(306 days)
Not Found
No
The device description and performance studies focus on mechanical components and structural integrity, with no mention of AI or ML.
Yes.
The device is indicated for "stabilization of open and/or unstable fractures", which is a therapeutic purpose.
No
Explanation: The device is an external fixation system used for stabilization of fractures, not for diagnosing medical conditions. Its intended use is treatment, not diagnosis.
No
The device description explicitly details various hardware components such as clamps, distractors, pins, carbon fiber rods, and stainless steel tubes, indicating it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Newfix® External Fixation System is for the stabilization of fractures. This is a mechanical intervention on the body.
- Device Description: The device description details components like clamps, pins, and rods, which are used to physically fix bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Newfix® External Fixation System is used in vivo (inside the body) to treat fractures.
N/A
Intended Use / Indications for Use
The Newfix® External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Tecnología y Diseño Industrial, S.A. de C.V. Newfix® External Fixation System consists of various components including fixators, clamps, bars, distractors, carbon fiber rod, and stainless steel rods for use in orthopedic and trauma treatments.
The Newfix External Fixation System is a modular system that consists of various components including clamps, distractors, pins, carbon fiber rod, and stainless steel tubes for use in orthopedic and trauma treatment. The system is a modular design to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of aluminum and stainless steel clamps (rod-to-rod and pin-to-rod), stainless steel fixation pins and stainless steel and carbon fiber connector rods. Pins include smooth and self drilling/self-tapping type threaded pin with diamond tip and cutting edges. The Newfix® External Fixation System is supplied non sterile and is intended for single patient use. None of the components of the Newfix System are reusable. The Newfix® External Fixation System includes instruments and accessory devices necessary for its use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance tests were conducted to validate the locking mechanism of the Newfix External Fixation System against various components of the Orthofix predicate devices. Interconnection testing per ASTM F 1541 and engineering analysis comparing lock mechanisms demonstrated equivalence to predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K831576, K955848, K961350, K011034, K090658, K091258, K994143, K971755, K012294, K101254, K083912
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Tecnología y Diseño Industrial. S.A.P.I. de C.V Newfix® External Fixation System K101338 510(k) Summary
MAR 1 4 2011 SUMMARY OF SAFETY AND EFFECTIVENESS
March 11, 2010
Trade Name: Newfix® External Fixation System
Common Name: External Fixation System
Applicant:
Tecnología y Diseño Industrial, S.A.P.I. 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: Single/multiple component metallic bone fixation appliances and accessories
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
Tecnología y Diseño Industrial, S.A..P.I. de C.V. Newfix® External Fixation System K101338 510(k) Summary
1.0 DEVICE SUMMARY
The Tecnología y Diseño Industrial, S.A. de C.V. Newfix® External Fixation System consists of various components including fixators, clamps, bars, distractors, carbon fiber rod, and stainless steel rods for use in orthopedic and trauma treatments.
1.1 Classification Information
Table SE1: Device Classification
| Classification or descriptor | Name or designation |
|---|---|
| Common Name | External Fixation System |
| Device Trade Name | Newfix® External Fixation System |
| Device Classification Name | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Device Classification | Class II |
| Reviewing Panel | Orthopedic |
| Regulation Number | 21 CFR 880.3030 |
| Product Code | KTT |
2.0 PREDICATE DEVICES
The Newfix® External Fixation System is substantially equivalent to the following predicate products.
Table SE2: Predicate Products
| Manufacturer and Product | Cleared Predicate
Product |
|---------------------------------------------------------------------------------|------------------------------|
| Orthofix Modulsystem Dynamic Axial Fixation System | K831576, K955848 |
| Synthes ® External Fixation System | K961350, K011034,
K090658 |
| Extrafix External fixation System by QFX Technologies | K091258 |
| Smith & Nephew External Fixation System | K994143 |
| Hoffmann II Compact External Fixation System | K971755 |
| Zimmer Wristore Distal Radius Fracture Fixator | K012294 |
| Tecnología y Diseño Industrial (TDI) Newfix Screw, Wire, and
Fixation System | K101254 |
| Treu-Instrumente GmbH Bone Fixation Screws and Pins | K083912 |
2
16101338
Tecnología y Diseño Industrial, S.A..P.I. de C.V. Newfix® External Fixation System K101338 510(k) Summary
3.0 INTENDED USE AND INDICATIONS FOR USE
The Newfix® External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures.
4.0 DEVICE DESCRIPTIONS
- 4.1 The Newfix External Fixation System is a modular system that consists of various components including clamps, distractors, pins, carbon fiber rod, and stainless steel tubes for use in orthopedic and trauma treatment.
- 4.2 The system is a modular design to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of aluminum and stainless steel clamps (rod-to-rod and pin-to-rod), stainless steel fixation pins and stainless steel and carbon fiber connector rods. Pins include smooth and self drilling/self-tapping type threaded pin with diamond tip and cutting edges.
- 4.3 The Newfix® External Fixation System is supplied non sterile and is intended for single patient use. None of the components of the Newfix System are reusable. The Newfix® External Fixation System includes instruments and accessory devices necessary for its use.
3
Tecnologia y Diseño Industrial, S.A..P.I. de C.V.
COMPARISON OF DEVICE UNDER REVIEW AND ITS PREDICATI 5.0
| Comparison
Element | TDI Newfix® External Fixation
System K101338 | Orthofix Modulsystem Dynamic
Axial Fixation System K955848 | Synthes® External Fixation
System K961350, K011034, K090658 | XtraFix (Extrafix) External fixation
System K091258 | Comparison
Element | Materials | Duration of Use | Reuse Capability |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------|
| Manufacturer | Tecnología y Diseño Industrial
S.A.P.I. de C.V. | Orthofix | Synthes (USA) | ExtraOrtho (QFX Technologies) | TDI Newfix® External Fixation
System K101338 | Carbon fiber
Stainless Steel 17-4PH (AISI 630)
Stainless steel 304
Titanium alloys
Aluminum 6061-T6
Stainless steel 316LS | Greater than 30 days | Single use |
| Indication for/
Intended Use | The Newfix® External Fixation
System, consisting of axial fixators
and frame components, is indicated
for stabilization of open and/or
unstable fractures where soft tissue
injury precludes the use of other
fracture treatments such as IM
rodding or casting. NEWFIX®
External Fixation System is
intended for the fixation and for
temporary or extended stabilization
in cases such as: open fractures,
closed fractures, poly-trauma
fractures, supplement in the
stabilization of minimal fixations in
intra and extra articular fractures. | Orthofix Dynamic Axial Fixation
System is a unilateral external
fixation device, which is intended
for use in the treatment of bone
conditions including leg
lengthening, osteotomies,
arthrodesis, fracture fixation and
other bone conditions amenable to
treatment by use of the external
fixation modality." | The Synthes (USA) External Fixation
Systems (K961350, K011034,
K090658) are intended for use in the
construction of an external fixator
frame for the treatment of pediatric
and adult fractures. | The Extrafix External Fixation System
(K091258) includes various elements
designed to build a fixator construct. The
system includes clamps, posts, bars, and
fixation pins.
The Extrafix External Fixation System is
indicated for use in construction of an
external fixation frame for treatment of
long bone (foot, femur, and tibia) and
pelvic fractures that require external
fixation. Specifically, the system is
intended for:
o Temporary stabilization of open or
closed acute fractures with soft tissue
injuries;
o Definitive stabilization of open or closed
fractures where open or alternative
closed
treatment is undesirable or otherwise
contraindicated;
o Stabilization of fractures in the context
of polytrauma;
o Temporary or definitive stabilization of
certain pelvic fractures or pelvic ring
injuries;
o Arthrodesis and osteotomies with
associated soft tissue problems;
o Stabilization of limbs after removal of
total joint (knee and ankle) arthroplasty
for infection or other failure;
o Neutralization of fractures stabilized
with limited internal fixation;
o Stabilization of non-unions; and
o Intraoperative temporary stabilization
tool to assist with indirect reduction. | Orthofix Modulsystem Dynamic
Axial Fixation System K955848 | Aluminum, stainless steel,
titanium, and composite materials | Greater than 30 days | Single use |
| Synthes®. External Fixation
System K961350, K011034, K090658 | Clamps -Stainless steel and titanium
alloy
Dynamization Clip - Stainless steel
Rod Attachment - Stainless steel and
titanium alloy
Rods - Carbon fiber reinforced epoxy
(CFRE)
Screws - stainless, titanium alloys | Greater than 30 days | Single use | | | | | |
| XtraFix (Extrafix) External fixation
System K091258 | Aluminum, stainless steel, titanium, and
composite materials | Greater than 30 days | Single use | | | | | |
上101338
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Tecnologia y Diseño Industrial, S.A..P.I. de C.V.
Page 5 of 6
5
-101336
Tecnología y Diseño Industrial, S.A..P.I. de C.V. Newfix® External Fixation System K101338 510(k) Summary
5.1 Performance Tests
- 5.1.1 Performance tests were conducted to validate the locking mechanism of the Newfix External Fixation System against various components of the Orthofix predicate devices.
TDI Products tested:
- · E0300104 Lateral Cylinder for Pins (Straight Clamp).
- · E0600201 T-Shaped Clamp.
- . E0600301 Angled Clamp.
- E0600401 Ankle Clamp. I
- · E0900104/5 RadioLucent Wrist Axial Fixator Clamp.
Predicate Devices tested:
- · Orthofix ProCallus Fixator Straight Clamp
- · Orthofix T-Shaped Clamp
- Orthofix Ankle Clamp .
- · Orthofix RadioLucent Wrist Fixator Clamp
Materials used:
- · Ø6mm (0.236in) and Ø4mm (0.157in) series 316 stainless steel rods.
- Ø6mm (0.236in) and Ø4mm (0.157in) series 316 stainless steel rods with . a hexagonal nut for torque tests.
- . Socket Set Screws Flat Point ISO 4026 M8x1.25.
Measuring tools:
- · TDI.QC.023 PTS Analog push pull gauge SKN-5 S/N3409090760
- · TDI.QC.027 Dial torque wrench 6178A S/N 0207801708
Referenced Standards
- · ASTM F 1541 Standard Specification and Test Methods for External Skeletal Fixation Devices.
- · ASTM E 4 Practices for Force Verification of Testing Machines
6.0 CONCLUSION
- Interconnection testing per ASTM F 1541 and engineering analysis comparing lock 6.1 mechanisms demonstrated equivalence to predicates.
- The Newfix External Fixation System is substantially equivalent to the identified predicate 6.2 systems based on the substantial equivalence of indication for use, design features, operating principles, performance tests and material of composition.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Technologia y Diseño Industrial, S.A.P.I. de C.V. % Healthcare Technologies Consultants Mr. Robert Bard PO Box 506 South Lyon, Michigan 48178
MAR 1 4 2011
Re: K101338
Trade/Device Name: Newfix® External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: February 25, 2011 Received: March 01, 2011
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
7
Page 2 - Mr. Robert Bard
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.
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 vours.
Alvy B. Benson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indication for Use
510(k): K101338
Device Name: Newfix® External Fixation System
The Newfix® External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures.
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)
M. Melkerson
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k)_
Number K101338
510(k) Number