(114 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a bone screw, with no mention of AI or ML.
No
The device is a bone fixation appliance used for fractures and reconstructions, which falls under implantable surgical devices rather than therapeutic devices that treat a disease or condition.
No
Explanation: The device is a bone fixation appliance intended for implantation to fix bone fractures or reconstructions, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "threaded Titanium bone fixation appliance intended to be implanted," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of bone fractures or bone reconstructions" and is "intended to be implanted." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "threaded Titanium bone fixation appliance" that is "intended to be implanted." This further reinforces its nature as a surgical device.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform any such tests on samples.
The information provided describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The TWIST-OFF™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions. The TWIST-OFF™ SCREW is indicated for fixing and stabilizing elective osteotomies of metatarsals and phalanges of the foot.
Product codes
87HWC, 87OR
Device Description
The TWIST-OFF™ SCREW is a threaded Titanium bone fixation appliance intended to be implanted. It is composed of a self-tapping, selfcompressive screw and support as a single piece. These two components separate when the screw head comes in contact with the cortex. Screws come in lengths of 11,12,13 and 14 mm; the support does not vary in size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones, metatarsals 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 TWIST-OFF™ 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)
K924018, K924138, K950595, K952272
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
-3 1995
Image /page/0/Picture/2 description: The image shows the logo for Landos Inc. The logo consists of a stylized letter L inside of a circle on the left. To the right of the logo is the text "Landos Inc." in a stylized font. Below the company name is the text "A SUBSIDIARY OF GROUP LANDANGER O".
3. SUMMARY OF SAFETY AND EFFECTIVENESS
MANUFACTURER IDENTIFICATION:
Medinov - AMP Z.I. Bapaume 27-31 rue Lucien Langénieux 42335 Roanne Cedex FRANCE
SPONSOR IDENTIFICATION
LANDOS INC. Mr. Jean-Paul Burtin 100 Lindenwood Drive Malvern, PA 19355
2530066
ESTABLISHMENT REGISTRATION NUMBER:
OFFICIAL CONTACT PERSON:
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
DATE OF PREPARATION OF THIS SUMMARY:
May 22, 1996
TRADE NAME:
COMMON NAME:
TWIST-OFF™ SCREW
Bone Fixation Screw
CLASSIFICATION NAME AND REFERENCE:
Screw, Fixation, Bone (21 CFR, Section 888.3040)
PROPOSED REGULATORY CLASS:
Class II
000013
1
DEVICE PRODUCT CODE:
PANEL CODE:
DESCRIPTION OF DEVICE:
INTENDED USE:
INDICATIONS FOR USE:
PREDICATE DEVICE:
COMPARISON OF USES/ TECHNOLOGICAL CHARACTERISTICS:
SUMMARY OF STUDIES:
87HWC
87OR
The TWIST-OFF™ SCREW is a threaded Titanium bone fixation appliance intended to be implanted. It is composed of a self-tapping, selfcompressive screw and support as a single piece. These two components separate when the screw head comes in contact with the cortex. Screws come in lengths of 11,12,13 and 14 mm; the support does not vary in size.
The TWIST-OFF™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions.
The TWIST-OFF™ SCREW is indicated for fixing and stabilizing elective osteotomies of metatarsals and phalanges of the foot.
The TWIST-OFF™ SCREW is substantially equivalent to the M3 Screw system (Osteomed) (K924018, K924138), the Luhr Screw System (Howmedica)(K950595) and the Cortex Screw (Synthes)(K952272).
Both the TWIST-OFF™ SCREW and its predicates have the same intended use. All are used for fixation of small bones. The M3 and TWIST-OFFTM SCREW are made of the same Titanium alloy. The Cortex is made from a different Ti alloy; the Luhr Screw is made from Cobalt-Chromium. The M3 and the TWIST-OFFTM SCREW are partially threaded and are self-tapping low profile head screws. Both the M3 and the TWIST-OFFTM SCREW can be used with a power drill.
Rupture torque of the TWIST-OFF™ 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.