(42 days)
The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/ Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal.
The fully threaded screws are manufactured from a Titanium alloy and are available in 5.0mm and 3.7mm diameters in lengths of 25 to 100mm.
The provided text describes a 510(k) summary for a medical device, the Alta® Fully Threaded Cross-Locking Screws. This document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for lower-risk medical devices. It does not contain information about acceptance criteria, device performance studies, or AI-related evaluations.
Therefore, I cannot provide the requested information as it is not present in the input text.
The input document is a 510(k) summary, which is a regulatory submission for medical devices to demonstrate substantial equivalence to a legally marketed predicate device. Such summaries typically do not include detailed performance studies with acceptance criteria, ground truth establishment, or AI-related metrics like those requested.
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1963398
OCT 10 1996 510(k) Summary
Proprietary Name: Alta® Fully Threaded Cross-Locking Screws
Common Name: Intramedullary Fixation Rod
Classification Name and Reference: 21 CFR 888.3020 Intramedullary Fixation Rod
Proposed Regulatory Class: Class II
Device Product Code: OR(87) HSB
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For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 8/29/96
The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/ Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal.
The fully threaded screws are manufactured from a Titanium alloy and are available in 5.0mm and 3.7mm diameters in lengths of 25 to 100mm.
The substantial equivalence of these screws is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Alta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K954554); Biomet's Uniflex Tibial Nail System and Retrograde Femoral Nail System; and Zimmer's ZMS Intramedullary Recon Nail.
§ 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.