(101 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of a bone screw, with no mention of AI or ML.
Yes
The device is intended for fixation of bone fractures or bone reconstructions, which is a therapeutic purpose.
No
The device is a screw intended for fixing bone fractures or reconstructions, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "cannulated thread-head screw made of a Titanium alloy," which is a physical hardware implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone fractures or bone reconstructions and fixing elective osteotomies in the foot. This is a surgical implant used directly on the patient's body.
- Device Description: The device is a cannulated thread-head screw made of a titanium alloy. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not implanted within the body for structural support or fixation.
N/A
Intended Use / Indications for Use
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.
Product codes
87HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-foot bones and the metatarsal and phalanges of the foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K931155, K792022, K924018, 924138
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.