(90 days)
Not Found
No
The document describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Plating System bone plates, screws, and washers" intended for "fixation of bones and bone fragments in the upper and lower extremities," which directly addresses the treatment of injuries and conditions, fulfilling the definition of a therapeutic device.
No
Explanation: The ALPHALOK™ Plating System is used for the fixation of bones and bone fragments in fractures and osteotomies, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states that the ALPHALOK™ Plating System includes bone plates, screws, washers, and specific instrumentation (wires, drills, torx drivers, drill guides), all of which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ALPHALOK™ Plating System is described as bone plates, screws, and washers made of titanium, along with stainless steel instrumentation. These are physical implants and tools used within the body during surgical procedures.
- Intended Use: The intended use is for the fixation of bone fractures, osteotomies, and bone fragments in the extremities. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a device used for surgical repair and stabilization of bones, which falls under the category of surgical implants and instruments, not in vitro diagnostics.
N/A
Intended Use / 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
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
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. distal tibia and fibula.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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
§ 888.3030 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.
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
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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.
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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) |
| Screw, Fixation, Bone | |
| Regulation Number: | 21 CFR 888.3030 |
| 21 CFR 888.3040 | |
| Product Code: | HRS, HWC |
| Device Classification | II |
II. Device
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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 .
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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.
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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.