(101 days)
The SCARF THREAD-HEAD™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions. The SCARF THREAD-HEAD™ SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
The SCARF THREAD-HEAD™ SCREW is a cannulated thread-head screw made of a Titanium alloy. Screws come in lengths of 10-32 mm in 2 mm increments.
This document describes a medical device, the SCARF THREAD-HEAD™ SCREW, and its intended use. It does not contain the information requested about acceptance criteria, device performance, studies involving AI, or ground truth establishment for a training set. The provided text is a summary of safety and effectiveness for a bone fixation screw and focuses on its description, intended use, and comparison to predicate devices, along with a single mechanical test.
Therefore, I cannot populate the table or answer the questions based on the provided text. The document is about a physical medical device, not an AI or software-based device that would typically have the kind of performance metrics and study details you've requested.
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Image /page/0/Picture/0 description: The image contains the logo for Landos Inc., which includes a stylized letter L inside of a circle. Below the company name, it states "A SUBSIDIARY OF GROUP LANDANGER CAMUS". The image also contains the number 962236.
SUMMARY OF SAFETY AND EFFECTIVENESS 3.
MANUFACTURER IDENTIFICATION:
Medinov - AMP Z.I. Bapaume 27-31 rue Lucien Langénieux 42335 Roanne Cedex FRANCE
LANDOS INC. Mr. Jean-Paul Burtin 100 Lindenwood Drive Malvern, PA 19355
ESTABLISHMENT REGISTRATION NUMBER:
SPONSOR IDENTIFICATION
OFFICIAL CONTACT PERSON:
2530066
Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854
Tel. : (301) 279 -2899 Fax : (301) 294-0126
May 22, 1996
DATE OF PREPARATION OF THIS SUMMARY :
TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME AND REFERENCE:
PROPOSED REGULATORY CLASS:
DEVICE PRODUCT CODE:
Bone Fixation Screw
SCARF THREAD-HEAD™ SCREW
Screw, Fixation, Bone (21 CFR, Section 888.3040) Class II
87HWC
PANEL CODE:
870R
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DESCRIPTION OF DEVICE:
INTENDED USE:
INDICATIONS FOR USE:
PREDICATE DEVICE:
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
SUMMARY OF STUDIES:
The SCARF THREAD-HEAD™
SCREW is a cannulated thread-head screw made of a Titanium alloy. Screws come in lengths of 10-32 mm in 2 mm increments.
The SCARF THREAD-HEAD™
SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions.
The SCARF THREAD-HEAD™
SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
The SCARF THREAD-HEAD™
SCREW is substantially equivalent to the Medinov-AMP Scarf Screw (K931155), the Herbert-Whipple Bone Screw (Zimmer) (K792022) and the M3 Screw System (Osteomed) (K924018, 924138).
Both the SCARF THREAD-HEAD™
SCREW, the Scarf Screw and the Herbert-Whipple Bone Screw have the same intended use and all are indicated for fixing small fractures or osteotomies. All are made from Titanium alloys. The SCARF THREAD-HEAD™ SCREW and Scarf Screws are threaded on nearly all their length with the same thread pitch. Both have a thread head and a hexagonal socket. The Scarf screw is not cannulated; the Herbert-Whipple screw is cannulated and is topped with a hexagonal socket.
Rupture torque of the SCARF THREAD-HEAD™ SCREW was compared with requirements of the French Standard Nº NF-F-90-414 and found to have a resistance to torsion in compliance with the selected Standard.
§ 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.