The SafetyFix Easy Out System is indicated for temporary internal fixation and stabilization of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.

Device Description

The SafetyFix Easy Out System is an implant device previously cleared by the FDA for temporary internal fixation and stabilization of osteotomies and fractures during normal healing (Easy Out K141401). The only changes from the previously cleared device are the name change, addition of cannulated screws and the addition of a cannulated screw head option. There are no other changes to the SafetyFix Easy Out System when compared to the device cleared under K141401.

The SafetyFix Easy Out System consists of various cannulated and partially threaded solid screws designed to create lag compression and used for temporary internal fixation small bones and fragments. The SafetyFix Easy Out bone screws are self-tapping, self-drilling screws with thread diameters of 2.0, 2.5, 3.0, 3.5 and 4.0 mm, and lengths that range from 8 to 60 mm. All compression screws are fabricated from medical grade titanium alloy (per ASTM F-136). Associated instrumentation is available. All compression screws are offered non-sterilization prior to use.

AI/ML Overview

Here's an analysis of the provided text regarding the SafetyFix Easy Out System's acceptance criteria and studies:

Acceptance Criteria and Reported Device Performance

The device under review (SafetyFix Easy Out System, K180753) is a modification of a previously cleared device (Easy Out system, K141401). The primary acceptance criterion for the modified device is to demonstrate substantial equivalence to the predicate device, specifically that the added cannulated screws and modified screw head perform equivalently to the solid screws cleared in K141401 and do not raise new safety or efficacy concerns.

The reported device performance is that it functions as intended and the test results demonstrate substantial equivalence to the previously cleared device (K141401).

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Equivalence	Medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F-136 (identical to predicate)	Identical: The SafetyFix Easy Out System uses medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F-136.
Biocompatibility	Complies with ISO 10993-1 (identical to predicate)	Identical: The SafetyFix Easy Out System complies with ISO 10993-1.
Mechanical Performance	Dynamic and Static 3-Point Bend Strength: Equivalent to predicate (K141401 solid screws), tested according to ASTM F1264-03 (07).	Demonstrated Equivalence: "The verification activities have been summarized to demonstrate that the cannulated screws have equivalent dynamic and static testing results as the screws cleared in K141401." and "Static and dynamic 3-point bend tests... were conducted to support substantial equivalence."
	Static Torsional Strength: Equivalent to predicate (K141401 solid screws), characterized per ASTM F543-07(e1) and evaluated via engineering analysis.	Demonstrated Equivalence: "...static torsional tests... were conducted to support substantial equivalence." and "Furthermore, an engineering analysis was performed against the predicates to evaluate torsional strength... performance." The modified design is characterized as "more conservative."
	Axial Pull-Out Strength: Equivalent to predicate (K141401 solid screws), characterized per ASTM F543-07(e1) and evaluated via engineering analysis.	Demonstrated Equivalence: "...axial pull-out tests were conducted to support substantial equivalence." and "Furthermore, an engineering analysis was performed against the predicates to evaluate... pullout strength performance."
Functional Equivalence	The addition of cannulated screws and modified screw heads does not raise any new safety or efficacy concerns compared to the predicate device.	Confirmed: "...The addition of the cannulated screws does not raise any new safety or efficacy concerns" and "The addition of the modified screw head does not raise any new safety or efficacy concerns." The device performed "as intended" and is "substantially equivalent."
Intended Use	Identical to predicate: temporary internal fixation and stabilization of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.	Identical: "The SafetyFix Easy Out System intended use and indications for use (cleared under K141401) remain identical."
Principles of Operation	Identical to predicate.	Identical: "There have been no changes made to the principles of operation..."
Manufacturing Processes	Identical to predicate.	Identical: "...no changes made to the... manufacturing processes..."
Sterility	Provided non-sterile (identical to predicate).	Identical: The device is "Provided Non-sterile."
Single-Use	Single-use device (identical to predicate).	Identical: The device is "Yes" for single-use.

Study Details from the Provided Text:

This 510(k) submission is for a modification to an existing device, and therefore, the studies are focused on demonstrating equivalence rather than proving de novo safety and efficacy with clinical trials in humans.

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size (number of screws or tests for each type) used for the performance testing. However, it mentions "Performance testing was conducted to further characterize the performance of the SafetyFix Easy Out System's addition of the cannulated screws and modified screw head."
- Data Provenance: The data comes from non-clinical performance testing (mechanical bench testing) performed in a laboratory setting. There is no mention of human subject data or data from specific countries of origin beyond the general location of the sponsor and correspondent companies (USA). The study is non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. The ground truth for mechanical testing is established by engineering standards (ASTM F1264-03 (07), ASTM F543-07(e1)) and direct comparison with the mechanical properties of the predicate device (K141401), not by human expert consensus or clinical assessment of a test set.
Adjudication method for the test set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are used for clinical studies involving human interpretation or uncertain outcomes. For mechanical bench testing, results are objective measurements against predefined standards and comparative data.
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:
- No, an MRMC study was not done. This is a mechanical device, not an imaging or an AI-powered diagnostic device, so MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone study was not done. This is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this submission is established through physical and mechanical measurements against recognized industry standards (ASTM F1264-03 (07), ASTM F543-07(e1)) and direct comparative engineering analysis with the mechanical properties of the predicate device's solid screws.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical device testing as there is no machine learning or AI component that requires training data.
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.

Summary

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Special 510(k) Summary

SafetyFix Easy Out System

K 180753

1. Submission Sponsor

SafetyFix Medical Technologies, Inc.

8637 Delmar Blvd.

St. Louis, MO 63124 USA

Phone: (314) 983-0303

Fax: (314) 983-2777

Contact: Dr. Michael Horwitz

Title: President/CEO

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746 USA

Phone: (512) 327.9997

Contact: Ken Pilgrim

Title: Senior RA/QA Consultant

3. Date Prepared

22 March 2018

4. Purpose of the Submission

The purpose of this notification is to seek clearance for the modifications to the Easy Out system to: 1) Change the name to SafetyFix Easy Out System; 2) Incorporate the addition of cannulated screws; and 3) Incorporate the addition of a modified screw head for the cannulated screws.

5. Device Identification

Trade/Proprietary Name: SafetyFix Easy Out System

Common/Usual Name: Screw, Fixation, Bone

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Classification Name:	Smooth or threaded metallic bone fixation fastener
Regulation Number:	888.3040
Product Code:	HWC
Device Class:	Class II
Classification Panel:	Orthopedic

6. Legally Marketed Predicate Device

Primary Predicate:	K141401, Easy Out system, SafetyFix Medical Technologies, Inc. (formallyknown as Feet For Life Podiatry Centers)
Secondary Predicates:	K071092, Asnis™ Micro Cannulated Screw, Howmedica Osteonics Corp.

	K014154, Vilex/Duval/Orthex Cannulated Bone Screw Double Thread, Vilex,Inc.

7. Indications for Use Statement

8. Device Description

9. Description of Modification

This is a Special 510(k): Device Modification Submission. The basis for this submission is to: 1) Change the product name to SafetyFix Easy Out System; 2) Incorporate the addition of cannulated screws: and 3) Incorporate the addition of a modified screw head option for the cannulated screws. The verification activities have been summarized to demonstrate that the cannulated screws have equivalent dynamic and static testing results as the screws cleared in K141401.

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10. Substantial Equivalence Discussion

The SafetyFix Easy Out System intended use and indications for use (cleared under K141401) remain identical. There have been no changes made to the principles of operation, manufacturing processes, or materials from those that were previously cleared. Other than the incorporation of the design modifications described above, there have been no further modifications to the device.

Manufacturer	SafetyFix MedicalTechnologies, Inc.	Feet for Life PodiatryCenters	Similarities and Differences
Trade Name	SafetyFix Easy Out	Easy Out
510(k) Number	K180753	K141401	Not applicable
Common Name	Screw, Fixation, Bone	Screw, Fixation, Bone	Identical
Product Code	HWC	HWC	Identical
RegulationNumber	21 CFR § 888.3040	21 CFR § 888.3040	Identical
RegulationName	Smooth or threadedmetallic bone fixationfastener	Smooth or threadedmetallic bone fixationfastener	Identical
Intended Use	Intended to be used forinternal bone fixation	Intended to be used forinternal bone fixation	Identical
Indications forUse	The SafetyFix Easy OutSystem is indicated fortemporary internalfixation and stabilizationof osteotomies andfractures during normalhealing of ankle, elbowand small bones such asthose in the foot andwrist.	The Easy Out system isindicated for temporaryinternal fixation andstabilization ofosteotomies and fracturesduring normal healing ofankle, elbow and smallbones such as those in thefoot and wrist	Identical, apart from the product namechange
Overall Design	Medical grade titaniumalloy, partially threadedSolid and Cannulatedscrews	Medical grade titaniumalloy solid, partiallythreaded screws	The device modification is the addition ofthe cannulated screws to K141401, whichonly included solid screws. While minordesign differences exist, the intended useand principle of operation is substantiallyequivalent. Performance testingdemonstrates the safety and efficacy ofthe cannulated screws.
Material	Medical grade titaniumalloy (Ti-6Al-4V ELI) perASTM F-136	Medical grade titaniumalloy (Ti-6Al-4V ELI) perASTM F-136	Identical
Complies withISO 10993-1	Yes	Yes	Identical
Noncannulated	Ø2.0, Ø2.5, Ø3.0, Ø3.5,	Ø2.0, Ø2.5, Ø3.0, Ø3.5,	Identical screw options

		Table 5A – Comparison of Characteristics
Manufacturer	SafetyFix MedicalTechnologies, Inc.	Feet for Life PodiatryCenters	Similarities and Differences
Trade Name	SafetyFix Easy Out	Easy Out
ScrewDiameters	and Ø4.0 mm	and Ø4.0 mm
NoncannulatedScrew Lengths	12 to 60 mm	12 to 60 mm	Identical
CannulatedScrewDiameters	Ø2.0, Ø2.5, Ø3.0, andØ4.0 mmWedge head optionavailable in Ø2.0 mmonly	Not available; Removedfrom K141401	Different – This submission adds thecannulated screws. Performance testingconfirms the equivalence to the dataprovided in K141401.Static and dynamic 3-point bend tests,static torsional tests and axial pull-outtests were conducted to supportsubstantial equivalence.The addition of the cannulated screwsdoes not raise any new safety or efficacyconcerns
CannulatedScrew Lengths	8 to 60 mmWedge head optionavailable in 8 to 30 mmonly	Not available; Removedfrom K141401	Different – This submission adds thecannulated screws. Performance testingconfirms equivalence to the dataprovided in K141401.The addition of the cannulated screwsdoes not raise any new safety or efficacyconcerns
Compressionmechanisms	Spherical CompressionBall with Square ScrewHead	Spherical Compression Ballwith Square Screw Head	Identical
	Compression WedgeHead design with a Hexdriver	Not applicable	Different - the subject system introducesa more conservative compression wedgehead design. The addition of the modifiedscrew head does not raise any new safetyor efficacy concerns.
Sterile	Provided Non-sterile	Provided Non-sterile	Identical
Single-Use	Yes	Yes	Identical
Standardscomplied with	ASTM F1264-03 (07),ASTM F543-07e1	ASTM F1264-03 (07),ASTM F543-07e1	Identical

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11. Non-Clinical Performance Data

Performance testing was conducted to further characterize the performance of the SafetyFix Easy Out System's addition of the cannulated screws and modified screw head. The device functioned as intended and the test results demonstrate substantial equivalence to the previously cleared device (K141401). Static and dynamic 3-point bend tests, static torsional tests and axial pull-out tests were conducted to support substantial equivalence. Static and dynamic Three Point Bend testing was conducted in accordance with ASTM F1264-03 (07), Standard Specification and Test Method for Intramedullary

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Fixation Devices. Additionally, testing was conducted to characterize the torsional strength of the screw as well as axial pullout per ASTM F543-07(e1), Standard Specification and Test Methods for Metallic Medical Bone Screws.

Furthermore, an engineering analysis was performed against the predicates to evaluate torsional strength and pullout strength performance.

The results of this testing demonstrate that SafetyFix Easy Out System performs as intended and that the device is substantially equivalence to the previously cleared device (K141401).

12. Statement of Substantial Equivalence

The SafetyFix Easy Out System has the Identical intended use, principles of operation, and performance to the predicate device. The additional design characteristics of the modified device were tested in accordance with design controls, and verified to meet specifications. The SafetyFix Easy Out System, as modified, is determined to be substantially equivalent to the Easy Out system device cleared in K141401.

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Image /page/5/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SafetyFix Medical Technologies, Inc. % Ken Pilgrim Senior RA / QA Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K180753

Trade/Device Name: SafetyFix EasyOut System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 22, 2018 Received: March 22, 2018

Dear Ken Pilgrim:

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

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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); 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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

Enclosure

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Indications for Use

510(k) Number (if known) K180753

Device Name SafetyFix Easy Out System

Indications for Use (Describe)

The SafetyFix Easy Out System is indicated for temporary internal fixation of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.

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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Regulation Number and Section

§ 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.