(30 days)
Arthrex Small External Fixation System is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where soft tissue injury may preclude the use of other fracture treatments. The Arthrex Small External Fixation System is intended to be non-weight bearing.
The Arthrex Small External Fixation System is an external fixation device comprised of rods, clamps, and threaded half pins used for the management of bone fractures and reconstructive orthopedic surgery. The Arthrex Small External Fixation System is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of titanium (Ti-6Al-4V ELI conforming to ASTM F136), stainless steel (316L and 304 conforming to ASTM F138 and A276), and Aluminum (6061-T6 conforming to ASTM B211) clamps (pin-to-rod and multi-pin); stainless steel (316L conforming to ASTM F138) threaded half pins; and carbon fiber connector rods. The Arthrex Small External Fixation System is manufactured with threaded half pins and rods of 5.0 mm shaft diameter, which allows for support with small, long bone or short bone fractures. The Arthrex Small External Fixation System is a singleuse, non-sterile device intended for end-user sterilization. The Arthrex Small External Fixation System is manufactured with pins and rods of 5.0 mm shaft diameter, which allows for connectivity for support of bone fractures. The pin-to-rod clamps are designed to clamp the 5.0 mm carbon fiber rods to the 2.0 mm and 3.0 mm stainless steel threaded half pins, or other rods. The multi-pin clamps are designed to attach to other external fixator pieces to build constructs for a variety of fracture types and allows for angulated pin insertion. The stainless steel threaded pins come in 2.0 mm and 3.0 mm in diameter, and in total lengths of 55 mm, 75 mm, 100 mm, or 140 mm. The thread lengths come in 10 mm, 15 mm, 20 mm, and 25 mm. The threaded pins have twist flutes so that they are self-drilling and selftapping. The stainless steel Drill Guide Pins are supplied in 1.5 mm diameter. The connecting rods are carbon fiber with an overall diameter of 5.0 mm and are in lengths of 50 mm, 75 mm, 100 mm, 125 mm, 150 mm, 200 mm, 250 mm, and 300 mm.
This document (K232897) is an FDA 510(k) clearance for the Arthrex Small External Fixation System. It explicitly states that the device is substantially equivalent to a previously cleared predicate device (AOS Small External Fixation System, K141912).
Crucially, this document confirms that no new testing or studies were conducted for this 510(k) submission. The basis for clearance is that the device design, materials, and intended use are identical to the predicate device, and therefore, the performance data from the predicate device is considered sufficient.
Therefore, I cannot provide the requested information about acceptance criteria, specific performance results, sample sizes, expert ground truth establishment, or multi-reader studies for this specific submission (K232897) because no such studies were performed or submitted.
The relevant section from the document that supports this is titled "Performance Data" on page 5, which states:
- "The Arthrex Small External Fixation System has the same intended use and fundamental technology as the predicate device cleared, K141912."
- "The device is the same design as the predicate device. No design modifications were made to the Arthrex Small External Fixation System and the transition from AOS to Arthrex do not present a new worst case."
- "Therefore, the mechanical testing conducted for the predicate devices still represents worst case testing and additional verification testing are not required for the devices."
- "There has been no change in the device materials or manufacturing materials/process..."
- "...no new biocompatibility testing has been provided."
In summary, the "study" proving the device meets acceptance criteria for K232897 is the previous clearance (K141912), as this submission relied on the substantial equivalence principle rather than new performance testing.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.