Who is the manufacturer of Foot and Ankle System?

Leith Medical, LLC filed the 510(k) submission for Foot and Ankle System (K200062).

What is the FDA product code for Foot and Ankle System?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Foot and Ankle System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Foot and Ankle System?

ORTHOLOC 3Di Ankle Plating System - Wright Medical Technology (K102429 / K131093); ORTHOLOC 3Di MTP Fusion Plate / ORTHOLOC 3Di Foot Reconstruction System - Wright Medical Technology (K152974 / K120359); Small Fragment Set - Stryker (K060514); LCP Anterolateral Distal Tibia Plates / Variable Angle LCP TMT Fusion Plates / 2.4/2.7Synthes 2.7mm/3.5mm Cortex Screw - Synthes (K121601 / K100776 / K112583); ARSENAL Foot Plating System - Trilliant Surgical (K191009).

Who can help prepare an FDA 510(k) submission like Foot and Ankle System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Foot and Ankle System

K200062 · Leith Medical, LLC · HRS · Feb 22, 2021 · Orthopedic

Device Facts

Record ID	K200062
Device Name	Foot and Ankle System
Applicant	Leith Medical, LLC
Product Code	HRS · Orthopedic
Decision Date	Feb 22, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Leith Medical Foot and Ankle System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.

Device Story

System comprises metallic bone plates and screws for orthopedic trauma and reconstruction. Plates feature low-profile, limited-contact design with radiused edges; include standard locking holes and oval holes for intraoperative compression. Cortical screws provided in multiple lengths/diameters. Used by orthopedic surgeons in clinical/OR settings for internal fixation of small bone fractures, osteotomies, and arthrodesis. Device provides mechanical stability to bone segments during healing; surgeon selects appropriate plate/screw size based on anatomy and fracture pattern. Benefits include rigid fixation to facilitate bone union and restore function.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by non-clinical bench testing including static and dynamic 4-point bending (ASTM F382-17), torsional properties, driving torque, and axial pullout (ASTM F543-17).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V, ASTM F136) and Nitinol (ASTM F2063). Design: Low-profile, limited-contact plates with locking and compression screw holes. Mechanical fixation via cortical screws. Standards: ASTM F382-17 (bending), ASTM F543-17 (torsion/torque/pullout), AAMI ST72 (endotoxins).

Indications for Use

Indicated for patients requiring open reduction, internal fixation, or arthrodesis of ankle, distal tibia, fibula, 1st TMT, or 1st MTP joints due to fractures, non-unions, degenerative joint disease, hallux valgus, or revision of prior procedures/implants. Screws indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, and fracture repair.

Regulatory Classification

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.

Predicate Devices

ORTHOLOC 3Di Ankle Plating System - Wright Medical Technology (K102429 / K131093)
ORTHOLOC 3Di MTP Fusion Plate / ORTHOLOC 3Di Foot Reconstruction System - Wright Medical Technology (K152974 / K120359)
Small Fragment Set - Stryker (K060514)
LCP Anterolateral Distal Tibia Plates / Variable Angle LCP TMT Fusion Plates / 2.4/2.7Synthes 2.7mm/3.5mm Cortex Screw - Synthes (K121601 / K100776 / K112583)
ARSENAL Foot Plating System - Trilliant Surgical (K191009)

Related Devices

K190391 — TDM Plate and Screw Systems · Tdm Co., Ltd. · Nov 15, 2019
K161894 — SurgTech Trauma System · Surgtech, Inc. · Feb 21, 2017
K202959 — PolyLock Plating System · Fusion Orthopedics, LLC · Nov 24, 2020
K142419 — Mini and Micro Fragments Reconstruction System-NEOFIX · Neoortho Productos Orthopedicos S/A · Dec 16, 2014
K222194 — Baby Gorilla®/Gorilla® Plating System · Paragon 28, Inc. · Aug 19, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ February 22, 2021 Image /page/0/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Leith Medical LLC % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401 Re: K200062 Trade/Device Name: Foot and Ankle System 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 21, 2021 Received: January 25, 2021 Dear J.D. Webb: 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 {1}------------------------------------------------ 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, For: Shumaya Ali, M.P.H. 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) K200062 Device Name Leith Medical Foot and Ankle System #### Indications for Use (Describe) The Leith Medical Ankle Fracture Plates are intended and designed for open reduction, internal fixation of ankle fractures, revision of ankle fractures, as well as osteotomies, and non-unions of the distal tibia and fibula. The Leith Medical First Tarsal-Metatarsal Joint (1st TMT) Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st TMT joint due to degenerative joint disease and/or hallux valgus, or revision of prior 1st TMT joint arthrodesis. The Leith Medical Medial Malleolar Fracture Plates are intended and designed for fixation of fractures, and non-unions of the distal tibia and fibula. The Leith Medical First Metatarsal Phalangeal Joint Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st MTP joint due to degenerative joint disease and/or hallux valgus, revision of prior 1st MTP joint arthrodesis, or revision of failed 1st MTP joint implant arthroplasty. The Leith Medical Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------| | <div> 区 Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary: Leith Medical Foot and Ankle System | Date Prepared | January 12, 2021 | |--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By | Leith Medical LLC 4705 Eagle Feather Dr Austin, TX 78735 | | Primary Contact | J.D. Webb 4313 W. 3800 S West Haven, UT 84401 512-590-5810 Tele e-mail: jdwebb@orthomedix.net | | Trade Name | Leith Medical Foot and Ankle System | | Common Name | bone plate & screws | | Classification Name | Single/multiple component metallic bone fixation appliances and accessories Smooth or threaded metallic bone fixation fastener | | Class | II | | Product Code | HRS / HWC | | CFR Section | 21 CFR section 888.3030 / 888.3040 | | Device Panel | Orthopedic | | Primary Predicate Device | ORTHOLOC 3Di Ankle Plating System - Wright Medical Technology (K102429 / K131093) | | Secondary Predicate Devices | ORTHOLOC ® 3Di MTP Fusion Plate / ORTHOLOC® 3Di Foot Reconstruction System - Wright Medical Technology (K152974 / K120359) Small Fragment Set - Stryker (K060514) LCP Anterolateral Distal Tibia Plates / Variable Angle LCP TMT Fusion Plates / 2.4/2.7Synthes 2.7mm/3.5mm Cortex Screw - Synthes (K121601 / K100776 / K112583 ARSENAL Foot Plating System - Trilliant Surgical (K191009) | | Device Description | The Leith Medical Foot and Ankle System consists of various shape and size plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, a highly radiused edge configuration, capability of dynamic/manual compression. All plates have standard screw holes with a locking feature, and some plates have oval screw holes for compressing the fracture intraoperatively. The system also consists of cortical screw with multiple lengths and diameters. | | Materials | Titanium alloy, Ti-6Al-4V (per ASTM F136) Nitinol (per ASTM F2063) | | Intended Use | The Leith Medical Foot and Ankle System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. | | Substantial Equivalence Claimed to Predicate Devices | The Leith Medical Foot and Ankle System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances. | | Indications for Use | The Leith Medical Ankle Fracture Plates are intended and designed for open reduction, internal fixation of ankle fractures, revision of ankle fractures, as well as osteotomies, and non-unions of the distal tibia and fibula. The Leith Medical First Tarsal-Metatarsal Joint (1st TMT) Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st TMT joint due to degenerative joint disease and/or hallux valgus, or revision of prior 1st TMT joint arthrodesis. The Leith Medical Medial Malleolar Fracture Plates are intended and designed for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula. The Leith Medical First Metatarsal Phalangeal Joint Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st MTP joint due to degenerative joint disease and/or hallux valgus, revision of prior 1st MTP joint arthrodesis, or revision of failed 1st MTP joint implant arthroplasty. The Leith Medical Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. | | Summary of the technological characteristics compared to predicate | Intended Use The Leith Medical Foot and Ankle System and the predicate devices are all intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. Materials The Leith Medical Foot and Ankle System uses the same material as the predicates. Design The Foot and Ankle System and the predicates are equivalent in terms of shape and function. Dimensions The Leith Medical Foot and Ankle System and the predicates are equivalent in their dimensions. Strength The Leith Medical Foot and Ankle System has greater or equivalent strength values compared to the predicates. | | Non-clinical Test Summary | The following analyses were conducted: ● Static and dynamic 4-point bending: ASTM F382-17 ● Torsional Properties: ASTM F543-17, Annex 1 ● Driving Torque: ASTM F543-17, Annex 2 ● Axial Pullout: ASTM F543-17, Annex 3 ● Bacterial Endotoxins Test (BET): AAMI ST72 | | | • Package Performance and Stability Testing | | | The results of these evaluations indicate that the Leith Medical Foot and Ankle System is equivalent to predicate devices. | | Clinical Test Summary | No clinical studies were performed | | Conclusions: Non- clinical and Clinical | Leith Medical considers the Leith Medical Foot and Ankle System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use | In accordance with 21 CFR 807.92 of the Federal Code of Regulations {4}------------------------------------------------ {5}------------------------------------------------