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.

The Newfix® External Fixation System lengthening components (rail systems) are unilateral external fixation devices and components intended for use in adults and pediatrics in the treatment of bone conditions including leg lengthening (osteotomies), arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality.

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.

TDI's Newfix® External Fixation System (Newfix External Fixation System 4.1 K101338 and Newfix Screws, Wires and Pins K101254 and this submission under review) consists of bone screws, pins and wires and external fixation components and lengthening systems. The System is utilized in the following manner: bone screws are inserted through the patient's skin and soft fissue and into the bone. The fixator frame of the Newfix® External Fixation System is attached to the shanks of the bone screws. The intended use and product technology of this submission have not changed from the earlier cleared submissions.

The present submission adds axial and pelvic fixation devices (including radiolucent wrist fixator), straight and angled clamps and rail lengthening transport systems.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Newfix® External Fixation System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Equivalency to Predicate Devices: Performance should be at least as safe and effective as legally marketed predicate devices.	Demonstrated equivalency through performance tests against various components of Orthofix predicate devices.
Locking Mechanism Validation: Validation of locking mechanism for various clamps (Lateral Cylinder, T-Shaped, Angled, Ankle, Radiolucent Wrist Axial Fixator Clamp).	Performance tests were conducted to validate the locking mechanism, with no specific quantitative results given, but the conclusion states equivalency was demonstrated.
Performance Testing for Specific Components: Successful testing for rail system for lengthening (dynamization clamp), multiplanar clamp, pelvic fixator and links, radiolucent wrist fixator, and radiolucent ankle clamp.	Performance testing for these components was completed successfully. Specific quantitative results are not provided; the conclusion implies they met the criteria for equivalency.
New Indications Performance: Performance testing supporting new indications for lengthening and arthrodesis.	Performance testing supporting these new indications were included in the reports and were successful.
"Worst Case" Construct Testing: Testing conducted using a worst-case construct as provided in ASTM F1541.	Testing was conducted using a worst-case construct as provided in ASTM F1541 in both static and dynamic testing modes.
Loosening of System Components: No observation of loosening of system components, including dynamization clamp, multiplanar clamp, and pelvic links.	Testing resulted in no observation of loosening of system components.
Adherence to Standards: Testing conducted according to ASTM F 1541 and ASTM E 4.	Referenced standards ASTM F 1541 (Standard Specification and Test Methods for External Skeletal Fixation Devices) and ASTM E 4 (Practices for Force Verification of Testing Machines) were used.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for the test set (e.g., number of devices tested). It lists the specific TDI products and predicate devices that were tested, but not the quantity of each or the number of tests performed.
Data Provenance: The origin of the data is not explicitly stated in terms of country or retrospective/prospective. Given that the applicant is from Mexico, it's possible that the testing was conducted there, but this is not confirmed. The testing seems to be prospective in nature, as it involves physical performance tests of manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the study did not involve human interpretation or subjective assessment of medical images or patient data to establish ground truth. The "ground truth" here is objective performance data (e.g., locking mechanism integrity, absence of loosening) derived from mechanical testing, measured against established engineering standards (ASTM).

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in human expert interpretations (e.g., in medical image reading studies). The current study involves physical performance testing with objective measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This submission is for a physical medical device (an external fixation system), not an AI/software device that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's mechanical integrity and functionality on its own.

7. The Type of Ground Truth Used

The ground truth used was objective performance data based on established engineering standards and comparative testing against predicate devices. Specifically:

Measurement of locking mechanism function and integrity.
Observation of component loosening.
Compliance with "worst-case construct" testing outlined in ASTM F1541.
Comparison of performance characteristics to legally marketed predicate devices.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical medical device. The concept of "training set" is relevant for machine learning algorithms, not for the mechanical validation of medical hardware. The design and manufacturing processes are iteratively refined rather than "trained."

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as #8.

Summary

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510(k) Summary

APR 1 9 2013

April 18, 2013

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) 383645 00 Ext. 2960+52 (33) 36245132

Fax: +52 (33) 383645 02

All questions and/or comments concerning this document should be made to:

Robert J. Bard, Esq. Managing Director HealthCare Technologies Consultants LLC PO Box 506 South Lyon, MI 48178

Tel: 248-573-5040 Cell: 734-330-5990 email: rbard@reglaw.net

Trade Name:	Newfix® External Fixation System
Common Name:	External Fixation System
Classification Name:	Single/multiple component metallic bone fixation appliancesand accessories
Classification Panel:	Orthopedic

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Tecnología y Diseño Industrial, S.A.P.I. de C.V. Newfix® External Fixation System 510(k) Summary K122210 Page 2 of 7

1.0 DEVICE SUMMARY

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 bonefixation appliances and accessories
Device Classification	Class II
Reviewing Panel	Orthopedic
Regulation Number	21 CFR 888.3030
Product Code	KTT

2.0 PREDICATE DEVICES

・

The Newfix® External Fixation System is substantially equivalent to the following predicate products.

		Newfix systems, devices and components - predicate associations
--	--	-----------------------------------------------------------------	--

Added system devices orcomponent	Manufacturer and Product	Cleared PredicateProduct
Radiolucent Wrist Fixator, AnkleClamp, Pelvic Fixator (T Clamp forPelvic Fixator and Straight Clamp forPelvic Fixator )	Orthofix Dynamic Axial FixationSystem (primary)EBI® XFIX® DFS and EBI® XFIX®(Access Pelvic Fixator)	K955848, K013540,K012024, K031919,K953406 K040935
Lengthener(Elongator) Systems	EBI® (Biomet® Carbon Rail DeformitySystem)Orthofix Adult Limb ReconstructionSystem	K991941, K000083,K010437, K021031,K033635, K081244

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INTENDED USE AND INDICATIONS FOR USE 3.0

Indications for Use:

Intended Purpose

NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: Exposed Fractures, Fractures of complex traces, Poly-fractures, Supplement in the stabilization of minimal fixations in intra and extra articular fractures.

The lengthening components are intended for fracture and/or deformities correction, and for diaphysary bone recovery.

4.0 DEVICE DESCRIPTIONS

TDI's Newfix® External Fixation System (Newfix External Fixation System 4.1 K101338 and
Newfix Screws, Wires and Pins K101254 and this submission under review) consists of bone screws, pins and wires and external fixation components and lengthening systems. The System is utilized in the following manner: bone screws are inserted through the patient's skin and soft fissue and into the bone. The fixator frame of the Newfix® External Fixation System is attached to the shanks of the bone screws. The intended use and product technology of this submission have not changed from the earlier cleared submissions.
4.2 The present submission adds axial and pelvic fixation devices (including radiolucent wrist fixator), straight and angled clamps and rail lengthening transport systems.
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.

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Tecnologia y Diseño Industrial, S.A.P.I. de C.V.
Newfix® External Fixation Systemal Fixation Systems
K122210

COMPARISON OF DEVICE UNDER REVIEW AND ITS PREDICATES 5.0

ComparisonElement	Manufacturer	Indication for/Intended Use
	TDINewfix ®External Fixation System	Tecnología y Diseño IndustrialS.A.P.I. de C.V.
		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.The Newfix® External Fixation System lengthening components (rail systems) are unilateral external fixation devices and components intended for use in adults and pediatrics in the treatment of bone conditions including leg lengthening (osteotomies), arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality..
	Orthofix Modulsystem Dynamic AxialFixation System and Adult LimbReconstruction System K955848	Orthofix
		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."
	Biomet EBI®XFIX® DFS AccessK953406 K013540, K081244	Biomet Trauma
		Unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality.For the XFIX® DFS® Rail System the indications are unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, acute or gradual correction and other bone conditions amendable to treatment by use of the external fixation modality
Comparison Element	TDI Newfix ®External Fixation System	Orthofix Modulsystem Dynamic Axial Fixation System and Adult Limb Reconstruction System K955848	Biomet EBI®XFIX® DFS Access K953406 K013540, K012024
Materials	Aluminum 6061-T6Stainless Steel 17-4PH (AISI 630),Stainless steel 304 Stainless steel 316LSTitanium alloys Carbon fiber	Aluminum,Stainless steel,Composite materials	Aluminum,Stainless steel,Titanium alloy, andCarbon fiber
Duration of Use	Greater than 30 days	Greater than 30 days	Greater than 30 days
Sterile or non sterile	Non Sterile requiring sterilization	Non Sterile requiring sterilization	Non Sterile requiring sterilization
Reuse Capability	Single Use	Single Use	Single Use

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. .

Tecnologia y Diseño Industrial, S.A.P.I. de C.V.
System

・

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5.1 Performance Tests

Performance tests were conducted to validate the locking 5.1.1 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.

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:

TD1.QC.023 PTS Analog push pull gauge SKN-5

S/N3409090760 TDI.QC.027 Dial torque wrench 6178A S/Ñ

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

5.1.2

TDI performance testing for the rail system for lengthening ( dynamization clamp), multiplanar clamp, pelvic fixator and links, radiolucent wrist fixator and radiolucent ankle clamp (as a fixator, clamp and for PEKK material) has been completed successfully.

Performance testing supporting new indications for lengthening and arthrodesis are included in the reports.

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Performance testing has evaluated the performance of these components in order to demonstrate that thev are as safe and as effective as legally marketed predicate devices.

Testing has been conducted using a worst case construct as provided in ASTM F1541using both static and dynamic testing modes.

Testing included Newfix components/systems in comparison against Orthofix systems as legally marketed predicate devices/systems.

5.1.3 Testing to evaluate loosening of system components including the dynamization clamp, mulitplanar clamp, and pelvic links as part of Newfix systems was conducted as part of the Performance Testing. Testing resulted in no observation of loosening of system components.

6.0 CONCLUSION

6.1 Testing per ASTM F 1541 and engineering analysis including component loosening compared to the predicate systems demonstrated equivalency.
6.2 The Newfix External Fixation System is substantially equivalent to the identified predicate systems based on the substantial equivalence of indication for use, design features, operating principles, performance tests and material of composition.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Technología y Diseño Industrial, S.A.P.I. de C.V. % HealthCare Technologies Consultants Mr. Robert J. Bard P.O. Box 506 South Lyon, Michigan 48178

Letter dated: April 19, 2013

Re: K122210 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: April 10, 2013 Received: April 11, 2013

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. 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.

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

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. Page 2 - Mr. Robert J. Bard

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N.Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k): 122210

Device Name: Newfix® External Fixation System

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)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

510(k)

Regulation Number and Section

§ 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.