(28 days)
The NANO™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.
The ConMed Linvatec NANO™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of medical-grade PEEK and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is non-absorbable and is available in two sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor. The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for single use and is removed at the end of the repair leaving behind the suture anchor construct. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional surgical instruments, including drill bits, guides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.
The provided text describes a medical device submission (K112965) for the NANO™ Suture Anchor, a non-absorbable suture anchor system. The submission focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design, materials, and intended use.
However, the provided document does not contain the requested information regarding acceptance criteria, specific study results, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established. The document generally states that "The verification and validation testing of the NANO™ Suture Anchor includes fixation strength, cyclic loading, insertion, driver strength, biocompatibility, sterilization, shelf-life, packaging/transportation and comparator testing qualifications." but does not provide any detailed results or methodologies for these tests.
Therefore, I cannot fulfill your request for the specific comparative data and study details as they are not present in the provided text.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.