Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, and MCP Joints for All Digits, Digital Tendon Transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction

Device Description

The FootHold™System is a device which is preloaded with suture and is designed to attach soft tissues to bone. The device is deployed through a bicortical drill hole and secured on the far cortex.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the FootHold™ System, which is a metallic bone fixation fastener. The information contained within this document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical and materials testing, rather than clinical study results with human participants or a machine learning component.

Therefore, the requested information regarding acceptance criteria, study design for machine learning models, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for AI devices is not applicable to this submission.

The "study" described in the document is a series of mechanical and materials tests to demonstrate the safety and effectiveness of the device.

Here's a summary of the relevant information provided:

Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria	Reported Device Performance
Abrasion Strength	Suture does not present a new worst-case for abrasion strength.	Mechanical testing demonstrated the suture does not present a new worst-case for abrasion strength.
Pull-out Strength	Performance substantially equivalent or improved compared to predicate device.	Bench testing showed a statistically significant improvement of pull-out strength for the subject device as compared to the listed predicate.
Sterilization	Sterility Assurance Level (SAL) of $10^{-6}$ (in conformance with ANSI/AAMI/ISO 11135-1).	SAL of $10^{-6}$ established. Residuals of ethylene oxide and ethylene chlorohydrin are below thresholds specified in ANSI/AAMI/ISO 10993-7.
Packaging Shelf Life	Meets acceptance criteria for labeling of 5-year shelf-life (ISO 11607-2).	Packaging met all acceptance criteria for labeling a 5-year shelf life.
Bacterial Endotoxin	Meets established limits.	Bacterial endotoxin testing meets the established limits.
Biocompatibility	Meets ISO 10993-1.	Based on comparative analysis, the subject FootHold™System meets ISO 10993-1 for biocompatibility. The results demonstrate the performance is substantially equivalent to the predicate device.

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This is a medical device application based on bench testing of physical properties, not a software device relying on clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth for mechanical testing is established by recognized standards and objective measurements (e.g., force, weight, material composition).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Testing is against predefined mechanical and material standards.
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 not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by engineering and biological standards (e.g., ASTM, ISO standards for material properties, sterility, and biocompatibility) and direct physical measurements of mechanical properties (pull-out strength, abrasion strength).
The sample size for the training set:
- Not applicable. This is not a machine learning device; there is no "training set" in the context of AI.
How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.

Summary

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April 15, 2022

Image /page/0/Picture/1 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 square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CrossRoads Extremity Systems, LLC Kim Strohkirch VP, QA/RA/Compliance 6423 Shelby View Drive, Suite 101 Memphis. Tennessee 38134

Re: K220797

Trade/Device Name: FootHold™ System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: March 17, 2022 Received: March 18, 2022

Dear Kim Strohkirch:

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.

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

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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 mediation-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.

For

Laura C. Rose, Ph.D. 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

Enclosure

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Indications for Use

510(k) Number (if known) K220797

Device Name FootHold System

Indications for Use (Describe)

FootHold™ System is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific indications are listed below:

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Crossroads Extremity Systems. The logo consists of a square made up of four smaller squares in the colors blue and green. To the right of the square is the company name, "Crossroads," in gray, with the trademark symbol next to it. Below the company name is the text "Extremity Systems" in a smaller font, also in gray.

510(k) Summary

Date:	April 14, 2022
Device Name:	FootHold™System
EstablishmentRegistration:	3020584246
Company:	CrossRoads Extremity Systems6423 Shelby View Dr., Suite 101Memphis, TN 38134, USARecently acquired by DePuy Synthes, Inc, theorthopaedics company of Johnson & Johnson
Contact Person:	Kim StrohkirchVice President, QA/RA/ComplianceCrossRoads Extremity Systems901.221.8406kstrohkirch@crextremity.com
Trade Name:	FootHold™System
Common Name:	Fastener, Fixation, Soft Tissue
Classification:	Class II
Regulation Number:	888.3040 Smooth or threaded metallic bone fixationfastener
Panel:	Orthopedic
Product Code:	MBI
Predicate Devices:	Primary Predicate:K153585 FlipButton Suture Anchor
Device Description:	The FootHold™System is a device which is preloaded withsuture and is designed to attach soft tissues to bone. Thedevice is deployed through a bicortical drill hole andsecured on the far cortex.
Indications for Use:	FootHold™System is intended to be used for suture ortissue fixation in the foot, ankle, hand, and wrist. Specificindications are listed below:

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Image /page/4/Picture/1 description: The image shows the logo for "CrossRoads Extremity Systems". The logo consists of a square made up of four smaller squares in the colors blue and green. To the right of the square is the text "CrossRoads" in a gray sans-serif font, with a trademark symbol in the upper right corner. Below the word "CrossRoads" is the text "Extremity Systems" in a smaller, lighter gray font.

Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments. Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for All Digits, Digital Tendon Transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction

Materials: The FootHold™System implant components are manufactured from titanium alloy (ASTM F136).
Substantial Equivalence: Mechanical testing and analysis of the worst-case FootHoId™System was performed to compare abrasion and construct pull-out strength for the subject and predicate devices. The results demonstrate the predicted performance of the FootHold™System is substantially equivalent to the predicate devices. There are no substantive differences between the FootHold™System and the cited predicates with respect to intended use and technological characteristics. The FootHold™System possesses the same technological characteristics as the predicate devices, including:
Predicted performance and method of stabilization, ●
Materials of manufacture, .
Basic design, and .
Mechanical properties.

Difference of suture strength and dimensions were evaluated, and the subject device is substantially equivalent to the predicate device.

	Subject Device	Predicate Device	Comparison
510(k)	N/A	K153585	Not applicable
Name	FootHoldTMSystem	Flip Button Suture Anchor	Not applicable
Images	Image: FootHold System	Image: Flip Button Suture Anchor	Not applicable
Product Code	MBI (888.3040 Smooth or threaded metallic bone fixation fastener)	MBI (888.3040 Smooth or threaded metallic bone fixation fastener)	Identical
Indications for Use	FootHoldTMSystem is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific indications are listed below:	The First Ray Flip Button Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific	Identical

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Image /page/5/Picture/1 description: The image shows the logo for Crossroads Extremity Systems. The logo consists of a series of four squares in the colors blue and green, followed by the word "Crossroads" in a sans-serif font. Below the word "Crossroads" is the phrase "Extremity Systems" in a smaller font. The logo is simple and modern, and the colors are bright and eye-catching.

	Subject Device	Predicate Device	Comparison
	Hand/Wrist: ScapholunateLigament Reconstruction, CarpalLigament Reconstruction,Repair/Reconstruction of CollateralLigaments, Repair of Flexor andExtensor Tendons at the PIP, DIP,and MCP Joints for All Digits, DigitalTendon TransfersFoot/Ankle: Lateral Stabilization,Medial Stabilization, AchillesTendon Repair, MetatarsalLigament Repair, Hallux ValgusReconstruction, Digital TendonTransfers, Mid-Foot Reconstruction	indications are listed below:Hand/Wrist: Scapholunate LigamentReconstruction, Carpal LigamentReconstruction, Repair/Reconstructionof Collateral Ligaments, Repair ofFlexor and Extensor Tendons at thePIP, DIP and MCP Joints for All Digits,Digital Tendon TransfersFoot/Ankle: Lateral Stabilization,Medial Stabilization, Achilles TendonRepair, Metatarsal Ligament Repair,Hallux Valgus reconstruction, DigitalTendon Transfers, Mid-FootReconstruction
Material	Medical grade titanium alloy(ASTM F136)	Medical grade titanium alloy(ASTM F136)PEEK (ASTM F2026)	Subset ofmaterial ofpredicate
Dimensions	Diameter: 1.1mmLength: 4.0mm	Diameter: 1.1mm, 2.0mm, 3.4mmLength: 4.0mm, 6.5mm, 10.0mm	Subset ofpredicatedimensions;
	Suture: #2-0 –Premium UHMWPEHS Fiber®, RB-0016VG (RiverpointMedical, K190817) Blue-Blue	Suture: #2-0 - #2 Force FiberPolyethylene Nonabsorbable Suture(TeleFlex, K063778)	Substantiallyequivalentsuture
Sterilization	Sterile - Ethylene Oxide	Sterile - Ethylene Oxide	Identical

Performance Testing: Mechanical testing was conducted to demonstrate the suture does not present a new worst-case for abrasion strength. Bench testing for mechanical pull-out strength shows that there was a statistically significant improvement of pull-out strength for the subject device as compared to the listed predicate.

A sterility assurance level (SAL) of 10-6 has been established in conformance with ANSI/AAMI/ISO 11135-1. The validation meets the residuals of ethylene oxide and ethylene chlorohydrin are below the thresholds specified in ANSI/AAMI/ISO 10993-7. Packaging has met all acceptance criteria for labeling of 5-year shelf life (ISO ISO11607-2). Bacterial endotoxin testing meets the established limits.

Based on the comparative analysis, subject FootHold™System meets ISO 10993-1 for biocompatibility. The results demonstrate the performance of the subject FootHold™System is substantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for Crossroads Extremity Systems. The logo consists of four squares in the colors blue and green, arranged in a 2x2 grid. To the right of the squares is the text "CrossRoads" in a gray, sans-serif font, with a trademark symbol after the word. Below the word "CrossRoads" is the text "Extremity Systems" in a smaller, light blue font.

Conclusion:

There are no substantial differences between the FootHold™System and the predicate devices with respect to intended use and technological characteristics, including basic design, materials of manufacture, mechanical properties, and intended effect.

Therefore, the FootHold™System can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.

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.