(80 days)
The Universal Clamp Stainless Steel System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications:
- Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis,
- Spinal degenerative surgery, as an adjunct to spinal fusions;
The Universal Clamp Stainless Steel System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
The Universal Clamp Stainless Steel System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
This document describes the Abbott Spine Universal Clamp® Stainless Steel System. However, it does not include information about acceptance criteria or a study proving that the device meets specific performance criteria.
Instead, the document focuses on:
- Device Description: A temporary orthopedic implant for stabilization during bone fusion and fracture repair, used with other stainless steel implants for "wiring."
- Indications for Use: Spinal trauma, reconstructive, and degenerative surgery, and in conjunction with other stainless steel implants where wiring helps secure attachment.
- Substantial Equivalence: The primary basis for clearance is demonstrated through "Engineering evaluations and bench testing" which showed the Stainless Steel system is substantially equivalent to a previously cleared titanium alloy version (K060009).
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. The device's approval is based on substantial equivalence to a predicate device, supported by engineering evaluations and bench testing, rather than a clinical study with specific performance outcomes against acceptance criteria.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.