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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNALOK CLASSIC™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNALOK CLASSIC™ Spinal System is indicated for skeletally mature patients: {1} having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (13 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNALOK CLASSIC™ Spinal System is intended for the following indications: (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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kychosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. When used as an anterolateral thoracic/lumbar system, the DYNALOK CLASSIC™ Spinal System is intended for the following indications: (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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The DYNALOK CLASSIC™ Spinal System consists of a variety of shapes and sizes of plates, bolts, screws, washers, nuts, spacers, CROSSLINK® Plates, and connecting components. The DYNALOK CLASSIC™ Spinal System components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Additionally, the DYNALOK CLASSIC™ Spinal System may be used in conjunction with TSRH ® Spinal System, CD HORIZON ® Spinal System, and TENOR™ Spinal System.

DYNALOK CLASSIC™ Spinal System implant components are fabricated from medical grade stainless steel. Alternatively, the entire system may be made out of medical grade titanium alloy. Never use stainless steel and titanium implant components in the same construct.

To achieve best results and unless stated otherwise in another Medtronic Sofamor Danek document, do not use any of the DYNALOK CLASSIC™ Spinal System components with the components from any other system. (NOTE: In addition to the DYNALOK CLASSIC™ rod bolt connectors and bolts, a surgeon may want to connect a spinal rod to CD HORIZON® hooks. The hooks would be applied as stated in the CD HORIZON® Spinal System package insert. However, instead of using the fixed angle CD HORIZON® bone screws or multi axial screws, the DYNALOK CLASSIC™ rod bolt connector and bolt would be substituted in their place. Hooks may only be used posteriorly and provided that the metal alloys are compatible.)

The purpose of this submission is to include an alternative minimally invasive surgical technique to the system.

The provided text is a 510(k) summary for the DYNALOK CLASSIC™ Spinal System. It details the device's description, indications for use, and a declaration of substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, this is a regulatory filing focused on demonstrating equivalence to an already approved device for an additional surgical technique. It does not include:

• Acceptance Criteria or Device Performance Table: No such table is present.
• Sample Size or Data Provenance for Test Set: No specific test set data is mentioned. The submission is based on the premise that no new or modified components are added, and thus no new risks are posed by the alternative surgical technique.
• Number of Experts/Qualifications for Ground Truth: No expert review or ground truth establishment is described.
• Adjudication Method: Not applicable as no ground truth establishment is detailed.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned or implied, as this is a device modification submission, not an AI or diagnostic tool.
• Standalone Performance Study: No algorithm-only study is applicable or described.
• Type of Ground Truth Used: Not applicable, as the submission focuses on device equivalence, not diagnostic accuracy.
• Sample Size for Training Set & Ground Truth for Training Set: These are not relevant to this type of device submission and are not mentioned.

The core of this 510(k) summary is the statement: "No new components were added to the system, as the sole change is the addition of an alternative surgical technique that is left to the discretion of the surgeon. The proposed technique requires no new or modified components, nor does it pose any additional risks. Therefore, the subject submission is substantially equivalent to the predicate DYNALOK CLASSIC™ Spinal System." This indicates that the device's safety and effectiveness are deemed equivalent to an already approved device based on the lack of material change, rather than new testing against defined acceptance criteria.

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