(209 days)
The intended use of the Ascent Medical - PHIN-FX Cannulated Lag Screw System is to draw two or more aligned bone fragments together in an adult patient.
The Ascent Medical - PHIN-FX Cannulated Laq Screw System is indicated for use for small and long bone fractures, arthrodesis and osteotomy fixation as follows:
The Mini and Small - PHIN-FX Cannulated Lag Screw Systems are indicated for small bone fractures and reduction of the glenoid and humeral head, medial malleolus and fibula, distal tibia and pilon, radius and ulna, olecranon and distal humerus, patella, pelvis, tarsal and fusions, metatarsal and phalangeal and with osteotomies, small bones in the hand and wrist, ligament fixation when appropriate, small joint fusion, and other small bone fragment cancellous fractures and osteotomies where the size of the screw/washer adapts to the specific indication.
The Large - PHIN-FX Cannulated Lag Screw System is indicated for long bone fractures and reduction of the intracapsular hip, slipped capital femoral epiphysis with proper image fluoroscopy for proper screw placement, femoral condyles, tibia condyles, ankle arthrodesis, large bone calcaneus and talus, acetabulum, sacroiliac and pelvic disruptions, and other areas where accurate screw/washer placement in long bone is required and adapts to the specific indication.
The Ascent Medical - PHIN-FX Cannulated Lag Screw System is not for spinal use.
The Ascent Medical – PHIN-FX Cannulated Lag Screw System is a complement of various cannulated bone screws consisting of a 1). Mini Set of 2.0mm, 2.5mm, 3.0mm; 2). Small Set of 3.5mm, 4.0mm, 5.0mm; and 3). Large Set of 6.5mm and 7.3mm sizes with a Short or Long Thread length in numerous screw lengths to be used by the surgeon for various indications in the fracture fixation of small and long bone(s) in the human anatomy. All screws feature a cancellous thread form and are pre-drilling, self-tapping, and back-tapping (if removal is necessary) in design. All screws are used in conjunction with a appropriate sized Guide Wire and x-ray imaging for precise placement in bone across the fracture/osteotomy site. Associated matched size Washers for each screw size system are available for thin cortex or osteopenic bone where the screw head may break through. All Ascent Medical – PHIN-FX System cannulated bone screws & washers are manufactured from either high strength 316LVM Stainless Steel or 6-4 Alloyed Titanium materials. The titanium screws and washers are color anodized as a surface treatment for size recognition. A full compliment of instrumentation is available for use with the system. All implants and instrumentation are designated 'Non-sterile' in a tray/case system for 'single use' and sterilization by the end user.
This is a 510(k) premarket notification for a medical device (PHIN-FX Cannulated Lag Screw System), not a study evaluating a medical device's performance against specific acceptance criteria. Therefore, the requested information about acceptance criteria, study design, sample size, ground truth, and expert involvement for a device performance study is not present in this document.
The document states:
- "No nonclinical testing was used in the determination of substantial equivalence." This explicitly indicates that no performance studies (such as those that would involve acceptance criteria and reported device performance) were conducted or submitted for this 510(k) clearance.
- The determination of substantial equivalence was based on "Material, Design, and Indications" and an "engineering/dimensional comparison" to predicate devices.
Therefore, I cannot provide the information requested in your bullet points as it is not contained within this regulatory submission document.
§ 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.