(406 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended surgical use of bone plates and screws, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an orthopedic implant system used for internal fixation of fractures, arthrodesis, and reconstruction in bones of the foot and ankle, which are structural interventions, not therapeutic in the sense of delivering treatment or therapy.
No
The device is described as an implantable system (plates and screws) used for surgical fixation in trauma and reconstructive procedures. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it consists of "various shape and size plates" and "cortical screw with multiple lengths and diameters," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in surgical procedures for trauma and reconstruction of bones in the foot and ankle. This is a direct medical intervention on the patient's body.
- Device Description: The description details plates and screws designed for internal fixation of bones. This is consistent with surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for surgical repair.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, ankle, distal tibia and fibula
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)
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
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.
K102429 / K131093, K152974 / K120359, K060514, K121601 / K100776 / K112583, K191009
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
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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
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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) |
|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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