(72 days)
Not Found
No
The device description and intended use clearly describe a mechanical fixation system (screws, wires, pins) and associated tools, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is used for fixation of bone fractures and fusion of joints or bone reconstructions, which are considered mechanical support or reconstruction functionalities rather than therapeutic.
No
Explanation: The device is described as an implant system for fixation of bone fractures, fusion of joints, or bone reconstructions, and not for diagnosing medical conditions.
No
The device description clearly states it is a "family of threaded external fixator" and lists physical components like screws, wires, pins, and accessory devices. This indicates it is a hardware-based medical device.
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, fusion of joints or bone reconstructions or as guide pins for insertion of other implants." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details physical implants like screws, wires, and pins made of stainless steel, along with surgical accessories like depth gauges and drill bits. These are all physical devices used in a surgical procedure.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device described is a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Newfix® Screw, Wire and Pin Fixation System is intended to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.
Product codes
HWC
Device Description
The Newfix® Screw, Wire and Pin Fixation System is a family of threaded external fixator of various sizes for use in the treatment of fractures. Pins include smooth and self drilling/self-tapping type threaded pin with diamond tip and cutting edges. The pin and screws of the Newfix System are manufactured using implant grade stainless steel. Pin configurations include Kirschner Pins (K-wires), Schanz Screws, Steinmann Pin and Conic Threaded Bone Screws all in various lengths, diameters and threads. The Newfix® Screw, Wire and Pin Fixation System is intended for single patient use. None of the components of the Newfix System are reusable. The Newfix® Screw, Wire and Pin Fixation System includes the following accessory devices: Depth Gauge; Tissue Protection Triple Guide for Axial Fixation; T Shape Handle Chuck; and Drill Bits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, joints
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K101254 (1/3)
Tecnología y Diseño Industrial, S.A. de C.V. Newfix Screw, Wire and Pin Fixation System Summary of Safety and Effectiveness
SUMMARY OF SAFETY AND EFFECTIVENESS
July 13, 2010
Trade Name: Newfix Screw, Wire and Pin Fixation System
Common Name: Screw, Fixation, Bone
JUL 1 5 2010
Applicant:
,
Tecnología y Diseño Industrial, S.A. de C.V. José Adán Ortega Torres Operation Manager
José Guadalupe Zuno 48 Col. Parque Industrial los Belenes Zapopan, Jalisco Mexico, C.P. 45101
Tel: +52 (33) 38 36 45 00 Ext. 2960 +52 (33) 36245132 Fax: +52 (33) 38 36 45 02
Classification Name: Smooth or threaded metallic bone fixation fastener Classification Panel: Orthopedic
All questions and/or comments concerning this document should be made to:
Robert J. Bard, Esq. Managing Director
HealthCare Technologies Consultants PO Box 506 South Lyon, MI 48178 Tel: 248-573-5040 Cell: 734-330-5990 email: rbard@reglaw.net
1
1.0 DEVICE SUMMARY
The Tecnologia y Diseño Industrial, S.A. de C.V. Newfix® Screw. Wire and Pin Fixation System of devices are a family of external fixation pins and screws for use in orthopedic treatment fractures.
- 1.1 Classification Information
Table SE1: Device Classification
| Classification or descriptor | Name or designation |
|---|---|
| Common Name | Smooth or threaded pin |
| Device Trade Name | Newfix Screw, Wire and Pin Fixation System |
| Device Classification Name | Smooth or threaded metallic bone fixation fastener |
| Device Classification | Class II |
| Reviewing Panel | Orthopedic |
| Regulation Number | 21 CFR 880.3040 |
| Product Code | HWC |
2.0 PREDICATE DEVICES
The Newfix Screw systems are substantially equivalent to the following predicate products.
- 2.1 Treu-Instrumente GmbH Bone Fixation Screws and Pins
2.1.1 510(k) Number: K083912
3.0 INTENDED USE AND INDICATIONS FOR USE
The Newfix® Screw, Wire and Pin Fixation System is intended to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.
DEVICE DESCRIPTIONS 4.0
- 4.1 The Newfix® Screw, Wire and Pin Fixation System is a family of threaded external fixator of various sizes for use in the treatment of fractures.
- 4.2 Pins include smooth and self drilling/self-tapping type threaded pin with diamond tip and cutting edges.
- 4.3 The pin and screws of the Newfix System are manufactured using implant grade stainless steel.
- 4.4 Pin configurations include Kirschner Pins (K-wires), Schanz Screws, Steinmann Pin and Conic Threaded Bone Screws all in various lengths, diameters and threads.
| 4.4.1 | Dimensional specifications | |
|---|---|---|
| ------- | -- | ---------------------------- |
- Table SE2: Dimensional specs
| Pin Type | Diameter (Ø) | Length |
|---|---|---|
| Kirschner pin (K-wire) | Ø 1.6 – 2.5 mm | 100 – 400 mm |
| Schanz screw | Ø 2.5 - 6 mm | 60 - 250 mm |
2
K101254 (3/2)
Tecnología y Diseño Industrial, S.A. de C.V. Newfix Screw, Wire and Pin Fixation System Summary of Safety and Effectiveness
| Steinmann pin | Ø 3.5 – 5 mm | 150 - 250 mm |
|---|---|---|
| Conic pin | Ø 4-3.0/2.5 – 6/5 mm | 60 - 220 mm |
- 4.5 The Newfix® Screw, Wire and Pin Fixation System is intended for single patient use. None of the components of the Newfix System are reusable.
- 4.6 The Newfix® Screw, Wire and Pin Fixation System includes the following accessory devices: Depth Gauge; Tissue Protection Triple Guide for Axial Fixation; T Shape Handle Chuck; and Drill Bits.
5.0 COMPARISON OF DEVICE UNDER REVIEW AND ITS PREDICATES
- 5.1 Comparison of Devices
| Comparison
Element | TDI Newfix® Screw, Wire and Pin
Fixation System | TREU-INSTRUMENTE GmbH
Bone Fixation Screws and Pins |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Tecnologia y Diseño Industrial, S.A.
de C.V. | TREU-INSTRUMENTE GmbH |
| Indication for/
Intended Use | The Newfix® Screw, Wire and Pin
Fixation System is intended to be
used as implants for the fixation of
bone fractures, fusion of joints or
bone reconstructions or as guide
pins for insertion of other implants. | The Treu Bone Fixation Screws
and Pins are intended to be
used as implants for the fixation
of bone fractures, fusion of joints
or bone reconstructions or as
guide pins for insertion of other
implants. |
| Materials | Stainless Steel 316 LS/LVM Implant
Grade. | Titanium and stainless steel
(ISO 58/32-1) |
| Duration of Use | Greater than 30 days | Greater than 30 days |
| Reuse Capability | Single use | Single use |
| Fixation | Pins/Screws | Pins/Screws |
| Sterility | Non-sterile (to be sterilized prior to
use) | Non-sterile (to be sterilized prior
to use) |
3
Image /page/3/Picture/11 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an abstract image of an eagle. The eagle is facing to the right and has three stripes on its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Technología y Diseño Industrial SA DE CV % Mr. Robert J. Bard, JD P.O. Box 506 South Lyon, Michigan 48178
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUL 1 5 2010
Re: K101254
Trade/Device Name: Newfix Screw, Wire and Pin Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 29, 2010 Received: May 4, 2010
Dear Mr. Bard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2- Mr. Robert J. Bard, JD
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
4
.s.
Enclosure
5
Indication for Use
JUL 1 5 2010
510(k): K101254
Device Name: Newfix Screw, Wire and Pin Fixation System
Indication for Use: The Newfix Screw, Wire and Pin Fixation System is to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.
Prescription Use X (21 CFR Part 801 Subpart D)
"。
AND/OR
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jonetu for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101254