(101 days)
The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine; hand, tibia; radius and calcaneus. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cernents that are legally marketed for use in vertebroplasty or kyphoplasty procedures.
The SKy System consists of the following components:
- Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
- Delivery system used for the insertion, expansion, and retrieval of the expandable tube.
- Instrumentation Set - a set of accessories to assist in insertion and location of the device.
I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the SKy Bone Expander System, outlining its intended use, description, and substantial equivalence to previously cleared devices. It does not include details about performance testing, sample sizes, ground truth establishment, or clinical studies.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.