Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.

Device Description

Traufix osteosynthesis medical devices are metal implants (stainless steel per ASTM F138, or ASTM F139, or titanium-alloy per ASTM F136) fixed adjacent to the bone for the treatment and consolidation of fractures, osteotomies, and/or joint ossification. The devices include different types and sizes of plates and screws.

AI/ML Overview

The provided text is a 510(k) summary for the Traufix osteosynthesis, osteotomy, and arthrodesis devices. It states that the device has been found substantially equivalent to predicate devices and therefore does not include a separate section outlining acceptance criteria or results from a study specifically designed to demonstrate meeting those criteria.

However, it does describe the non-clinical performance testing performed to support substantial equivalence. Based on the information provided, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with specific pass/fail thresholds. Instead, it describes comparative engineering analysis against predicate devices and adherence to ASTM/ISO standards.

Acceptance Criteria (Implied)	Reported Device Performance
Single cycle bend testing according to ASTM F382 (for plates)	Performed according to ASTM F382. (Implicitly, the device performed acceptably or comparably to the predicate for substantial equivalence).
Breaking torque testing according to ISO 6475 (for screws)	Performed according to ISO 6475. (Implicitly, the device performed acceptably or comparably to the predicate for substantial equivalence).
Structural properties comparison (bending stiffness, bending structural stiffness, and bending strength) per ASTM F382 A1 of subject proximal tibia plate vs. predicate proximal tibia plate	Engineering analysis performed. The conclusion of substantial equivalence implies these properties were comparable and did not raise new safety or effectiveness concerns.
Design and dimensions comparison with predicate plates and screws	Engineering analysis and comparison of technology performed. Minor differences were found but did not raise new questions of safety or effectiveness.

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

The document does not specify a "sample size used for the test set" in terms of number of devices or data points beyond stating that "non-clinical testing was performed in the subject devices." Given that this is a 510(k) summary for a medical device (bone fixation appliances), the "test set" would typically refer to the specific device designs and materials tested in the non-clinical mechanical tests. The provenance is internal testing conducted by or for Fixier, S.A. de C.V. It is retrospective in the sense that the testing has already been completed to support the 510(k) submission.

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

This is not applicable to the non-clinical performance testing described. Ground truth is not established by human experts in the context of mechanical performance tests against engineering standards.

4. Adjudication Method for the Test Set

This is not applicable to the non-clinical performance testing described. Adjudication methods are typically used in clinical studies or human expert review scenarios.

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 is not applicable. The device is a physical bone fixation implant, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

This is not applicable. The device is a physical bone fixation implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is defined by the industry standards and the properties of the legally marketed predicate devices. The testing aims to demonstrate that the subject device's mechanical properties are equivalent to or better than previously cleared devices, as measured by established ASTM and ISO standards for bend testing and torque testing.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical implant and does not involve AI or machine learning algorithms that require a "training set."

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

This is not applicable as there is no "training set" for this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image shows the date March 18, 2022. The text is written in a clear, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year. The text is centered and takes up most of the image.

FDA U.S. FOOD & DRUG
ADMINISTRATION

Fixier, S.A. de C.V. % Aurelia Brownridge Regulatory Affairs Consultant Aurelia Brownridge 11594 Cesped Drive San Diego, California 92124

Re: K201510

Trade/Device Name: Traufix osteosynthesis, osteotomy, and arthrodesis devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC

Dear Aurelia Brownridge:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 18, 2022. Specifically, FDA is updating this SE Letter as an administrative correction, as two copies of the SE letter were sent in error along with the Indications for Use statement for K201510, but not the 510(k) Summary.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shumaya Ali, M.P.H., OHT6: Office of Orthopedic Devices, (301) 796-2356, shumaya.ali@fda.hhs.gov.

Sincerely,

Shumaya Ali -S

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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February 18, 2022

Image /page/1/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Fixier, S.A. de C.V. % Aurelia Brownridge Regulatory Affairs Consultant Aurelia Brownridge 11594 Cesped Drive San Diego, California 92124

Re: K201510

Trade/Device Name: Fixier osteosynthesis, osteotomy, and arthrodesis devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 15, 2022 Received: January 20, 2022

Dear Aurelia Brownridge:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumava Ali -

Enclosure

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Indications for Use

510(k) Number (if known) K201510

Device Name

Traufix osteosynthesis, osteotomy, and arthrodesis devices

Indications for Use (Describe)

Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K201510

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.

510(k) Bundle: This submission includes a range of Fixier's products with the same regulation classification and regulation code name.

Date Summary Prepared: February 15, 2022

Manufacturer and Contact Information:

Submitter'sName	Submitter'sPhysical Address	Submitter'sContact Information
Fixier, S.A. deC.V.	Carretera Doctor Mora a San Miguelde Allende km 3.4, C.P. 37967Comunidad de San Rafael, DoctorMora, Guanajuato, México	Primary Official Contact:Aurelia BrownridgeRegulatory Affairs (Consultant)Telephone: 760-497-4354Secondary Contact:Vianey Mariana Perez SuarezBiological and PharmaceuticalChemistryRegulatory Affairs Chief
		Telephone: 011-52-419-688-11-91

Device and Classification Information:

Proprietary Name:	Traufix osteosynthesis, osteotomy, and arthrodesis devices
Common Name:	Plate, Fixation, Bone (primary)Screw, Fixation, Bone
Classification Name:	Single/multiple component metallic bone fixation appliances andaccessories (primary)Smooth or threaded metallic bone fixation fastener
Regulatory Class:	II
Product Codes:	HRS (primary)HWC
Regulation Number:	21 CFR 888.3030 (primary)21 CFR 888.3040

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Indications for Use: Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.

Description: Traufix osteosynthesis medical devices are metal implants (stainless steel per ASTM F138, or ASTM F139, or titanium-alloy per ASTM F136) fixed adjacent to the bone for the treatment and consolidation of fractures, osteotomies, and/or joint ossification. The devices include different types and sizes of plates and screws. The product's list is shown below:

Platetype	Platecode	Platedescription	Screwcode	Screw description	Surgicaltechnique #	Surgical techniquename
Minifragments	017	2.7 DCP Plates	064	2.7mm cortex screw		DCP plates
	207	2.0 DCP Plates	079	2.0mm cortex screw	TQ-005
	202&203	2.7mm L-plate	064	2.7mm cortex screw	TQ-032	T and L plates for3.5mm, 2.7mm, and2.0mm screws
	016	3.5mm One-third tubularplate	057	3.5mm cortex screw	TQ-004	3.5mm One-thirdtubular plate
			058	4.0mm cancellous screwpartially threaded
			059	4.0mm cancellous screwfully threaded
Smallfragments	110,111,172,&173	ALP titaniumdistal tibiaplates TIDIS &TIDIS-III	112	3.5mm titanium cortexscrew		ALP titanium distaltibia plateTIDIS I ANDTIDIS III
			106	3.5mm titanium cortexlocking screw	TQ-011
			107	3.5mm titaniumcancellous lockingscrew
	129	ALP titaniumproximalhumerus platePROH-LOCKLARGE	112	3.5mm titanium cortexscrew	TQ-014	ALP titaniumhumerus platePROH-LOCK andPROH-LOCKLARGE
			106	3.5mm titanium cortexlocking screw
			107	3.5mm titaniumcancellous lockingscrew
	144&145	ALP titaniumdistal lateralhumerus plateDH-LOCK	112	3.5mm titanium cortexscrew	TQ-017	ALP titanium distallateral humerusplate and ALPtitaniumDistal medialhumerus plate DH-LOCK
			106	3.5mm titanium cortexlocking screw
			107	3.5mm titaniumcancellous lockingscrew
			170	2.7mm titanium cortexlocking screw
	148,148S,149,&149S.	ALP titaniumdistal radiusplate LIONTER	154X	2.5mm titanium cortexscrew Torx drive	TQ-018	ALP titanium distalradius plate
			155X	2.5mm titanium cortexlocking screw Torxdrive

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Fixier
Traufix osteosynthesis, osteotomy and arthrodesis devices

Platetype	Platecode	Platedescription	Screwcode	Screw description	Surgicaltechnique #	Surgical techniquename
	164&165	ALP titaniumdistal tibiaplates TIDIS-III	112	3.5mm titanium cortexscrew	TQ-023	ALP titanium distalplate TIDIS II
			106	3.5mm titanium cortexlocking screw
			107	3.5mm titaniumcancellous lockingscrew
	023	4.5mmReconstructionplates	056	4.5mm cortex screw	TQ-009	Reconstructionplates
			060	6.5mm cancellous screw16mm thread
			061	6.5mm cancellous screw32mm thread
			062	6.5mm cancellous screwfully threaded
Largefragments	150&151	ALP titaniumproximal femurplate TLP	126	4.5mm titanium cortexscrew	TQ-019	ALP titaniumproximal femurplate TLP
			108	5.0mm titanium cortexlocking screw
			171	5.0mm titaniumcannulated cortexlocking screw
			109	5.5mm titaniumcancellous lockingscrew
			156	7.3mm titaniumcannulated cancellouslocking screw
	152&153	ALP titaniumproximal tibiaplate OPTIMUS	126	4.5mm titanium cortexscrew	TQ-020	ALP titaniumproximalTibia plateOPTIMUS
			108	5.0mm titanium cortexlocking screw
			109	5.5mm titaniumcancellous lockingscrew

SubstantialEquivalence:	Traufix osteosynthesis, osteotomy, and arthrodesis devices andpredicate devices have the same indications for use, targetpopulation, patient contact, materials, and sterilization methods.
	Traufix subject devices, and predicate devices are intended forfracture fixation and minor differences exist in the physical shapeand dimension characteristics of the plates and screws. However,these minor dimensional differences do not raise any newquestions of safety or effectiveness.
Primary PredicateDevice:	AUXEIN BRAND Of Bone Plates and Bone Screws & AUXEINBRAND Of DCS Plate System AUXEIN brand of Locking Platesand Locking Screws, (K141680)

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Other PredicateDevices:	-Synthes (USA) Modular Mini Fragment LCP System, (K063049)-Synthes (USA) Medial Distal Tibia Plates, (K001945)-Synthes Variable Angle Locking Compression Plate (VA-LCP),(K071184)-Synthes One-Third Tubular DCL Plate, (K011335)-Synthes 4.5mm LCP Straight Reconstruction Plates, (K051986)-Synthes (USA) LCP Proxima Humerus Plates, Long, (K041860)
Non-Clinical(Performance Testing):	-Non-clinical testing was performed in the subject devices asfollows:-Single cycle bend testing was performed according to ASTMF382.-Breaking torque testing was performed according to ISO 6475.-Engineering analysis was performed to compare thestructural properties per ASTM F382 A1 (bending stiffness,bending structural stiffness, and bending strength) of the proximaltibia plate (subject device) and proximal tibia plate (predicatedevice one).-Engineering analysis and comparison of technology was alsoprovided to compare design and dimensions of the subject andpredicate plates and screws.
Clinical Testing:	Clinical testing is not a prerequisite, as osteosynthesis, osteotomy,and arthrodesis implants conform to recognized standards and havewell established safety and performance characteristics. Therefore,clinical information is not necessary to demonstrate safety andeffectiveness or substantial equivalence.
Conclusion:	The Traufix osteosynthesis, osteotomy, and arthrodesis deviceshave been found to be substantially equivalent to the predicatedevices. Differences between the subject devices and the predicatedevices do not raise new questions of safety or effectiveness.

Regulation Number and Section

N/A