(51 days)
The Karma® Fixation System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternom following sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.
The Karma® Fixation System is a temporary implant to be used in orthopedic surgery. The Karma® implant is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Karma® Fixation System is designed for a posterior approach. The include the following applications:
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Spinal trauma surgery: Karma® implants can be used in sublaminar wiring techniques;
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Spinal degenerative surgery: Karma® implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.
The Karma® Fixation System consists of a strap manufactured from PEEK conforming to ASTM F2026 compounded with 7.5% barium sulphate for radiopacity and Tantalum conforming to ASTM F560. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap through or around the bony structures to be secured. Both the spherical tip and the head of the device contain a tantalum pin for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taught by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.
This document is an FDA 510(k) summary for a medical device called the Karma® Fixation System. It explicitly states: "No additional testing was performed in support for this 510(k) Premarket Notification. An engineering rationale was provided to demonstrate substantial equivalence when compared to the predicate device."
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in this document. The device's clearance is based on substantial equivalence to a predicate device (K180728) through an engineering rationale, rather than new performance testing.
§ 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.