(28 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical fixation, with no mention of AI/ML or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No.
The device is described as being used for suture or tissue fixation, specifically attaching soft tissues to bone, which is a structural repair function, not a therapeutic treatment of a condition or disease.
No
The FootHold™ System is described as a device for "suture or tissue fixation" and "to attach soft tissues to bone," indicating it is a surgical tool for repair and reconstruction, not for diagnosing conditions.
No
The device description clearly states it is a physical device ("preloaded with suture and is designed to attach soft tissues to bone") and describes mechanical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- FootHold™ System Function: The FootHold™ System is a surgical device designed to physically attach soft tissues to bone using suture. It is implanted directly into the body.
- Lack of Diagnostic Activity: The description does not mention any analysis of biological samples or the provision of diagnostic information. Its purpose is purely mechanical fixation within the body.
Therefore, the FootHold™ System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
FootHold™ System is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific indications are listed below:
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
Product codes (comma separated list FDA assigned to the subject device)
MBI
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.
- Materials: The FootHold™System implant components are manufactured from titanium alloy (ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, hand, wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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:
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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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 |
| Establishment | |
| Registration: | 3020584246 |
| Company: | CrossRoads Extremity Systems |
| 6423 Shelby View Dr., Suite 101 | |
| Memphis, TN 38134, USA | |
| Recently acquired by DePuy Synthes, Inc, the | |
| orthopaedics company of Johnson & Johnson | |
| Contact Person: | Kim Strohkirch |
| Vice President, QA/RA/Compliance | |
| CrossRoads Extremity Systems | |
| 901.221.8406 | |
| kstrohkirch@crextremity.com | |
| Trade Name: | FootHold™System |
| Common Name: | Fastener, Fixation, Soft Tissue |
| Classification: | Class II |
| Regulation Number: | 888.3040 Smooth or threaded metallic bone fixation |
| fastener | |
| Panel: | Orthopedic |
| Product Code: | MBI |
| Predicate Devices: | Primary Predicate: |
| K153585 FlipButton Suture Anchor | |
| 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. | |
| Indications for Use: | FootHold™System is intended to be used for suture or |
| tissue fixation in the foot, ankle, hand, and wrist. Specific | |
| indications 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: 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 | indications are listed below: | ||
| 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 | |||
| Material | Medical grade titanium alloy | ||
| (ASTM F136) | Medical grade titanium alloy | ||
| (ASTM F136) | |||
| PEEK (ASTM F2026) | Subset of | ||
| material of | |||
| predicate | |||
| Dimensions | Diameter: 1.1mm | ||
| Length: 4.0mm | Diameter: 1.1mm, 2.0mm, 3.4mm | ||
| Length: 4.0mm, 6.5mm, 10.0mm | Subset of | ||
| predicate | |||
| dimensions; | |||
| Suture: #2-0 –Premium UHMWPE | |||
| HS Fiber®, RB-0016VG (Riverpoint | |||
| Medical, K190817) Blue-Blue | Suture: #2-0 - #2 Force Fiber | ||
| Polyethylene Nonabsorbable Suture | |||
| (TeleFlex, K063778) | Substantially | ||
| equivalent | |||
| suture | |||
| 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.