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.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Tecnolgia y Diseño Industrial, S.A.P.I. de C.V Newfix® External Fixation System K101338, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are established by demonstrating substantial equivalence to predicate devices through performance testing based on recognized standards. The key performance tests relate to the locking mechanism of the external fixation system.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Method)
Locking mechanism validation (per ASTM F 1541 for interconnection, and engineering analysis of lock mechanisms)	Demonstrated equivalence to predicate devices through:Performance tests comparing the Newfix® External Fixation System's locking mechanism to various components of Orthofix predicate devices.Engineering analysis of lock mechanisms.

Note: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than setting specific quantitative performance targets or thresholds for each component. The primary acceptance criterion is that the Newfix® system's locking mechanisms perform equivalently to those of the predicate devices when tested against the specified ASTM standard.

Study Information

Due to the nature of a 510(k) summary for a Class II medical device like an external fixation system, the "study" primarily consists of mechanical performance testing rather than clinical trials with human subjects.

Sample Size Used for the Test Set and Data Provenance:
- Test Set:
  - 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 for testing:
    - 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.
- Data Provenance: The testing was conducted by Tecnolgia y Diseño Industrial, S.A.P.I. de C.V. (located in Zapopan, Jalisco, Mexico) using their own products and commercially available predicate devices. The location of the testing laboratory is implied to be within their facilities, but a specific country of origin for the data itself beyond the manufacturer's location is not specified. This is a retrospective study in the sense that it compares a new device to existing predicate devices, but it involves prospective mechanical testing to generate new performance data.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This type of mechanical performance testing does not involve human experts establishing "ground truth" in the clinical sense (e.g., diagnosing a condition from an image). The "ground truth" for mechanical testing is based on established engineering standards (ASTM F 1541, ASTM E 4) and the performance characteristics of the legally marketed predicate devices. The "experts" involved would be the engineers and technicians performing the tests and analyzing the data to ensure compliance with the standards and equivalence to predicate performance. Their specific qualifications are not detailed in this summary.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving human interpretation of medical images or outcomes, to reconcile differing opinions among experts. This submission describes mechanical testing.
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:
- Not applicable. This is a 510(k) submission for a physical medical device (external fixation system), not an AI/imaging diagnostic device.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing is based on:
  - Engineering 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).
  - Performance of legally marketed predicate devices: The Newfix® system's locking mechanisms are shown to be equivalent to those of the identified Orthofix predicate devices.
The sample size for the training set:
- Not applicable. This describes performance testing for a physical medical device, not a machine learning model that requires a training set. The device itself is manufactured, and its components are subjected to testing.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a machine learning model.

Summary

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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

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K101138

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 fixationappliances 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 PredicateProduct
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, andFixation System	K101254
Treu-Instrumente GmbH Bone Fixation Screws and Pins	K083912

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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

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.

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

COMPARISON OF DEVICE UNDER REVIEW AND ITS PREDICATI 5.0

ComparisonElement	TDI Newfix® External FixationSystem K101338	Orthofix Modulsystem DynamicAxial Fixation System K955848	Synthes® External FixationSystem K961350, K011034, K090658	XtraFix (Extrafix) External fixationSystem K091258	ComparisonElement	Materials	Duration of Use	Reuse Capability
Manufacturer	Tecnología y Diseño IndustrialS.A.P.I. de C.V.	Orthofix	Synthes (USA)	ExtraOrtho (QFX Technologies)	TDI Newfix® External FixationSystem K101338	Carbon fiberStainless Steel 17-4PH (AISI 630)Stainless steel 304Titanium alloysAluminum 6061-T6Stainless steel 316LS	Greater than 30 days	Single use
Indication for/Intended Use	The Newfix® External FixationSystem, consisting of axial fixatorsand frame components, is indicatedfor stabilization of open and/orunstable fractures where soft tissueinjury precludes the use of otherfracture treatments such as IMrodding or casting. NEWFIX®External Fixation System isintended for the fixation and fortemporary or extended stabilizationin cases such as: open fractures,closed fractures, poly-traumafractures, supplement in thestabilization of minimal fixations inintra and extra articular fractures.	Orthofix Dynamic Axial FixationSystem is a unilateral externalfixation device, which is intendedfor use in the treatment of boneconditions including leglengthening, osteotomies,arthrodesis, fracture fixation andother bone conditions amenable totreatment by use of the externalfixation modality."	The Synthes (USA) External FixationSystems (K961350, K011034,K090658) are intended for use in theconstruction of an external fixatorframe for the treatment of pediatricand adult fractures.	The Extrafix External Fixation System(K091258) includes various elementsdesigned to build a fixator construct. Thesystem includes clamps, posts, bars, andfixation pins.The Extrafix External Fixation System isindicated for use in construction of anexternal fixation frame for treatment oflong bone (foot, femur, and tibia) andpelvic fractures that require externalfixation. Specifically, the system isintended for:o Temporary stabilization of open orclosed acute fractures with soft tissueinjuries;o Definitive stabilization of open or closedfractures where open or alternativeclosedtreatment is undesirable or otherwisecontraindicated;o Stabilization of fractures in the contextof polytrauma;o Temporary or definitive stabilization ofcertain pelvic fractures or pelvic ringinjuries;o Arthrodesis and osteotomies withassociated soft tissue problems;o Stabilization of limbs after removal oftotal joint (knee and ankle) arthroplastyfor infection or other failure;o Neutralization of fractures stabilizedwith limited internal fixation;o Stabilization of non-unions; ando Intraoperative temporary stabilizationtool to assist with indirect reduction.	Orthofix Modulsystem DynamicAxial Fixation System K955848	Aluminum, stainless steel,titanium, and composite materials	Greater than 30 days	Single use
Synthes®. External FixationSystem K961350, K011034, K090658	Clamps -Stainless steel and titaniumalloyDynamization Clip - Stainless steelRod Attachment - Stainless steel andtitanium alloyRods - Carbon fiber reinforced epoxy(CFRE)Screws - stainless, titanium alloys	Greater than 30 days	Single use
XtraFix (Extrafix) External fixationSystem K091258	Aluminum, stainless steel, titanium, andcomposite materials	Greater than 30 days	Single use

上101338

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

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-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.

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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.

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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

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Indication for Use

510(k): K101338

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)

M. Melkerson

(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices

510(k)_

Number K101338

510(k) Number

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.