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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) decenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) lyphosis, (6) spinal tumor, 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: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-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 (L3 and below); and (d) 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 pattent history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scollosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) fulled previous fusion.

When used as an anterolateral thoracio/lumbar system, the DYNALOK CLASSIC™ Spinel System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogonic origin with degeneration of the dise 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 @ Spiral System, CD HORIZON ® Spinal System, and TENOR™ Spinal System.

DYNALOK CLASSIC"M Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium alloy described by such standards as ASTM F136 of ISO 5832-3. Never use stainless steel and titanium implant components in the same construct.

The provided text describes the DYNA-LOK CLASSIC™ Spinal System and its 510(k) summary for FDA clearance. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

• Description of the device: Components and materials.
• Indications for Use: Detailed descriptions of patient conditions for which the device is intended.
• Regulatory Clearance: FDA's substantial equivalence determination to predicate devices.
• Risk Analysis: A statement that a risk analysis was performed.

There is no mention of the following:

1. Acceptance criteria table or reported device performance.
2. Sample size for test sets or data provenance. (There are no test sets described.)
3. Number or qualifications of experts for ground truth. (No ground truth establishment is described.)
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance. (This is a physical device, not an algorithm.)
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory submission for a physical medical device, not a software or AI-based device, and therefore the concepts of "test set," "training set," "ground truth," "MRMC studies," or "algorithm performance" do not apply in the context of this specific 510(k) summary. The "Functionality & Safety Testing" section only states that a Risk Analysis was performed; it does not detail any specific performance testing or acceptance criteria.

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