Top Tightening Variable Angle T-Botts with Locking Screw (titanium alloy): . small, medium, and large
  • TSRH® Low Profile CROSSLINK® Offset Plate (titanium alloy) ●
  • TSRH® Low Profile CROSSLINK® Plates (titanium alloy) ●
  • TSRH® Low Profile CROSSLINK® Plate Set Screws (titanium alloy) .

The Titanium CD HORIZON™ Spinal System components and the others mentioned above are made out of titanium alloy described by ASTM Standard F136 or its ISO equivalent. The Titanium CD HORIZON" Spinal System also features a rod fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. Titanium CD HORIZON™ implant components must not be used with implant components fabricated from stainless steel or any other alloy in a construct. The Titanium CD HORIZON™ implants may be sold sterile or nonsterile.

Instruments are available to facilitate the use of the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Lumbar and sacral spine, L5-S1 vertebral joint, noncervical, thoracic

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Mechanical test data were provided in the application.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
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.(b)
Classification. Class II.

0

Titanium CD HORIZON™ Spinal System 510(k) Summary K962708 February, 1997

FEB - 6 1997

K962708

  • Sofamor Danek USA 1. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
  • Proposed Proprietary Trade Name: Titanium CD HORIZON™ Spinal System 11.
  • The Titanium CD HORIZON™ Spinal System consists of the following implant ============================================================================================================================================================================== The Themich of TONE online of the a variety of configurations, with each resulting spinal implant construct being tailor-made for the individual case.
  • CD HORIZON® rod (commercially pure titanium), 8.35mm diameter ●
  • CD HORIZON™ knurled rod (titanium alloy), 6.35mm diameter ●
  • CD HORIZON™ hooks (titanium alloy) .
  • CD HORIZON™ screws (titanium alloy): 5.5mm, and 7.5mm diameters .
  • CD HORIZON™ Break-Off Set Screw (titanium alloy) .
  • CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates (titanium alloy) .

In addition, the following Titanium TSRH® Spinal system implants can be used with the Titanium CD HORIZON™ Spinal System.

  • TSRH® rod (titanium alloy), 6.35mm diameter .
  • TSRH® Variable Angle Screws (titanium alloy): 6.5mm and 7.5mm diameters .
  • TSRH® Top Tightening Variable Angle T-Botts with Locking Screw (titanium alloy): . small, medium, and large
  • TSRH® Low Profile CROSSLINK® Offset Plate (titanium alloy) ●
  • TSRH® Low Profile CROSSLINK® Plates (titanium alloy) ●
  • TSRH® Low Profile CROSSLINK® Plate Set Screws (titanium alloy) .

The Titanium CD HORIZON™ Spinal System components and the others mentioned above are made out of titanium alloy described by ASTM Standard F136 or its ISO equivalent. The Titanium CD HORIZON" Spinal System also features a rod fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. Titanium CD HORIZON™ implant components must not be used with implant components fabricated from stainless steel or any other alloy in a construct. The Titanium CD HORIZON™ implants may be sold sterile or nonsterile.

Instruments are available to facilitate the use of the device.

1

The Titanium CD HORIZON" Spinal System, when using screws for pedicle fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 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 secral spine; and (d) who are having the device removed after the development of a solid fusion mass.

Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a Titanium CD HORIZON™ construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the Titanium CD HORIZON™ Spinal System are the following:

    1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
    1. Pseudoarthrosis
    1. Stenosis
    1. Spondylolisthesis
    1. Spinal deformities: scoliosis, kyphosis, lordosis
    1. Fracture
    1. Unsuccessful previous attempts at spinal fusion
    1. Tumor resection

NOTA BENE: The Titanium CD HORIZON" Spinal System Is limited to noncervical use. The titanium alloy CD HORIZON" screws and the titanium alloy TSRH® Variable Angle Scrows, when used as pedicle screws with the Titanium CD HORIZON™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (Grades 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 not lower than the sacrum. Otherwise the tifanium alloy CD HORIZON" screws and the titanium alloy TSRH® Variable Angle Screws, when used with the Titanium CD HORIZON® Spinal System, are intended for sacral/iliac attachment only. All of the titanium alloy CD HORIZON" hooks are intended for thoracic and/or lumber attachment only. The titanium alloy TSRH® Low Profile CROSSLINK® Officet Plate, the titanium alloy TSRH® Low Profile CROSSLINK® plates, and the titanium alloy CD HORIZON™ Low Profile MULTI-SPAN" CROSSLINK® plates are intended for posterior thoracic, lumbar, and/or sacral use only.

  • V. The Titanium CD HORIZON™ Spinal System was declared substantially equivalent to other predicate or preamendments devices. Mechanical test data were provided in the application.
    @1997 Sofamor Danek