ALPHALOK Plating System

K230204 · Vilex, LLC · HRS · Apr 25, 2023 · Orthopedic

Device Facts

Record IDK230204
Device NameALPHALOK Plating System
ApplicantVilex, LLC
Product CodeHRS · Orthopedic
Decision DateApr 25, 2023
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3030
Device ClassClass 2
AttributesTherapeutic

Intended Use

The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include: - Forefoot, Midfoot, and Hindfoot Osteotomies - Metatarsals and Metacarpals Corrections and Osteotomies - Stabilization and Fixation of Metatarsal and Metacarpal Fractures - Stabilization and Fixation of Ankle Fractures - Syndesmosis Joint Stabilization - Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints - Flatfoot and Cavus Foot Corrections - Charcot Fixation. The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, and non-unions of the distal tibia and fibula such as: - Lateral Malleolar Fractures - Syndesmosis Injuries - Medial Malleolar Fractures - Bi-Malleolar Fractures - Tri-Malleolar Fractures - Posterior Malleolar Fractures - Distal Anterior Tibia Fractures - Vertical Shear Fractures of the Medial Malleolus - Pilon Fractures - Distal Tibia Shaft Fractures - Distal Fibula Shaft Fractures - Distal Tibia Periarticular Fractures - Medial Malleolar Avulsion Fractures - Lateral Malleolar Avulsion Fractures.

Device Story

ALPHALOK™ Plating System provides polyaxial locking bone fixation for orthopedic procedures. System comprises titanium alloy plates, screws, and washers; requires dedicated stainless steel instrumentation (wires, drills, drivers, guides). Used by surgeons in clinical settings to stabilize bone fractures, osteotomies, and non-unions in extremities. Device functions as mechanical support for bone healing; surgeon selects appropriate plate/screw configuration based on fracture pattern. Benefits include rigid fixation and anatomical stabilization of bone fragments.

Clinical Evidence

Bench testing only. Static four-point bend testing performed per ASTM F382-17. Biocompatibility, cleaning, and sterilization data leveraged from previous submissions (K212348, K221558).

Technological Characteristics

Implant components: Titanium alloy (Ti-6Al-4V, ASTM F136). Instrumentation: Stainless steel. Design: Polyaxial locking technology, low-profile plates. Testing: Static four-point bend testing (ASTM F382-17). Sterilization: ANSI/AAMI/ISO 17665-1.

Indications for Use

Indicated for patients requiring bone fixation, osteotomies, or fracture stabilization in upper and lower extremities (hand, wrist, foot, ankle, digits), specifically including distal tibia and fibula fractures, non-unions, and joint arthrodesis.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ April 25, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. Vilex LLC Brock Johnson President 111 Moffitt Street McMinnville, Tennessee 37110 Re: K230204 Trade/Device Name: ALPHALOK™ Plating 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 24, 2023 Received: January 25, 2023 Dear Brock Johnson: 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 {1}------------------------------------------------ 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 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, Shumaya Ali-S 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) K230204 Device Name ALPHALOK™ Plating System ### Indications for Use (Describe) The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include: - · Forefoot, Midfoot, and Hindfoot Osteotomies - · Metatarsals and Metacarpals Corrections and Osteotomies - · Stabilization and Fixation of Metatarsal and Metacarpal Fractures - Stabilization and Fixation of Ankle Fractures - Syndesmosis Joint Stabilization - · Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints - · Flatfoot and Cavus Foot Corrections - Charcot Fixation The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, and non-unions of the distal tibia and fibula such as: - · Lateral Malleolar Fractures - · Syndesmosis Injuries - · Medial Malleolar Fractures - Bi-Malleolar Fractures - Tri-Malleolar Fractures - · Posterior Malleolar Fractures - · Distal Anterior Tibia Fractures - · Vertical Shear Fractures of the Medial Malleolus - Pilon Fractures - · Distal Tibia Shaft Fractures - Distal Fibula Shaft Fractures - Distal Tibia Periarticular Fractures - · Medial Malleolar Avulsion Fractures - Lateral Malleolar Avulsion Fractures 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ # 510(k) Summary #### I. Submitter Vilex LLC 111 Moffitt Street McMinnville, TN 37110 Contact Person: Brock Johnson, President of Vilex Phone: (801) 916-4157 brock.johnson@vilex.com Date Prepared: May 27, 2022 | Device Proprietary Name: | ALPHALOKTM Plating System | |--------------------------|------------------------------------------------------------| | Common or Usual Name: | Bone Fixation Plates and Screws | | Classification Name: | Plate, Fixation, Bone - (Primary)<br>Screw, Fixation, Bone | | Regulation Number: | 21 CFR 888.3030<br>21 CFR 888.3040 | | Product Code: | HRS, HWC | | Device Classification | II | #### II. Device {5}------------------------------------------------ #### Predicate Device III. Substantial equivalence is claimed to the following devices: - . Stryker (Wright Medical) Ortholoc 3Di Ankle Fracture Plating System (K163044) -(Primary Predicate) - . Vilex ALPHALOK™ Plating System (K221558, K212348) -(Additional Predicate) #### IV. Device Description The ALPHALOK™ Plating System is a multi-indication solution providing polyaxial locking technology and low-profile plate designs. The ALPHALOK™ Ankle Fx plates and screws are intended to treat various fracture patterns of the ankle specifically tibia and fibula. The intent of this submission is to expand indications to include ankle fractures, whereas the previous submissions for the ALPHALOK™ Plating Systems (K221558, K212348) were for forefoot and midfoot respectfully. All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136). Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel. #### V. Indications for Use The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include: - Forefoot, Midfoot, and Hindfoot Osteotomies - Metatarsals and Metacarpals Corrections and Osteotomies ● - Stabilization and Fixation of Metatarsal and Metacarpal Fractures . - . Stabilization and Fixation of Ankle Fractures - Syndesmosis Joint Stabilization - . Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints - Flatfoot and Cavus Foot Corrections - Charcot Fixation . {6}------------------------------------------------ The ALPHALOK™ Ankle Fx Plates are intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as: - Lateral Malleolar Fractures ● - Medial Malleolar Fractures . - Bi-Malleolar Fractures - Tri-Malleolar Fractures - . Posterior Malleolar Fractures - Distal Anterior Tibia Fractures - Vertical Shear Fractures of the Medial Malleolus ● - Pilon Fractures . - Distal Tibia Shaft Fractures - Distal Fibula Shaft Fractures ● - Distal Tibia Periarticular Fractures - Medial Malleolar Avulsion Fractures - . Lateral Malleolar Avulsion Fractures - Syndesmosis Injuries #### VI. Comparison of Technological Characteristics The subject and predicate devices have similar intended uses and share identical core characteristics. The systems are intended to be used in the hand, foot, and ankle along with other bones of the upper and lower extremities. The subject and predicate systems include bone plates along with locking and nonlocking screws with similar implant designs made from titanium alloy material. Similar instrumentation is included in all the system. The inclusion of additional Ankle Fracture plates in this submission expands the original system; however, it is still comparable in scope to marketed systems such as Stryker (Wright Medical) Ortholoc 3Di Ankle Fracture Plating System (K163044). The technological differences between the subject device and predicate devices do not raise different questions of safety or effectiveness and substantial equivalence is demonstrated through the testing described below. {7}------------------------------------------------ #### Performance Data VII. The following performance data were provided in support of the substantial equivalence determination: - · Static four point bend testing per ASTM F382-17 In addition, cleaning and sterilizations, performed in accordance with ANSVAAMI/ISO 17665-1, from the applicant's own predicate device were leveraged. Biocompatibility, cleaning and sterilization are identical to K212348 and K221558. No changes have been made with respect to material, manufacturing, cleaning, or sterilization. ## VIII. Conclusion The information provided above supports the claim that the ALPHALOK™ Plating System is substantially equivalent to the predicate device. Although minor differences in design exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions with respect to substantial equivalence. Therefore, it is concluded that the ALPHALOK™ Plating System is substantially equivalent to the predicate device.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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